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Clinical Trial Associate
2 months ago
Bicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our team and contribute to the successful management of our clinical study programs.
Key Responsibilities:- Support the clinical study team in overseeing CROs and managing studies, including planning, execution, and close-out of clinical trials
- Assist with vendor management and coordination
- Prepare and track study documents, including protocols, informed consent forms, and investigator brochures
- Set up and maintain electronic filing systems (eTMF) compliant with regulations
- Develop and maintain tracking tools for clinical operations teams
- Perform lab sample tracking and drug supply management
- Review data management aspects of clinical trials
- Support clinical operations functions during audits
- Participate in review and approval of clinical monitoring visit reports
- Assist with planning of investigator meetings and travel arrangements
- Interface with internal functions to coordinate information exchange
- Support invoice and budget activities for clinical trials
- Facilitate review of clinical trial agreements
- Identify potential risks and work with the CTM to resolve issues
- Bachelor's degree in a scientific or related field
- Familiarity with ICG, GCP, and FDA requirements
- Strong organizational and analytical skills
- Excellent interpersonal and communication skills
- Attention to detail and quality
- Proficiency with Microsoft Office
- Flexible approach to change
- State-of-the-art campus environment
- Flexible working environment
- Competitive rewards and bonus scheme
- Employee recognition schemes
- Generous annual leave and bank holidays
- Pension contribution
- Life assurance cover
- Private medical insurance
- Enhanced parental leave policies
- Group income protection
- Employee assistance program
- Health cash plan
- Access to company subsidized gym membership
- Option grant to subscribe to shares
- Cycle to work scheme
Bicycle Therapeutics is committed to building a diverse workforce and welcomes applications from all qualified candidates.