Job Description

We are looking for a Trial Master File (TMF) Specialist to support our growing TMF Operations Department.

The right candidate will have experience in TMF study management. They will work with Bicycle study teams and with our CRO partners to ensure that our eTMF is inspection ready throughout the conduct of the study.

This role will support oversight of TMF activities, including TMF Health and quality management. They will work with internal and external study teams to ensure that Bicycle eTMFs are complete and comply with regulatory standards and governing SOPs.

This position will be a member of the Clinical Operations group, reporting to the Manager, Trial Master File Operations.

• Contribute to process improvement initiatives for clinical document management and clinical trial records (e.g., Trial Master Files).
• Review and update study specific TMF Plans and Indexes based on feedback received from leads to ensure all information is accurate and current.
• Support the development of TMF metrics and KPIs related to inspection readiness
• Perform completeness and quality reviews of internal and CRO managed eTMFs
• Perform oversight check of QC reviews performed by sponsor and CRO team members
• Identify and escalate quality issue trends
• Provide internal and external study team members with relevant reports to support TMF Quality
• Represent TMF Operations function in internal and external study team meetings
• File documents as needed in the eTMF and support QC and query management
• Assist with ‘Go Live’ activities and study management activities associated with sponsor implementation of document management technologies (e.g., UAT testing, user training, document approval, query management etc.)
• Other activities as assigned, including supporting inspection readiness activities within Clinical Development to help meet timelines and objectives.

Qualifications

Essential:

• Experience with electronic trial master file eTMF systems and advanced understanding of eTMF system functionality, document workflows and navigation
• Prior experience in a clinical operations role (e.g., CTA, CRA, TMF Operations role) or in clinical quality assurance (e.g., GCP auditor)
• Solid understanding of the clinical trial process.
• In-depth knowledge of TMF Reference Model (CDISC)
• Knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process
• Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint)
• Must be able to collaborate with internal functions as well as CRO counterparts.
• Proven ability to manage multiple studies, meet study timelines, while also maintaining an expectation of quality work
• Strong communication, presentation and writing skills

Desirable:

• UAT testing and TMF system implementation
• Experience with other clinical systems (e.g., CTMS, RIM).
• Strong understanding of EDLs and milestone management
• eTMF administrative and analyst experience (e.g., study and site set-up, user access and permission control, system troubleshooting etc.)
• Experience drafting TMF documents such as TMF plans, indexes, and other guidance documents or processes
• Supported regulatory (e.g., FDA, MHRA, EMA etc.) inspections or helped with pre-inspection prep activities.
• Prior experience working in Veeva or ClinTrak eTMF management platforms

Additional Information

• Flexible working environment
• Competitive reward including annual company bonus
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
• Health and Dependent Care Flexible Spending Accounts
• 401(k) plan with a 4% Company match and immediate vesting
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
• Employee assistance program
• Employee recognition schemes
• 10 Company holidays
• Competitive Family Leave Policy
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

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, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.