Clinical Operations Manager at Neon Therapeutics
Cambridge, MA, US
Position Summary

The primary role of this position within Neon Therapeutics clinical operations team is to ensure all trial deliverables are met according to timelines, budget, operational procedures and quality standards (e.g., GCP, ICH and Neon Therapeutics standards). This includes responsibilities associated with planning, start-up, maintenance and closeout of clinical trials.

Responsibilities include but are not limited to:

Support the clinical protocol development process in collaboration with the Head of Clinical Operation and the Medical Mentor: 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 relationships 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
Participate in process improvement projects (as necessary)
Experience and essential skills

B.A./B.S. degree required
A successful candidate should have a minimum of 4 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), organization and interpersonal skills
Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously