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Clinical Trials Administrator (CTC) - Temporary Contract

Employer
Labcorp
Location
Madrid (Localidad), Comunidad de Madrid (ES)
Salary
Competitive Benefits
Start date
7 Oct 2019
Closing date
6 Nov 2019

View more

Discipline
Clinical Research, Study Site Coordinator
Hours
Full Time
Contract Type
Contract
Experience Level
Entry level

Job Details

Discover new opportunities to grow your career as a Covance FSP Clinical CTC working dedicated to our client a leading Pharmaceutical company in Madrid.

What is FSP?

At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).

As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.

Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.

With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.

Trial And Site Administration

RESPONSIBILITIES:

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 Labelling 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.

Meeting Planning

Candidates should ideally have a degree.

Candidates should have around at least 3 to 4 years experience working as a Clinical Trial Administrator.

Seniority Level

Associate

Industry

  • Biotechnology
  • Hospital & Health Care
  • Pharmaceuticals

Employment Type

Contract

Job Functions

  • Research
  • Analyst

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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