MSD Clinical Trial Coordinator CTC 

Netherlands, North Holland 

233748439

Job Description

Purpose of the role

Reporting into the COM-Lead you will be responsible for comprehensive trial and site administration that involves preparing, collating, distributing and archiving clinical documents. As CTC you support clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages and site-specific Informed Consent Forms (ICFs), if applicable. Besides working independently, you will collaborate at local level closely with COMs, CRMs and CRAs. You will support the teams to manage Clinical Trial Research Agreements (CTRAs) and payments within the specified timelines. With a proactive attitude you propose solutions towards solving problems within a matrix multicultural environment.

Trial and site administration:

• 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, in collaboration with other country roles (if applicable).
• Prepare local study meetings with needed CTC updates.

Document management:

• Prepare documents.
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF.
• Update manuals/documents
• Document proper destruction of clinical supplies.
• Prepare Investigator Site File binders.
• Obtain translations of documents

Regulatory & Site Start-Up responsibilities: Collaborate with 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.
• Support preparation of submission packages and ICFs

Budgeting, Agreement and Payments:

• Develop, control, update and close-out country and site budgets.
• Track and report contract negotiations
• Prepare budget configurations and execute payments.
• Ensure adherence to financial and compliance procedures.
• Maintain Tracking Tools
• Obtain and process FCPA documentation in a timely manner.

Your profile:

• Completed job training in office management, administration, finance, health care preferred or bachelor’s degree.
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices
• Effective time management, organizational and interpersonal skills, conflict management
• Effective communication with internal and external customers (e.g. departments outside GCTO, sites and investigators)
• Team Player and positive mindset

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary
• 35,5 days of leave;
• Attractive collective health care insurance package with considerable reduction rates;
• Solid Pension Plan;
• Incentive Plan;
• Numerous training, coaching and e-learning modules for long term job opportunities and development.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.