Senior Clinical Trial Manager*
- Cambridge (Boston)
- Work experience
- Research, development, teaching
Senior Clinical Trial Manager*
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
BioNTech US and the Clinical Operations team is looking to identify a Senior Clinical Trial Manager who will be responsible for ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards (e.g., GCP, ICH and Company standards). Additional key responsibilities include the planning, start-up, maintenance and closeout of clinical trials.
***Please note this job is based in Cambridge, MA and is an office/home-based position so candidates outside the local area must relocate should they be hired into the position.
Here, you’ll achieve greatness.
- Support the clinical protocol development process in collaboration with the Head of Clinical Operations and the Medical Monitor: Contribute in the development of clinical protocols, amendments and related documents; drive and/or contribute to the development of trial-related documents and processes
- Lead the development of study tools, guidelines, and training materials to support effective and accurate execution of clinical trial activities
- Develop relationship with Investigators and Site Staff as primary contact for clinical conduct of the trial
- Under the guidance of the Head of Clinical Operations, manage study start-up activities including regulatory documents, budget, and clinical trial agreements
- Participate in the ongoing review and cleaning of the clinical trial data
- Chair study team meetings, collecting input from all functional lines
- Participate in site identification; attending PSVs and SIVs as necessary
- Assist in the management of 3rd party vendors; including CRO, central lab and imaging vendors
- Manage tracking, logistics and quality operations for biological samples supporting clinical trials from collection to analysis ensuring that sample inventories are accurate, complete, and up-to-date through effective interactions with internal teams, sites, central reference labs, specialty lab partners, external collaborators (e.g. Academia) and third-party vendors
- Ongoing management of accurate enrollment log/trial allocations forms
- Ensure compliance with patient consent for collection and intended use, destruction, storage and/or future, post-study use of biological samples
- Communicate with management to ensure transparency throughout the course of the trial(s) regarding study metrics and overall status
What you have to offer.
- BA/BS degree required
- Minimum of 8-10 years of experience in clinical drug development or clinical trial execution with exposure to biomarkers or immunogenicity sample activities including sample collection procedures and logistics considerations
- Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems
- Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues
- Excellent teamwork, communication (verbal and written), organizational, and interpersonal skills
- Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email firstname.lastname@example.org.
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
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