Manager, Trial Master File Operations - Bicycle Therapeutics

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA USA.

Culture is key and all Bicycle employees actively embrace and role model our company values:

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination
• We are One Team. We only succeed when we work together.

We are looking for a Manager, Trial Master File Operations, who will be responsible for the oversight of projects for TMF Technology within the Clinical Operations group. In this role they function as the subject matter expert to support the selection, implementation, and ongoing management of an in-house electronic Trial Master File (eTMF) solution and future innovations.

The right candidate will collaborate closely with stakeholders to integrate the selected eTMF system within the Regulatory Information Management (RIM) and Document Management Systems.

The right candidate will possess expertise in eTMF applications and technology. The TMF manager will provide expert guidance on eTMF filings that align with ICH/GCP Guidelines. They will work with internal and external stakeholders to ensure that documents added into the eTMF system meet regulatory standards and internal processes. They will develop and ensure training with Stakeholders that comply with these standards and processes.

This role will have will require collaboration with cross functional teams (e.g, clinical operations study team members, regulatory affairs, quality assurance, and information technology) to ensure TMF compliance and quality)

This role will manage the oversight of the CRO in doing quality checks and archiving of eTMF data for legacy studies that are not in the Bicycle’s eTMF system.

The position will be a member of the Clinical Operations group, reporting to the Director, Clinical Outsourcing and Business Operations.

• Subject Matter Expert on eTMF processes and in the Trial Master File reference model
• Day to day management of TMF files for their respective studies including upload, review, and approval of the TMF documents.
• Manage the Trial Master file in compliance with regulatory requirements and company SOPs.
• Implement and manage TMF documents such as TMF plan, indexes, and other guidance documents or processes as assigned.
• Develop and provide training to clinical trial teams and external stakeholders on the eTMF system and procedures.
• Collaborate regularly with GCP Quality Assurance in developing processes and strategies.
• Partner with Study assigned team members for timely, consistent, and quality set up and maintenance of TMF requirements and processes, including user access, document QC, upload remediation and query management.
• Ensure completeness, accuracy, and timeliness of the TMF documentation.
• Partner with the external and internal stakeholders to conduct quality checks of the TMF for Inspection readiness with the goal of compliance with the regulations.
• Provide inspection readiness support by driving TMF quality reviews for preparations inspections and audits.
• Identify appropriate metrics and KPIs and develop process improvements to enhance compliance within the eTMF system.
• Continuously evaluate and enhance TMF processes and workflows to optimize efficiency and compliance.

• Minimum Education Required: Bachelor’s degree in scientific discipline preferred
• The candidate should ideally have at least 3 years of eTMF experience at a Sponsor company or CRO managing various TMF systems that include clinical trials in different clinical phases (e.g., Phase 1 -Phase IV)
• Familiarity with regulatory requirements (e.g, ICH-GCP, global regulatory agencies requirements
• Good Organization skills and attention to detail
• Excellent written and oral communication skills
• Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint)
• Flexible approach to change

• 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.

All your information will be kept confidential according to EEO guidelines.

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.