Clinical Trial Manager
7 days ago
We are seeking a highly skilled Clinical Trial Manager to join our team at Bicycle Therapeutics. As a Clinical Trial Manager, you will play a crucial role in planning, implementing, and overseeing our clinical trials.
Key Responsibilities:- Lead cross-functional clinical study teams to ensure successful trial implementation and protocol execution.
- Manage and oversee activities at CROs and other clinical vendors, monitoring status and providing real-time updates to the program team.
- Ensure all study activities are completed in accordance with country-specific ICH GCP, health authority regulations, and company SOPs.
- Responsible for ongoing study communication and escalation of study-related issues as required.
- Contribute to the writing and development of clinical documents, such as protocols, informed consent forms, investigator brochures, project plans, pharmacy manuals, study reports, and annual reports.
- Ensure the TMF is set up and maintained appropriately throughout the trial, including periodic reviews.
- Develop and maintain tracking tools for the Clinical Operations teams throughout the trials.
- Review data management aspects of clinical trials.
- Support clinical operations functions during audits, such as BIMO and FDA.
- Participate in the review and approval of clinical monitoring visit reports in conjunction with the CTA.
- Establish and maintain daily contact with the CRO counterpart, reviewing and identifying potential issues or problems with sites and communicating/escalating to the CTM or senior Clinical Operations staff.
- Fully understand the need for and importance of being inspection-ready and diligently follow Clinical Operations SOPs, identifying and communicating any gaps.
- Assist the CRO with planning investigator meetings and associated travel.
- 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 perspectives and work with the team to assist in proactively resolving issues with CROs.
- Participate in UAT for EDC/IRT.
- May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
- Familiarity with ICH, GCP, and FDA requirements, as applicable, for clinical trial management.
- Strong organizational skills and enjoyment of 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.
Additional Information:
- State-of-the-art campus environment with on-campus restaurant and Montessori nursery.
- Flexible working environment.
- Competitive rewards, including an annual company bonus.
- Employee recognition schemes.
- 28 days annual leave, in addition to bank holidays, with the 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.
- 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. We recognize that diverse and inclusive teams build a stronger and more innovative company. 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.
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