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Senior Clinical Trial Associate
2 months ago
Bicycle Therapeutics is a biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our Clinical Operations team.
The successful candidate will be responsible for overseeing the logistical aspects of our clinical study programs, ensuring seamless execution and compliance with regulatory requirements. This role will involve effective communication with internal and external stakeholders, including Contract Research Organizations (CROs) and study personnel.
Key Responsibilities:
- Support the clinical study team in managing CROs and overseeing the planning, execution, and close-out of clinical trials.
- Assist in the management of study-related vendors and ensure compliance with regulatory requirements.
- Collaborate with Clinical Trial Managers (CTMs) to prepare study documents, including protocols, informed consent forms, and investigator brochures.
- Develop and maintain electronic filing systems (eTMF) compliant with regulations and ensure audit readiness.
- Track and manage study-related data, including lab sample tracking and drug supply management.
- Review data management aspects of clinical trials and ensure compliance with regulatory requirements.
- Support clinical operations functions during audits and inspections.
- Participate in the review and approval of clinical monitoring visit reports and track outstanding follow-up items.
- Assist in the review and finalization of study plans and circulate for approval.
- Develop and maintain comprehensive minutes for internal and external meetings.
- Interface with other internal functions to coordinate the exchange of information and materials to support clinical trials.
- Support invoice and budget activities for clinical trials.
- Facilitate the review of clinical trial agreements, including contracts and licenses.
- Identify potential risks and work with CTMs to proactively resolve issues with CROs.
Requirements:
- Bachelor's degree in a scientific, biological, or life sciences field.
- Familiarity with ICG, GCP, and FDA requirements for clinical trial management.
- Strong organizational and analytical skills, with attention to detail and quality.
- Excellent interpersonal and communication skills, with the ability to work independently and collaboratively in a dynamic team environment.
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint).
- Flexible approach to change and adaptability in a fast-paced environment.
Additional Information:
- Bicycle Therapeutics is committed to building a diverse and inclusive workforce that reflects the communities we serve.
- We offer a competitive rewards package, including annual bonuses, employee recognition schemes, and a comprehensive benefits program.
- Our state-of-the-art campus environment features on-site amenities, including a restaurant and Montessori nursery.
- We prioritize employee well-being and offer flexible working arrangements, as well as access to employee assistance programs and health cash plans.
