Clinical Trials Specialist
4 weeks ago
At Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Trials Specialist, you'll play a critical role in the management and preparation of Country Submissions in line with our global submission strategy.
Key Responsibilities:
- Prepare, review, and coordinate local regulatory submissions (MoH, EC, and additional special national local applications) in alignment with our global submission strategy.
- Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
- Coordinate project-specific local SIA services and ensure alignment with submissions activities and timelines.
- May have contact with investigators for submission-related activities.
- Key-contact at country level for Ethical or Regulatory submission-related activities.
- Coordinate with internal functional departments to ensure site start-up activities are aligned with submissions activities and timelines.
- Achieve PPD's target cycle times for site.
- May work with the start-up CRA(s) to prepare regulatory compliance review packages.
- May develop country-specific Patient Information Sheet/Informed Consent form documents.
- May assist with grant budgets and payment schedules negotiations with sites.
- Support the coordination of feasibility activities in accordance with agreed timelines.
- Enter and maintain trial status information onto PPD tracking databases in an accurate and timely manner.
- Ensure local country study files and filing processes are prepared, set up, and maintained as per PPD WPDs or applicable client SOPs.
- Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Requirements:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years).
- Effective oral and written communication skills.
- Excellent interpersonal skills.
- Strong attention to detail and quality of documentation.
- Good negotiation skills.
- Good digital literacy and the ability to learn appropriate software.
- Good English language and grammar skills.
- Basic medical/therapeutic area and medical terminology knowledge.
- Ability to work in a team environment or independently, under direction, as required.
- Basic organizational and planning skills.
- Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations.
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