Company Description 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.
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.