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sponsor based CTA

Employer
Labcorp
Location
Brussels, Belgium
Salary
Competitive
Start date
15 Oct 2020
Closing date
28 Oct 2020

View more

Discipline
Finance / Administration, Administration
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


Covance is looking to recruit experienced CTC/ CTA to join our sponsor in Belgium!

Responsibilities :

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 where 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 Legal Department)

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

- Ensure compliance with financial procedures

- Monitor and track adherence and disclosures,

- Budget closeout.
Education/Qualifications:
Bachelor of Science degree preferred or an equivalent scientific or commercial Higher Vocational Education with preferably experience in the healthcare field, pharmaceutical industry or clinical research.
Experience:

  • Minimum 1-2 years in Clinical Research or relevant healthcare experience
  • Fluent English, Dutch and French

If you would like to learn more:

📩 Natalija.Vukadinovic@covance.com
📞 +31 (0) 61 293 9571

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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