(Senior) Clinical Trial Associate - Sponsor Dedicated

Job Overview:

Covance is looking to recruit a CTA to join our sponsor in the Netherlands!!

Responsibilities / Duties:

TRIAL AND SITE ADMINISTRATION:

- Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)

- Ensure collation and distribution of study tools and documents o 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 o Assist with eTMF reconciliation

- Updating manuals/documents (e.g., patient diaries, instructions) o Document proper destruction of clinical supplies.

- Prepare Investigator trial file binders o Execute eTMF Quality Control Plan o Obtain translations of documents

REGULATORY & SITE START-UP RESPONSIBILITIES:

- 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 were required per local legislation

BUDGETING, AGREEMENT, AND PAYMENTS:

- Collaborate with finance/budgeting representatives for:

- Develop country and site budgets (including Split site budget) Tracking, and reporting of negotiations

- Maintenance of tracking tools

- Contract development, negotiation, approval, and maintenance (e.g. CTRAs)

- Update and maintain contract templates (in cooperation with the Legal Department)

- Payment calculation and execution (investigators, vendors, grants)

- Ensure compliance with financial procedures

- Monitor and track adherence and disclosures,

- Budget closeout.Education/Qualifications:University DegreeFluent English and DutchExperience:Minimum 1-2 years in Clinical Research or relevant healthcare experience

If you would like to learn more:

📩 Natalija.Vukadinovic@covance.com

📞 +31 (0) 61 293 9571