Clinical Project Manager
Vor 2 Tagen
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Job Title: Clinical Project Manager – Vaccines
Company Overview: Join a leading biotechnology company at the forefront of vaccine development, dedicated to improving global health through innovative solutions.
Position Overview: The Clinical Project Manager (CPM) will oversee the planning, execution, and completion of clinical trials for vaccine candidates. This role ensures that studies are conducted in compliance with ICH-GCP guidelines, regulatory requirements, and company standards.
Key Responsibilities:
- Project Leadership: Lead cross-functional teams to deliver clinical trials on time and within budget.
- Study Planning and Execution: Develop comprehensive project plans, including timelines, budgets, and resource allocation. Oversee study start-up, conduct, and close-out activities.
- Vendor Management: Select and manage Contract Research Organizations (CROs) and other external vendors to ensure quality and compliance.
- Regulatory Compliance: Ensure all clinical trials adhere to ICH-GCP guidelines, local regulatory requirements, and company Standard Operating Procedures (SOPs).
- Risk Management: Identify potential risks and develop mitigation strategies to ensure successful study outcomes.
- Budget Management: Monitor and control study budgets, ensuring financial objectives are met.
- Communication: Serve as the primary point of contact for internal stakeholders, study sites, and external partners.
- Documentation: Oversee the maintenance of the Trial Master File (TMF) and ensure all study documentation is accurate and up-to-date.
Qualifications:
- Education: Bachelor’s degree or higher in Life Sciences, Nursing, or a related field.
- Experience: Minimum of 5 years of clinical research experience, with at least 3 years in a clinical trial management role within a biotech or pharmaceutical company.
Skills:
- Strong knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
- Proven ability to lead cross-functional teams and manage multiple projects simultaneously.
- Excellent organizational, communication, and problem-solving skills.
- Proficiency in English; knowledge of German or French is advantageous.
- Competitive salary and performance-based bonuses.
- Comprehensive health and wellness benefits.
- Opportunities for professional development and career progression.
- Flexible working arrangements, including options for remote work.
Application Process: Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience and motivation for applying.
Join us in our mission to develop ground-breaking vaccines that make a difference in global health.
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