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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.
Job SummaryThe Senior Clinical Trial Associate will be responsible for administering, coordinating, and maintaining the logistical aspects of our clinical study programs. This role will involve effective communication with internal and external study personnel, as well as facilitating the activities associated with the successful clinical trial management and execution of our clinical programs.
Key Responsibilities- Support the clinical study team(s) with the oversight of CROs and management of studies, including planning, execution, and close-out of clinical trials
- Assist with management of study-related vendors
- 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
- 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
- Review of data management aspects of clinical trials
- Support clinical operations functions during audits (e.g. BIMO, FDA)
- 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
- 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
- Perform QC of electronic Trial Master Files
- Fully understand the need for and importance of being inspection-ready and diligently follow Clinical Operations SOPs; take comprehensive and precise minutes for internal and external meetings
- 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
- Identify potential risks from study and site perspective and work with the CTM to assist in proactively resolving issues with CROs
- Participate in UAT for EDC/IRT
- Bachelor's degree in scientific, biological, life sciences, or related field
- Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management
- 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)
- Flexible approach to change
- State-of-the-art campus environment with on-campus restaurant and Montessori nursery
- Flexible working environment
- Competitive reward including annual company bonus
- 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.
