Director - Data Management and Biostatistics, Munich, Germany

New established position as Regulatory Affairs Officer


New established position as Regulatory Affairs Officer

KLIFO GmbH is currently expanding its service offering in Germany by introducing an end-to-end drug development consultancy including a Regulatory Affairs Solutions department, similar to what the company has in Denmark.

The Regulatory Affairs Officer is responsible for collaboration with clients as well as competent authorities and the execution of projects according to the clients´s expectations.

The position requires a hands-on approach to servicing existing and new clients in the DACH region.

You will report to our Senior Director New Business DACH in Munich with a dotted line to our VP Regulatory Affairs in Denmark.

The position as Regulatory Affairs Officer may involve:

  • Project management
  • Liaison with competent authorities
  • General regulatory affairs work
  • Management of regulatory procedures
  • Preparation and submission of CTA as well as other regulatory documents, e.g. (non-exhaustive list): Briefing packages, IMPD, IND, MAA/NDA, Variations, Renewals, changes in the clinical trials, notification at the end of the clinical trials
  • Writing and reviewing SOPs
  • Cross-functional collaboration within KLIFO
  • Participation in and support to projects in other KLIFO departments according to the training, experience and skills of the RA Officer

Qualifications:

  • Sc. in the life sciences field or RA specific diploma/master and a minimum 2 years of experience within Regulatory Affairs in the area of clinical research in the pharmaceutical industry/CRO
  • Excellent knowledge of regulatory requirements and ICH-GCP
  • Excellent communication skills (written and verbal)
  • Experienced user of Microsoft Office Package and good understanding of databases
  • Strong organizational skills with attention to details
  • Willingness to work from client sites, when required

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player, possesses excellent planning skills and is fluent, spoken and written, in English and Danish.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Join a team of experienced colleagues where you use and elaborate your skills and competences
  • Work in an interactive, flexible and positive working environment with a high level of transparency
  • Opportunity to join an European-based organisation with global reach and a strong and dedicated plan for growth

Location:

KLIFO has offices in Denmark, Germany and Sweden. This position is located at our office at Heimeranstrasse 35 in Munich.

Contact:

For more information, please contact Senior Director Christine Tiesler at +49 89 895286-31

Applications including salary expectations should be sent to: moc.ofilk@boj marked “Regulatory Affairs Officer, Munich”.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


Project Manager - Clinical Operations Solutions, Lund, Sweden

Project Manager


KLIFO is looking for a talented and committed Project Manager based in Sweden

KLIFO is expanding our office in Sweden and wants to engage Project Managers into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality.

We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Project Manager:

The Project Manager (PM) is responsible for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed quality, budget and timelines:

  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials
  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
  • Development of project plans for the conduct of the clinical trial. 
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team

The qualifications of the Project Manager:

  • BSc/MSc in the life sciences field and a minimum of 3-4 years in a similar position in the pharmaceutical industry/BioTech/CRO
  • Experience within clinical trial management, preferably within phase 1
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Ability to translate client’s needs into a solid project plan
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than in English)
  • Microsoft Office Skills

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia) 
  • Build international client relations 
  • Use and elaborate your competences and experience
  • Work in an interactive, flexible and positive working environment 

Location:

KLIFO has offices in both Denmark, Germany and Sweden. This position will be located at our office in Lund, Sweden.

Contact:

For more information, please contact Sara Hedman, Managing Director, KLIFO AB at +46 708 708 084

Applications should be sent to: 

moc.ofilk@boj marked Project Manager. KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline:
08 November 2020 (although applications are reviewed on an ongoing basis)

View job post as a PDF.


Medical Writers - Clinical Operations Solutions, Lund, Sweden

Medical Writers


KLIFO is looking for talented and committed Medical Writers based in Sweden

KLIFO is expanding our office in Sweden and wants to engage Medical Writers into a dynamic and experienced team within Clinical Operations Solutions. The areas covered by KLIFO also include Clinical Trial Supply Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Medical Writer:

The MW is responsible for creation of medical and scientific documents and the factual and formally correct display of scientific results and findings within clinical trials and non-interventional studies according to the FDA/EMA and ICH guidelines, i.e.:

  • Writing of clinical study protocols
  • Generation of clinical study reports
  • Generation of IBs and other documents related to the conduct of clinical trials and non-interventional studies
  • Generation of patient facing material, e.g. patient information
  • Support the project team in preparation and compilation of narrative safety reports
  • Advise the project team in preparation of study documents

The qualifications of the Medical Writer:

  • MSc in the life sciences field or related discipline, preferable with a PhD and a minimum of 3 years in a similar position in the pharmaceutical industry/CRO
  • Experience in medical writing, particularly in the creation of Clincial Study Protocols and Clinical Study Reports conforming to ICH-GCP
  • Good statistical understanding in the area of descriptive statistics
  • Ability to reproduce scientific data and complex issues accurately and in an understandable form
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Ability to translate client’s needs into a solid project plan
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
  • Microsoft Office Skills

In addition to the above-mentioned qualifications the ideal candidate is a service minded and collaborative team player that possesses planning skills, attention to detail and is fluent, spoken and written, in English and in a Scandinavian language.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use and elaborate your competences and experience
  • Work in an interactive, flexible and positive working environment

As KLIFO is a smaller service provider, you will experience a high level of transparency, influence and a good possibility for individual planning.

Location:

KLIFO has offices in both Denmark, Germany and Sweden. This position will be located at our office in Lund, Sweden.

Contact:

For more information, please contact Sara Hedman, Managing Director, KLIFO AB at +46 708 708 084

Applications should be sent to: moc.ofilk@boj marked MW.

Deadline: 

08 November 2020 (although applications are reviewed on an ongoing basis)

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany and Sweden. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement.

View job post as a PDF.


Director - Data Management and Biostatistics, Munich, Germany

Director – Data Management and Biostatistics


KLIFO GmbH is looking for a skilled and experienced
Director Data Management and Biostatistics

KLIFO A/S is a drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies in Europe, US and Asia to advance their drug development projects. We offer multi-disciplinary consulting and operational solutions spanning all areas of regulatory affairs, clinical research, clinical trial supply, CMC development, pharmacovigilance, and the development of pharmaceutical and biotech products and medical devices. KLIFO A/S currently has offices in Denmark, Sweden and Germany.

KLIFO now wants to appoint a Director Data Management and Biostatistics (DirDM-BioStats) into a dynamic and experienced team within our Clinical Operations Solutions team in Germany. The person we are looking for is a skilled and experienced Data Scientist and highly motivated professional and talented team leader with a positive, proactive, flexible and self-confident personality.

The position as Director DM-BioStats:

The DirDM-BioStats is the functional leader of the Data Management and Biostatistics department in our Munich office. The successful candidate will be responsible for defining the department business strategy, ensure highest quality deliverables, its continuous professional development and the alignment with overall corporate business and development needs and goals.

The main responsibilities of the successful candidate will be:

1) Business strategy and delivery:

  • Develop and drive the strategy and objectives of the Data Management & Biostatistics department.
  • Evaluation and implementation of suitable and cost effective systems and technical solutions that best support our business needs.
  • Leading role in the development and continuous update of processes, procedures and harmonizations.
  • Accountable for the group’s budget, scheduling, and performance standards (KPIs).
  • Driving continuous operational improvement, optimization of workflows and quality initiatives.
  • Ensuring best quality of deliverables according to highest standards and client expectations.

2) Functional leadership:

  • Ensure continuous professional development of the departmental services and capabilities.
  • Organizational alignment with actual and future business demand and needs.
  • Continuous development of department training plans incl. individual development of employees.
  • Effective and proactive resource management.
  • Act as a role model for, demonstrate and promote business awareness within the department.
  • Support of program and project level operational activities as applicable.

3) Business development and sales:

  • Supporting the Senior Director COS and corporate business development in development and execution of business development and sales strategies.
  • Contribution to the development of client proposals and in bid defense meetings.
  • Contribution to DM+Biostats related sales activities/initiatives.
  • Support the generation of repeat business by ensuring compliance with delivery on existing contracts.

The qualifications of the Director DM-BioStats:

The Director DM-BioStats should possess the following qualifications:

  • Proven knowledge of tasks and deliverables within the biostatistics and data management fields.
  • Awareness of current state of the art statistical and/or data management processes & procedures.
  • Knowledge of GCP and other applicable regulatory guidelines and requirements.
  • Profound knowledge of medical, data management and biostatistical terminology clinical trial processes and drug development.
  • Strong leadership and organizational skills including ability to motivate employees and teams.
  • Sc. in the life sciences field and at least 5-7 years’ experience in the pharmaceutical / BioTech / CRO industry.
  • Excellent verbal and written communication skills.
  • Fluent in English and German (spoken and written).
  • Good collaboration capabilities.
  • Like working in an international environment.

We offer:

We can offer a dynamic, inspiring and trustful working environment within a highly motivated team and a dynamic and growing international company with a diverse and exciting customer portfolio across all categories.

Contact:

For more information, please contact Dr. Nils Piwon, Senior Director Clinical Operations Solutions,
KLIFO GmbH at  +49 89 895286-0.

Applications should be sent to: moc.ofilk@boj marked “Director Data Management and Biostatistics”.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


KLIFO GmbH sucht einen Clinical Trial Assistant (CTA) (m/w/d) für unser Büro in München

KLIFO GmbH sucht einen Clinical Trial Assistant (CTA) (m/w/d) für unser Büro in München


KLIFO A/S ist ein etabliertes Beratungsunternehmen im Bereich pharmazeutischer Entwicklungen mit Hauptsitz in Dänemark und Niederlassungen in Deutschland und Schweden. Wir bieten sowohl Beratung als auch operative Dienste in allen Bereichen der Arzneimittel- und Medizinproduktentwicklung an. Dies beinhaltet Expertise bezüglich Herstellung und Kontrolle von Chemikalien (CMC), Regulatory Affairs, Qualitäts¬sicherung, Arzneimittelüberwachung, Planung und Durchführung von klinischen Studien (Clinical Operations Solutions) sowie Verpackung und Versand von Studienmedikation.

Die deutsche Niederlassung (KLIFO GmbH) benötigt in ihrem Münchner Büro Verstärkung im Bereich Clinical Operations Solutions durch eine(n) Clinical Trial Assistant (CTA, Projektassistenz) für die Durchführung von klinischen Studien. Wir suchen Mitarbeiter, die gerne in einem dynamischen und erfahrenen Team arbeiten und eine positive, proaktive, flexible, und selbst¬bewusste Persönlichkeit haben. Wir bieten ein flexibles, freies und vertrauensvolles Arbeitsklima mit unterschiedlichen Kunden, spannenden Projekten und kompetenten Kollegen, in denen Ihr Wissen, Ihre Erfahrung und Ihr Beitrag wertvoll sind und hoch geschätzt werden.

Die Position als Clinical Trial Assistant:
Der/die CTA ist verantwortlich für die umfassende Unterstützung des klinischen Teams beim Set-up und der Verwaltung von klinischen Prüfungen an Arzneimitteln oder Medizinprodukten oder nicht-interventionellen Studien:

  • Unterstützung des Projektmanagers und der Clinical Research Associates bei der Dokumentation, Archivierung und Verwaltung von Studien
  • Vorbereitung und Aktualisierung der Projektdatenbank, des Trial Master Files (TMF) und der Prüfarztordner
  • Vorbereitung von Einreichungsdokumenten zur Vorlage bei den zuständigen Behörden und Ethikkommissionen
  • Unterstützung bei der Entwicklung des TMF Plans
  • Verwaltung des Versands/Abholung von Studienmaterialien

Qualifikationen des Clinical Trial Assistant:

  • Vorteilhaft: Kenntnis der GCP-Richtlinien, der
    geltenden gesetzlichen Bestimmungen, der medizinischen Terminologie und der Abläufe bei klinischen Studien
  • Gute Kommunikationsfähigkeiten in Deutsch und Englisch (schriftlich und mündlich)
  • Gute Microsoft Office-Kenntnisse
  • Organisatorische Fähigkeiten
  • Genau und präzise mit Liebe zum Detail
  • B.Sc. im Bereich Biologie oder Pharmazie, medizinische Ausbildung oder vergleichbare Kenntnisse

Zusätzlich zu den oben genannten Qualifikationen ist der/die ideale Kandidat(in) ein kooperativer Teamplayer und dienstleistungsorientiert.

Wir bieten:

  • Arbeit in verschiedenen therapeutischen Bereichen an Aufgaben unterschiedlicher Komplexität
  • Arbeit mit einem heterogenen Kundenstamm (Pharma- oder Biotechunternehmen, Start-ups, Universitäten)
  • Einsatz und Ausbau Ihrer Kompetenzen
  • Arbeit in einer interaktiven, flexiblen und positiven Arbeitsumgebung
  • Ein Team von erfahrenen Kollegen
  • Arbeit in einem Unternehmen mit Sitz in Europa und globaler Reichweite
  • Festanstellung, Teilzeit ist ggf. möglich (80%)

Standort:
Diese Position ist office-based in unserer Niederlassung in München

Ansprechpartner:
Für weitere Informationen wenden Sie sich bitte an Dr. Nils Piwon, Senior Director Clinical Operations Solutions, KLIFO GmbH, unter +49 89 895286-0.

Bewerbungen sind zu richten an:
moc.ofilk@boj, Referenz: CTA Office Munich.

KLIFO verarbeitet Ihre Bewerbung und alle damit verbundenen personenbezogenen Daten ausschließlich für das konkrete Einstellungsverfahren. Ihre Daten werden als vertrauliche Informationen verarbeitet, vgl. das aktuelle Datenschutzgesetz (GDPR).

Stellenanzeigung als PDF.


Medical Writer - for our Munich office

Medical Writer


KLIFO is looking for a talented and committed Medical Writer

KLIFO A/S is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling. KLIFO A/S has offices in Denmark, Sweden and Germany.

KLIFO now wants to appoint a talented and commited Medical Writer into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Medical Writer:
The MW is responsible for creation of medical and scientific documents and the factual and formally correct display of scientific results and findings within clinical trials and non-interventional studies according to the FDA/EMA and ICH guidelines, i.e.:

  • Writing of study protocols
  • Generation of clinical study reports
  • Generation of IBs and other documents related to the conduct of clinical trials, non-interventional studies according to the FDA/EMA and ICH guidelines
  • Generation of patient facing documents, e.g. patient information
  • Support the project team in preparation and compilation of narrative safety reports
  • Advise the project team in preparation of study documents
  • Prepare and give presentations when required
  • Ad hoc tasks within the department and KLIFO
  • Develop and review of SOPs to support department activities

The qualifications of the Medical Writer:
The Medical Writer should possess the following qualifications:

  • MSc in the life sciences field or related discipline, preferable with a PhD and a minimum of 3 years in a similar position in the pharmaceutical industry/CRO
  • Experience in Medical Writing, particularly in the creation of Clinical Study Protocols and Clinical Study Reports conforming to ICH-GCP
  • Good statistical understanding in the area of descriptive statistics
  • Ability to reproduce scientific data and complex issues accurately and in an understandable form
  • Knowledge of SOPs, GCP guidelines, regulatory requirements, medical terminology and clinical trial processes
  • Excellent Microsoft Office skills
  • Excellent communication skills (written and verbal) in English as well as in German

In addition to the above-mentioned qualifications, the ideal candidate is action orientated, possesses good analytical skills, is able to make decisions and has strong planning and task management skills.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

Contact:
For more information, please contact Doris Wiegel, Managing Director KLIFO GmbH at +49 89 895286-0.

Applications should be sent to:  moc.ofilk@boj marked “Medical Writer”

Applications will be assessed on an ongoing basis.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


Project Manager - Clinical Trials, Munich, Germany

Project Manager, Clinical Trials – Munich, Germany


KLIFO is looking for a talented and committed Project Manager Clinical Trials in Germany

KLIFO A/S is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling. KLIFO A/S has offices in Denmark, Sweden and Germany. 

The German office (KLIFO GmbH) now wants to appoint a Project Manager for the conduct of clinical trials into a dynamic and experienced team within Clinical Operations Solutions in its Munich office. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and selfconfident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Project Manager (PM):

The Project Manager is overall responsible for managing the clinical trials, i.e.:

  • Main point of contact to sponsor representative
  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials
  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
  • Development of project plans for the conduct of the clinical trial.
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team
  • Ad-hoc tasks within the department and KLIFO
  • Develop and review of SOPs to support department activities
  • Monitoring of selected sites, e.g. KoL
  • When outsourced to a client and acting as Sponsor PM:
    • Carry out the CRO selection process and review CRO contracts with respects to tasks, budget and timelines
    • Lead the Sponsor oversight activities and ensure clear responsibility split between sponsor and CRO

The qualifications of the Project Manager:

The Project Manager should possess the following qualifications:

  • MSc in the life sciences field or a medical/veterinary degree and at least 5-6 years overall experience out of which 2 years in project management in the pharmaceutical industry/BioTech/CRO
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Demonstrated project management skills including the ability to plan and conduct an international, multicountry clinical trial and operate within plan and budget
  • Willingness to travel
  • Excellent verbal and written communication skills
  • Computer skills, ability to develop and maintain excel spreadsheets and to generate PowerPoint presentations.
  • Fluent in English and in German (spoken and written)

In addition to the above-mentioned qualifications, the ideal candidate is action orientated, able to make decisions and has strong planning and task management skills.

We offer

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

Location:

This position is office-based at our affiliate in Munich.

Contact:

For more information, please contact Doris Wiegel, Managing Director KLIFO GmbH at +49 89 895286-0. 

Applications should be sent to:

moc.ofilk@boj marked “Project Manager Clinical Trials (DE)”.

Application will be assessed on an ongoing basis.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Further information about KLIFO can be found at www.klifo.com

View job post as a PDF.


Clinical Operations Project Manager, Glostrup, Denmark

Clinical Operations Project Manager


KLIFO is looking for a talented and committed Project Manager (PM)

KLIFO is expanding and wants to engage a Project Manager into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

KLIFO is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions, Clinical Trial Supply Solutions, QA Solutions and Drug Development Counselling.

The position as Project Manager:

The Project Manager (PM) is responsible for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed quality, budget and timelines:

  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials
  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
  • Development of project plans for the conduct of the clinical trial.
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team

The qualifications of the Project Manager:

The Project Manager should possess the following qualifications:

  • BSc/MSc in the life sciences field or related discipline and a minimum of 3-4 years in a similar position in the pharmaceutical industry/CRO
  • Experience within clinical trial management
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Ability to translate client’s needs into a solid project plan
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
  • Microsoft Office skills

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

Location:

KLIFO has offices in both Denmark, Germany and Sweden. This position can either be located at our office in Copenhagen, Denmark or at our office in Lund, Sweden.

Contact:

For more information, please contact Jennie Wilborgsson, Clinical Research Director, COS, at +45 93 638 820. 

Applications should be sent to: moc.ofilk@boj marked PM.

Deadline: 12 June 2020

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


Clinical Trial Assistant (CTA) - Clinical Operations Solutions, Glostrup, Denmark

Clinical Trial Assistant (CTA)


KLIFO is looking for a Clinical Trial Assistant (CTA) for our Glostrup office

KLIFO is expanding and wants to engage a Clinical Trial Assistant into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

KLIFO is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Operations Solutions, Pharmacovigilance Solutions, Clinical Trial Supply Solutions, Regulatory Affairs Solutions, QA Solutions, CMC Development Solutions and Drug Development Counselling. KLIFO has offices in Denmark, Sweden and Germany.

The position as Clinical Trial Assistant:

The CTA is seen as a document manager and responsible for setting up and maintaining the Trial Master File as well as filing plans. Further, the CTA is responsible for providing comprehensive support to the clinical team for the set up and administration of projects conducted by KLIFO, i.e.:

  • Preparation and updating of the Trial Master Files and Investigators Files
  • Supporting the Project Manager and the Clinical Research Associates in the management of clinical trials
  • Management of shipment/retrieval of study materials
  • Supporting the Project Manager in meeting organisation

The qualifications of the Clinical Trial Assistant:

The Clinical Trial Assistant should possess the following qualifications:

  • A minimum of 2 years in a similar position in the pharmaceutical industry/CRO. Candidates within business administration or Librarian, or equivalent will also be considered
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Good communication skills (written and verbal)
  • Computer skills, ability to use the Microsoft Office Package (word, excel, etc)

In addition to the above-mentioned qualifications the ideal candidate is a service minded and collaborative team player that possesses planning skills, attention to detail and is fluent, spoken and written, in English and in a Scandinavian language.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech,investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

As KLIFO is a smaller service provider, you will experience a high level of transparency, influence and a good possibility for individual planning. KLIFO is located in Smedeland 36, 2600 Glostrup. Further information about KLIFO can be found at www.klifo.com

Contact:

For more information, please contact Tina Hjorth, Senior Clinical Research Director, COS, at 44 222 934

Applications should be sent to: moc.ofilk@boj marked CTA.

Deadline: 12 June 2020.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


QA Specialist/Senior QA Specialist

QA Specialist/Senior QA Specialist, GCP and GVP

 


KLIFO is looking for a QA Specialist/Senior QA Specialist, GCP and GVP

The position as QA Specialist/Senior QA Specialist:
We are a growing QA department where we need a new colleague with competencies regarding GCP and GVP. GLP experience will be a benefit. The job will be a mixture of internal and external QA activities.

The external activities can be:

  • QA consulting to Clients
  • Provide various QA services to Clients. E.g.:
    o Develop or update QMS system
    o GAP analysis
    o Help to become Inspection ready
  • Performing worldwide Client Audits

The internal tasks will mainly be:

  • Maintain the Quality Management System within the Clinical Area
  • Perform Training within the Clinical area
  • Ensure execution of the Clinical audit program
  • Participate in KLIFO projects as QA representative
  • Participate as QA representative in customer audits and inspections

Beside the above activities, be responsible for KLIFOs GDPR compliance review program.

The qualifications of the QA Specialist/Senior QA Specialist:
You are MSc in the life science field and the ideal candidate for the position is a trained lead auditor with at least 7 years of QA experience within GCP and GVP in the pharmaceutical industry. GLP QA and GLP auditing experience is considered a benefit.
You must be flexible and service-minded, a team player but also thrive working as a consultant and be capable of taking on a varity of different tasks and make decisions on your own.
Willingness to work from client sites, when required and to travel to the extend necessary.
Fluent in one of the Scandinavien languages and in English.

We offer:
Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
Join a team of experienced colleagues where you use and elaborate your skills and competences.
Work in an dynamic, flexible and positive working environment in a rapidly developing company.
You will experience a high-level of transparency and influence.

A flexible work schedule can be a possibility.

Location:
KLIFO has offices in both Denmark, Germany and Sweden. This position can be located at our office in Sweden or in Denmark.

Contact:
For more information, please contact Anne Ploug Jørgensen, Director, QA, mobile phone +45 44 222 982.

Applications should be sent to: moc.ofilk@boj marked QA Specialist/Senior QA Specialist GCP and GVP.
KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR). 

Deadline: Recruitment interviews will be held on an ongoing basis.

View job post as a PDF.

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany, and Sweden. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. For more information, visit www.klifo.com