Clinical Operations Associate*
- Cambridge (Boston)
- Junior, Career start
- Research, development, teaching
Clinical Operations Assistant*
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 searching for a Clinical Operations Assistant who will be tasked with ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards (e.g., GCP, ICH and Company standards). Additional responsibilities include planning, start-up, maintenance and closeout of clinical trials.
Here, you’ll achieve greatness.
- Assist in development of study tools, guidelines, and training materials to support effective and accurate execution of clinical trial activities
- Ongoing management of trial allocations forms
- Maintain site, vendor, team and other contact lists as applicable
- Set up and maintain Trial Master File (TMF)
- Attend and provide support in meeting scheduling and distribution of meeting agendas/minutes
- Take lead in logistical aspects of Investigator Meeting planning
- Review all site level Informed Consents (ICFs). Complete and file ICF checklists
- Review all site regulatory packages during study start-up to approve for Investigational Product release
- Assist with data monitoring such as tracking of SAEs and protocol deviations
- Provide support in reviewing study documents (e.g., site ICFs, IBs, protocols, regulatory documents, SIV slides, etc.) to ensure quality and consistency according to quality standards
- Assist with the management of tracking, logistics and quality operations for biological samples supporting clinical trials from collection to analysis to help ensure that sample inventories are accurate, complete, and up-to-date
- Communicate with management and clinical trial teams to ensure transparency throughout the course of the trial(s) regarding study metrics and overall status
- Participate in process improvement projects (as necessary)
What you have to offer.
- BA/BS degree required
- 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 email@example.com.
*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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