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Senior Clinical Trial Associate
2 months ago
Bicycle Therapeutics is a clinical-stage pharmaceutical 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.
Key Responsibilities- Support the clinical study team in overseeing CROs and managing studies, including planning, execution, and close-out of clinical trials.
- Assist with the management of study-related vendors and ensure compliance with regulations.
- Collaborate with the Clinical Trial Manager (CTM) in preparing study documents, tracking revisions, and maintaining electronic filing systems.
- Develop and maintain tracking tools for the Clinical Operations team and perform lab sample tracking using the central lab database.
- Review data management aspects of clinical trials and support clinical operations functions during audits.
- Participate in the review and approval of clinical monitoring visit reports and track outstanding follow-up items.
- Perform quality control of electronic Trial Master Files and ensure that agendas for meetings are clear and distributed in advance.
- Assist with the planning of Investigator Meetings and associated travel, and interface with other internal functions to coordinate relevant information.
- Bachelor's degree in a scientific, biological, or life sciences field.
- Familiarity with ICG, GCP, and FDA requirements for clinical trial management.
- Strong organizational, analytical, and problem-solving skills, with excellent interpersonal and communication skills.
- Proficiency with Microsoft Office and a flexible approach to change.
- A state-of-the-art campus environment with on-campus amenities.
- A competitive reward package, including annual bonuses and employee recognition schemes.
- Flexible working environment and opportunities for professional growth.
Bicycle Therapeutics is committed to building a diverse and inclusive workforce that reflects the communities we serve. We welcome applications from qualified candidates and are an equal opportunities employer.
