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Herakles Pharma


Functiegroep: Clinical Operations
Werkweek:40 uur
Procedure: W&S
Vacature ID:#586


De functie

Great CTA / Clinical Trial Coordinator (jr. CRA) position to start your career within clinical research! You can grow towards a CRA within 1-2 years. Experienced CTA’s are also welcome to apply. You will work for one of the most successful pharmaceutical companies, officebased, with homebased possibilities. Their core focus is oncology, but also other diseases.

In this position you will support and coordinate the logistic and administrative aspects of clinical research studies with a focus on oncology.

Trial and site administration:

  • Track (e.g. essential documents) and report (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents
  • Update clinical trial databases (CTMS) and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate/sign translation change request

Document management:

  • Prepare documents and correspondence
  • Collate, distribute/ship, and archive clinical documents, e.g. eTMF
  • Assist with eTMF reconciliation
  • Execute eTMF Quality Control Plan
  • Update manuals/documents (e.g., patient diaries, instructions)
  • Document proper destruction of clinical supplies.
  • Prepare Investigator trial file binders
  • Obtain translations of documents

Regulatory & Site Start-Up responsibilities: Collaborate witch other country roles to:

  • In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
  • Obtain, track and update study insurance certificates
  • Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
  • Publish study results for GCTO and RA where required per local legislation

Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:

  • Develop, control, update and close-out country and site budgets (including Split site budget)
  • Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
  • Track and report contract negotiations
  • Update and maintain contract templates (in cooperation with Legal Department)
  • Calculate and execute payments (to investigators, vendors, grants)
  • Ensure adherence to financial and compliance procedures
  • Monitor and track adherence and disclosures,

Meeting Planning:

  • Organize meetings (create & track study memos/letters/protocols)
  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Het profiel

CORE Competency Expectations:

  • Fluent in Dutch OR French PLUS English;
  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines;
  • Hands on knowledge of Good Documentation Practices;
  • Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required;
  • ICH-GCP Knowledge appropriate to role;
  • Excellent negotiation skills for CTCs in finance area.

Behavioural Competency Expectations:

  • Effective time management, organizational and interpersonal skills, conflict management;
  • Effective communication with external customers (e.g. sites and investigators);
  • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment;
  • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships;
  • Demonstrates commitment to Customer focus, both internally and externally;
  • Able to work independently;
  • Proactive attitude to solving problems / proposing solutions.

Inlichtingen bij

More information? / 0031(0)622639519

Meer informatie
Leonie Koomen 06-10518323
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