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Categories: Pharmaceutical
General Summary
Primary responsibility of this position is the initiation and execution of clinical trials that support the business objectives of the venture, both internally and through a CRO. Works under general direction of the Manager, Clinical Operations.
Principal Duties and Responsibilities (essential functions)
The Clinical Project Manager:
assists in developing and managing project timelines.
ensures clinical studies are sufficiently resourced and executed in accordance with project timelines.
assists in the development of study protocols by coordinating input from various sources: literature, experts, and internal team members.
reviews Investigator qualifications and performs Site Evaluation Visits for potential study sites, documenting results and recommendations.
secures consultant and vendor contracts as needed
implements clinical studies with the CRO, defining and tracking deliverables.
performs as the primary day-to-day contact with the CRO, study coordinators, and other study vendors as required.
maintains internal study documentation files.
tracks invoices/POs for periodic financial reporting
Requirements:
Education and/or Experience
Minimum of Bachelors degree, preferably in Biological Science, or RN
Minimum 2 years Clinical Project Management experience
Minimum 4 years CRA experience
Medical Device experience preferred
Therapeutic knowledge/experience in urology and/or neurostimulation a plus
Other Required Skills and Abilities
Knowledgeable in GCP guidelines, and FDA/ICH regulations, especially 21CFR 50, 54, 56, and 812.
Skilled in protocol, informed consent, and CRF development
Experienced in study initiation and execution, data management (including EDC), and CRO oversight. Global study experience a plus
Flexibility with changing priorities in a venture environment
Ability to work independently, and as part of a team
Detail-oriented and exceptional organizational ability
Excellent written and verbal communication skills
NumberOfPositions: 1
Minimum Education: 4-Year College Degree
Career Focus 1: Science/Biotech
Career Focus 2: Healthcare/Medical |
