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Senior Clinical Trial Associate
2 months ago
Bicycle Therapeutics is seeking a highly skilled and detail-oriented Senior Clinical Trial Associate to join our clinical operations team. As a key member of our team, you will be responsible for administering, coordinating, and maintaining the logistical aspects of our clinical study programs.
Key Responsibilities- Study Management
- Support the clinical study team(s) with the oversight of Contract Research Organizations (CROs) and management of studies, including planning, execution, and close-out of clinical trials
- Assist with management of study-related vendors
- Document Management
- Assist the Clinical Trial Manager (CTM) in preparing Protocols, Informed Consent Forms, Investigator Brochures, and other study documents, and track revisions
- Support the CTMs in the set up and maintenance of the internal electronic filing systems (eTMF) compliant with regulations and in audit-ready state, as well as general study filing
- Tracking and Reporting
- Ensure that tracking tools are developed and maintained throughout the trials for the Clinical Operations teams
- Perform lab sample tracking, utilizing the central lab database
- Perform drug supply tracking and management
- Quality Control
- Review of data management aspects of clinical trials
- Perform QC of electronic Trial Master Files
- Communication and Collaboration
- Day-to-day contact with counterpart at CRO; daily review and identification of potential issues or problems with the sites and communicate/escalate to CTM or senior Clinical Operations staff
- Participate in the review and approval of clinical monitoring visit reports in conjunction with the CTM and track outstanding follow-up items as requested
- Participate in the review and finalization of study plans and circulate for approval
- Additional Responsibilities
- Assist CRO with planning of Investigator Meetings and associated travel
- Under the guidance and direction of the CTM, interface with other internal functions to coordinate relevant and timely exchange of information/materials to support clinical trials
- Support invoice and budget activities for clinical trials
- Facilitate review of clinical trial agreements such as contracts and licenses
- Identifies potential risks from study and site perspective and works with the CTM to assist in proactively resolving issues with CROs
- Education
- Bachelor's degree in scientific, biological, life sciences, or related field
- Experience
- Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management
- Skills
- Strong organizational skills and enjoys working in a methodical way
- Strong analytical and problem-solving skills
- Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
- Attention to detail and quality
- Excellent written and oral communication skills
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint)
- Desirable
- Early phase and/or Oncology experience
- Competitive Compensation
- Competitive salary and annual company bonus
- Benefits
- State-of-the-art campus environment with on-campus restaurant and Montessori nursery
- Flexible working environment
- Employee recognition schemes
- 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually
- Employer contribution to pension (employee does not have to contribute)
- Life assurance cover 4x basic salary
- Private Medical Insurance, including optical and dental cover
- Enhanced parental leave policies
- Group income protection
- Employee assistance program
- Health Cash Plan
- Access to company-subsidized gym membership
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
- Cycle to work scheme
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, color, gender, sexual orientation, age, disability status, marital status, or veteran status.
