Location: Newton, MA
Primary Job Responsibilities:
The Clinical Project Manager is responsible for the planning, implementation and conduct of clinical trials across indications or development compound(s). The CPM is expected to provide leadership within the Clinical Operations department and make recommendations with regards to the strategic aspects of clinical programs.
- Displays highly developed project leadership qualities.
- Deep understanding of Clinical Operations and Drug Development.
- Expert on assigned protocols. Demonstrates ability to integrate and summarize medical/scientific concepts in protocols and other documents. Proactively seeks out and recommends process improvements.
- Proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight.
- Communicates clearly and effectively with internal and external key stakeholders.
- May contribute to Clinical Development Plans with some oversight.
- Consistently demonstrates overall leadership in Clinical Operations.
- Develops study budget(s) with oversight.
- Attends scientific meetings and builds relationships with Investigators, business partners.
- Participates in study data review and interpretation.
- Assumes a role in the identification process of Investigators or vendors and assures proper prequalification of clinical sites.
- Ensures external and internal documentation prepared within the Clinical Operations function is completed in accordance with GCP regulatory requirements and consistent with the protocol, for all assigned programs/trials.
- Proficient in Microsoft Office applications (PowerPoint, Microsoft Word, Microsoft Excel, etc.), Internet software, E-mail
- Experience with Electronic Data Capture (EDC) systemsQualifications:
- B.S. /B.A. or advanced degree in a scientific or allied health field and at least 5 years of work experience in the Biotech or Pharmaceutical Industry.