Clinical Supply Manager

Clinical Supply Manager


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

The position as Clinical Supply Manager:

  • Plan and coordinate clinical trials and compassionate use programs
  • Close dialog and cooperation with our customers
  • Prepare and approve label text according to Annex 13
  • Order packaging materials and labels
  • Prepare packaging records and other study specific documents
  • Think out packaging design and blinding setup
  • Prepare distribution set up in coordination with our distribution team
  • Coordinate return and destruction of IMP
  • File GxP documents
  • Coordinate and collaborate with other COM/CRO´s
  • Ensure high quality level to meet customer and KLIFO requirements

The qualifications of the Clinical Supply Manager:

An ideal candidate is a person committed to creating and delivering solutions that meet individual customer needs. Also, the person must have an independent, positive, proactive and flexible personality
Our candidate is experienced with GMP and experienced within the pharmaceutical industry

We offer:

  • An inspiring working environment in a growing company
  • High job variation
  • High level of influence
  • Good social working environment and committed colleagues
  • Salary according to qualifications

Location:

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

Contact:

For more information, please contact Lotte Harreby, Director, at +45 44 222 960 or Pernille Smith, Team Manager, at +45 44 222 986

Applications should be sent to:

moc.ofilk@bojmarked “Clinical Supply 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: 01.08.2021

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KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany, Sweden and The Netherlands. 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


Clincial Trial Assistant München

Clinical Trial Assistant (CTA) für unser Büro in München


KLIFO GmbH suche einen Clinical Trial Assistant (CTA) für unser Büro in München

KLIFO A/S ist ein etabliertes Beratungsunternehmen im Bereich pharmazeutischer Entwicklungen mit Hauptsitz in Dänemark und Niederlassungen in Deutschland, Schweden und den Niederlanden. 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, Qualitätssicherung, 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 selbstbewusste 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 

  • Wünschenswert: Berufserfahrung als CTA
  • Wünschenswert: 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
  • 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

We 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 möglich (80%)

Standort:

Diese Position ist office-based in unserer Niederlassungin München

Ansprechpartner::

Für weitere Informationen wenden Sie sich bitte an Dr. Sibylle Gaupels, Team Manager for Clinical Project Management, KLIFO GmbH, unter +49 160 94143935.

Bewerbungen sind zu richten an:  moc.ofilk@ed-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).

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Project Manager - Clinical Operations Solutions, Glostrup, Denmark

Project Manager


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

KLIFO is expanding our office in Denmark and wants to engage an eTMF 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.

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
  • Solid 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

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Stefan Ingelsson, Team Manager, at +45 91 894 818

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: 14 June, 2021 (although applications are reviewed on an ongoing basis)

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eTMF Manager - Clinical Operations Solutions, Glostrup, Denmark

eTMF Manager


KLIFO is looking for a talented and committed eTMF Manager for our Glostrup office

KLIFO is expanding our office in Denmark and wants to engage an eTMF 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.

The position as eTMF Manager:

As eTMF manager in KLIFO you will be responsible for the continuous implementation and management of Veeva Vault eTMF and associated processes. The eTMF manager is also responsible for setting up, maintaining, closing and archiving the electronic Trial Master File to ensure inspection readiness of the eTMFs. The eTMF Manager is also responsible for providing comprehensive support to the clinical team for the set up and administration of projects conducted by KLIFO:

  • Participate in client’s kick-off meeting with the Clinical Team to align expectations on the TMF and related processes
  • Prepare and adapt the Trial Master File index for Sponsor and Investigator files according to the specific study
  • Create the study specific Filing Plan in alignment with the clinical team and the client
  • Create and maintain standardized templates for eTMF components and other essential documents, based on best practices and KLIFO’s procedures and in conjunction with Subject Matter Experts
  • Plan and perform periodic TMF oversight activities to ensure Inspection Readiness at all times
  • Ensure optimal use of eTMF functionality and industry best practices by transferring manual processes into automated workflows
  • Participate in client’s recurrent meetings to provide overview and status of the eTMF
  • Create guides for the eTMF set-up, maintenance and closure according to the TMF Milestones.
  • Create Essential Document Lists (EDLs), dashboards, reports and metrics acc. to the system, and ensure timely TMF quality control (QC)

The qualifications of the eTMF Manager:

  • Preferably a minimum of 2 years in a similar position in the pharmaceutical industry/CRO. Candidates within Business Administration, Librarian or equivalent
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Understanding of regulatory requirements, guidances and industry standards that govern TMF practices
  • Experience in management and filing clinical trial documentation
  • Ability to work in cross-functional teams
  • Strong organizational, written and verbal communication skills
  • Computer skills e.g. Microsoft Office Package
  • Previous knowledge of Veeva Vault is an advantage

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

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Rejane P. De Pádua, Team Manager, at +45 54 581 863

Applications should be sent to: moc.ofilk@boj marked eTMF 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: August 10, 2021 (although applications are reviewed on an ongoing basis)

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Senior Clinical Research Associate based in Denmark

Senior Clinical Research Associate based in Denmark


KLIFO is looking for a talented and committed Senior Clinical Research Associate based in Denmark

KLIFO is expanding our office in Denmark and wants to engage a Senior CRA 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 Senior CRA:

The Senior CRA is responsible for monitoring activities of trials across several sites and/or countries including pro-active site management and oversight:

  • Development of study specific plans in cooperation with Project Manager and sponsor
  • Prepare trial submission material for applications to Ethics Committee and review Regulatory Submission Packages
  • Performing feasibility and accessing suitability of clinical trial sites
  • Perform site initiation, monitoring and close-out visits
  • Participate in the Risk Based Quality Management process with focus on the monitoring strategy
  • Coordinate data cleaning activities in cooperation with data management
  • Training and supervision of CRAs in trial specific processes and perform co-monitoring visits
  • Function as Lead CRA if a trial has multiple sites including proactive site management and oversights

The qualifications of the Senior CRA:

  • 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/Biotech/CRO
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Excellent communication skills (written and verbal) in English
  • Experience with multi-country and multi-center trials
  • Ability to translate client´s needs into solid deliveries
  • Ability to work independently
  • Ability to supervise and coach non-senior personnel within the group

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 Denmark, Germany, Sweden and The Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Randi Rahbæk, Senior Director, KLIFO A/S at +45 44 778 704

Applications should be sent to: moc.ofilk@boj marked “Senior CRA”.

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:
19 May 2021 (although applications are reviewed on an ongoing basis)

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Biostatistician or Sr. Biostatistician for our Munich Office

Biostatistician or Sr. Biostatistician for our Munich Office


KLIFO is looking for a talented and committed Biostatistician or Sr. Biostatistician for our Munich office

For our German office (KLIFO GmbH) we now want to appoint a skilled and motivated (Senior) Biostatistician. The people we want to engage like to work in a consulting environment and have a positive, proactive, self-driven personality. We can offer a highly flexible, dynamic, free and trustful working environment. With exciting customers and projects in cooperation with competent colleagues. Where your knowledge, experience and your contribution are appreciated and highly valued.

The position as Biostatistician:

The Biostatistician is responsible for biostatistical deliverables on projects conducted by KLIFO (and can function as a mentor for other employees):

  • Provide statistical consultancy on general or trial related aspects, internally and externally
  • Cooperate closely with study team members such as data managers, programmers and project managers
  • Statistical planning of clinical trials: provide statistical input to trial designs and perform sample size calculations
  • Writing or peer review of the statistical sections of clinical trial protocols
  • Ensure appropriate randomisation procedures as applied
  • Writing or peer review of statistical analysis plans
  • Coordinate small teams of programmers, perform quality control of programs
  • Perform statistical analyses using SAS® (or other appropriate software)
  • Provide statistical contributions to clinical trial reports
  • Provide statistical support for publications
  • Interpretation and visualization of trial data
  • Provide input to Risk Based Quality Management (RBQM) including risk assessment and risk controls
  • Support maintenance and further development of internal standards and of Standard Operating Procedures
  • Ad-hoc tasks within the department

As Senior Biostatistician, you would in addition:

  • Act as the primary contact person for clients concerning statistical aspects
  • Act as mentor for other biostatisticians
  • Work with no or only minimal supervision

The qualifications of the Biostatistician

  • Diploma or master in (bio-)statistics, mathematics or comparable degree
  • At least 1-4 years professional experience with planning, analysis and reporting of clinical trials in the pharmaceutical or biotech industry, in a CRO or in an academic environment
  • Knowledge of relevant regulatory guidelines
  • Profound knowledge of SAS®
  • Good knowledge of Microsoft®Office
  • Good verbal and written communication skills
  • Fluent in English (spoken and written)
  • Proven knowledge of tasks and deliverables within biostatistics

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 an interactive, flexible and positive working environment

Location:

KLIFO has offices in Glostrup, Denmark, Munich, Germany, Lund, Sweden and Eindhoven, The Netherlands. This position is located at our office in Munich or in home office in Germany

Contact:
For more information, please contact Simone Ahrens-Mende, Director Data Management & Biostatistics, KLIFO GmbH at +49 1522 6355866.

Applications should be sent to:  moc.ofilk@boj marked “Biostatistician Munich Office”

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).

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Project Manager - Clinical Trials, Munich, Germany

Project Manager for our German office


Talented and committed Project Manager for our Munich Office

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, Germany and The Netherlands.

The German office 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 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 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

Qualifications:

  • MSc in the life science 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 with plan and budget
  • Willingness to travel
  • Excellent verbal and written communication skills
  • Fluent in English and in German(spoken and written)
  • Computer skills, ability to develop and maintain excel spreadsheets and to generate PowerPoint presentations

The ideal candidate is a dedicated team player, 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:

KLIFO has offices in Glostrup, Denmark, Munich, Germany, Lund, Sweden and Eindhoven, The Netherlands. This position is located at our office in Munich.

Contact:

For more information, please contact Sibylle Gaupels, Team Manager Project Management & Data Management, KLIFO GmbH at +49 160 94143935

Applications should be sent to:
moc.ofilk@boj marked “Project Manager Clinical Trials, 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.