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Onderzoek & ontwikkeling
#92051
Sint-Stevens-Woluwe
Fulltime
31-08-2020
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Project Assistant EMEA/APAC (m/f)

The Clinical Trial Assistant works on Clinical Trials by assisting the Clinical Trial Manager(s) with the conduct of the assigned clinical trial(s) (administration, coordination, archiving). You'll assist on the Clinical Operations Lead with organizing the Clinical Team Meetings. You help the Head of Clinical Operations with the development of template documents to be used within the Department as well as with the logistics of the departmental meeting.

The CTA assists the CTM with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Standard Operation Procedures (SOPs):

  • Assists with signature collection for CDAs, contracts, POs and insurance certificates in collaboration with CTM/Director Vendor Management
  • Develops and adapts documents to trial specific requirements in collaboration with the CTM
  • May assist with the preparation of trial reports for the trial team and keeping them up-to-date
  • Assists with organizing (agenda, meeting minutes, follow-up on action items) trial specific meetings, including but not limited to trial team meetings, Investigator Meetings.
  • Assists the CTM/COL to ensure that the essential Trial Documents at sponsor level are properly filed and made ready for archiving. Provides input to the other departments outside Clinical Operations to ensure that the needed documents are filed within the (e)TMF.
  • Assists in (electronic) Trial Master File review (TMF) to confirm completeness and follow-up of findings
  • The CTA may assist COL with:
  • The organisation of the clinical team meetings (agenda, meeting minutes, follow-up on action items)
  • The CTA helps the Head of Clinical Operations with:
  • The development of template documents to be used within the Department
  • The organization of the departmental meetings (agenda, meeting minutes, follow-up on action items)

SKILLS AND COMPETENCIES

  • Speaks and writes Dutch and English fluently
  • Knowledge of ICH-GCP
  • Knowledge of (e)TMF
  • Proficient in software applications such as Outlook, Word, Excel and PowerPoint
  • Experience with tools and systems for managing clinical trials such as MS project, trial progress and metric systems, eCRF, IXRS.

Wat wij van jou vragen:

  • Bachelor’s degree or University degree – medical or para-medical or equivalent by experience
  • Minimum of 3 years of experience in similar position within Clinical Operations
  • Biotech experience is a plus
  • Speaks and writes Dutch and English fluently
  • Knowledge of ICH-GCP
  • Knowledge of (e)TMF
  • Proficient in software applications such as Outlook, Word, Excel and PowerPoint
  • Experience with tools and systems for managing clinical trials such as MS project, trial progress and metric systems, eCRF, IXRS.


Wat wij jou bieden:

An international challenging environment. A temporary contract with the option of getting a fixed position.

Get in contact by e-mail: kylian.dewin@actief.be or by phone on 02 709 07 00 / 0472 18 72 68

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Vilvoordelaan 153
1930  Zaventem

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