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.


Clinical Supply Coordinator

Clinical Supply Coordinator


KLIFO is looking for a Clinical Supply Coordinator for our Glostrup office

The position as Clinical Supply Coordinator:

As a Clinical Supply Coordinator you will support Clinical Supply Managers and be involved in supply activities, such as:

  • Prepare and approve label text according to Annex 13
  • Order packaging materials and labels
  • Prepare packaging records and other study specific documents
  • Control printed study specific labels
  • Coordinate return and destruction of IMP
  • File GxP documents
  • If relevant; Plan, coordinate and handle smaller clinical trials
  • Coordinate and collaborate with other CMO/CRO’s
  • Ensure high quality level to meet customer and KLIFO requirements

The qualifications of the Clinical Supply Coordinator:

An ideal candidate is a person committed to creating and delivering solutions that meet individual customer needs. Also, the person must have a positive, proactive and flexible personality.

Education, experiences, knowledge and skill:

The candidate must have relevant competencies and experiences including:

  • Pharmaconomist or equivalent
  • Experience from the pharmaceutical industry, biotech or CRO, preferably as a Clinical Supply Coordinator or similar
  • Ability to work in a flexible and changing environment
  • A high-quality mindset
  • Ability to prioritise different tasks to meet strict timelines
  • Team oriented personality with high degree of flexibility
  • Good communication skills (written and oral), in both Danish and English

We offer:

  • An inspiring working environment in a growing company
  • High job variation
  • High level of influence
  • Salary according to qualifications

Location:

KLIFO has offices in both Denmark, Germany and Sweden. This position is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Lotte Harreby, Director at +45 44 222 969 or Pernille Smith, Team Manager at +45 44 222 986

Applications should be sent to:

moc.ofilk@bojmarked Clinical Supply Coordinator. 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: 28 August 2020

View job post as a PDF.

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


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 before 21th August 2020, marked “Medical Writer”

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.


Senior Data Manager / Team Manager - for our Munich or Copenhagen office

Senior Data Manager/Team Manager


KLIFO is looking for a Senior Data Manager / Team Manager for our Munich or Copenhagen office

The position as Senior Data Manager/Team Lead:

Responsibilities of the Senior Data Manager/Team Lead include, depending on location of employment:

  • Normal sDM tasks such as
    • Program (within the eCRF system or in SAS®) various reports to provide status reports, medical review and management decisions
    • Perform quality control of programs
    • Writing or peer review of Data Management Plans and Data Validation Plans
    • Database set-up and testing, usually within an eCRF system including online edit checks
  • Cooperate closely with biostatisticians, medical reviewers and project managers
  • Support maintenance and further development of internal standards and of Standard Operating Procedures
  • Contribute to harmonization of data management processes between KLIFO offices
  • Taking lead in plans for CDISC implementation
  • Be involved in creating proposals for our clients
  • Supporting and leading the team of senior data managers in the local office
  • Business strategy and delivery within Data Management

The qualifications of the sDM/Team Lead:

The Senior Data Manager/Team Lead should possess the following qualifications and skills:

  • Professional data management experience in the pharmaceutical or biotech industry, in a CRO or in an academic environment
  • Experience with the use of eCRF systems to set up eCRFs and online checks and to perform continuous data management activities
  • Very good SAS® programming skills is an asset
  • Familiarity with CDISC standards
  • Knowledge of relevant regulatory guidelines
  • Analytical thinking, familiarity with medical terminology
  • Quality orientation, efficiency, and reliability
  • Customer orientation and flexibility
  • Willingness to travel occasionally
  • Fluent in English (spoken and written), and in German or Danish
  • People management skills

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player.

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)
  • Use – and elaborate – your competences and experience
  • A team of experienced colleagues
  • Work in a European-based company with global reach
  • Work in an interactive, flexible and positive working environment.

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

Contact:
For more information, please contact Christoffer von Sehested at moc.ofilk@detsehes.nov.reffotsirhC.

Applications should be sent to: moc.ofilk@boj marked sDM/TL.

Deadline: 15 July 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.


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 before 7th July 2020, marked “Project Manager Clinical Trials (DE)”.

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, Glostrup, Denmark

QA Specialist/Senior QA Specialist, GCP and GVP

 


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

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
  • 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

Location:
KLIFO has offices in both Denmark, Germany and Sweden. This position is located at our office in Glostrup, 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


Financial Controller, Munich, Germany

Financial Controller, Munich, Germany


KLIFO is looking for a Financial Controller for our Munich office 

KLIFO GmbH offers a job where you can greatly influence the development of local controlling and accounting. 

As the position as Financial Controller is new, an important role will be to develop, implement and execute local finance procedures and reports that supports the business, Group reporting and local requirements for reporting. 

You will have the full responsibility for financial support to our business in Germany and for delivering timely and correct reporting to our head office in Denmark. 

Accounting is outsourced, so you will have a close collaboration with the accounting firm in Munich, who takes care of bookkeeping, payroll, VAT and Tax calculations and yearly reporting to authorities. 

You will report to our General Manager in Munich with a dotted line to our CFO in Denmark. 

The position as Financial Controller:

  •  Based on Group reporting requirements, prepare correct and timely monthly reporting to KLIFO Group Finance 
  • Support local business in calculation of proposals to clients 
  • Prepare monthly invoicing to clients 
  • Prepare correct monthly recognition of income on projects with milestone payments 
  • Support and train local organisation in finance questions 
  • Close collaboration with outsourced local accounting company 
  • Develop relevant and needed processes and templates (excel) to support calculation of proposals, estimates, invoicing etc. 
  • In collaboration with Group Finance coordinate and prepare budget 

The qualifications of the Financial Controller:

  • Some years of experience as controller from a project based organisation.
  • Fluent in German and English 
  • Skilled user of Excel. 
  • Good communication skills 
  • Teamplayer 

We offer:

An opportunity to develop controlling and finance in a small organisation with a strong and dedicated plan for growth. We prioritize a positive working environment with opportunities to develop your skills. 

Location:

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

Contact:

For more information, please contact CFO Michael Krak at +45 44 222 901 

Applications should be sent to: moc.ofilk@boj marked ‘Financial Controller’.

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


Clinical Operations Project Manager, Glostrup, Denmark

Clinical Operations Project Manager


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

KLIFO is expanding and wants to engage a Project Manager with early clinical development experience 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: 

  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials in phase I-III
  • 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.

The qualifications of the Project Manager:

  • MSc in the life sciences field and a minimum of 5-6 years of overall experience out of which 3 years must be in project management in the pharmaceutical industry/BioTech/CRO
  • Experience with conduct of phase I trials
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Demonstrated project management skills including the ability to plan a project and operate within plan and budget
  • Excellent communication skills in English
  • Microsoft Office Skills

We offer:

KLIFO offers a job where you can: 

  • 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 is located at our office in Glostrup, Denmark. 

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 CTA.

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: 28 February 2020.

View job post as a PDF.

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