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Senior Associate, Data Management
2 months ago
Job Title: Senior Associate, Data Management
Job Summary:
Bicycle Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Associate, Data Management to join our team and contribute to the success of our clinical study programs.
Key Responsibilities:
- Support the clinical study team in overseeing Contract Research Organizations (CROs) and managing studies, including planning, execution, and close-out of clinical trials.
- Assist the Clinical Trial Manager in preparing study documents, such as protocols, informed consent forms, and investigator brochures, and track revisions.
- Perform lab sample tracking using the central lab database.
- Review data management aspects of clinical trials.
- Participate in the review and approval of clinical monitoring visit reports in conjunction with the CTM and track outstanding follow-up items as requested.
- Perform quality control of electronic Trial Master Files.
- Understand the importance of being inspection-ready and follow Clinical Operations SOPs.
- 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, such as contracts and licenses.
- Identify potential risks from study and site perspectives and work with the CTM to proactively resolve issues with CROs.
- Participate in User Acceptance Testing (UAT) for Electronic Data Capture (EDC) and Interactive Response Technology (IRT) systems.
Requirements:
- Bachelor's degree in a scientific, biological, or life sciences field.
- Familiarity with ICG, GCP, and FDA requirements for clinical trial management.
- Attention to detail and quality.
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint).
- Flexible approach to change.
What We Offer:
- A state-of-the-art campus environment with on-campus amenities.
- A flexible working environment.
- Competitive rewards, including an annual company bonus.
- Employee recognition schemes.
- 28 days of annual leave, plus bank holidays, with the option to purchase additional days.
- Employer contribution to pension.
- Life assurance cover.
- Private medical insurance, including optical and dental cover.
- Enhanced parental leave policies.
- 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.
Equal Opportunities:
Bicycle Therapeutics is committed to building a diverse workforce that reflects the communities we serve. We welcome applications from all qualified candidates and do not discriminate on the basis of race, religion, color, gender, sexual orientation, age, disability status, marital status, or veteran status.