Director, Clinical Project Management Genocea Biosciences, Inc.
We are seeking a Clinical Project Manager to work closely with internal team members, CROs and vendors to ensure that assigned clinical trials are conducted per protocol, in a timely fashion and in a manner compliant with SOPs, ICH, GCP/regulatory guidelines, company goals and established budgets.
Prior study management experience on the sponsor side is a must
Strong study management track record showing clear proficiency in clinical project management skills. Solid vendor management skills. Broad understanding of study operations. Demonstrates detailed understanding of clinical protocols. Demonstrates ability to effectively interface with key medical personnel at clinical site(s). Demonstrates ability to lead multi-disciplinary teams. Possesses excellent written and oral communications skills. Knowledge of FDA, ICH, GCP/regulatory guidelines.
5 years of project management experience with clinical studies in a sponsor setting.
Participates in the selection of Investigators and vendors
Day to day oversight of multiple CROs
Develops and oversees study operational plan(s)
Supervises clinical study monitors/reviews monitoring reports
Monitoring of study progress including managing of timelines, draft and final project status reports
Responsible for developing and managing approved trial budget(s)
Occasional travel to CRO/vendor facilities to train and assess study teams
Assists with protocol design, strategy and medical issue resolution.
Participates in study data review and assists with patient narrative writing and other data review activities as assigned.
Contributes significantly to relevant study documentation including: clinical protocols, statistical analysis plan, clinical study reports, lab manuals, informed consents, etc.
Review of site invoices
Organizes and helps run team meetings
circulates agenda, solicits input from team in advance, takes meeting notes, circulates minutes, identifies issues and roadblocks
Maintains regular contact with key internal stakeholders
Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
Proactively identifies project risks and resolves with some supervision
May mentor more junior Clinical Operations Staff
Should have expert knowledge of Microsoft Project
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