Senior Manager, Clinical Operations

Proclinical is currently recruiting for a Senior Manager of Global Clinical Operations with an emerging biotechnology company located in the Triangle Area, NC. As the Senior Manager, you will be responsible for being the primary manager of clinical study protocols, responsible for ensuring trial objectives, including compliance with Good Clinical Practice (GCP) regulations/guidelines, the protocol and relevant SOPs, timelines, and budget are executed on time.

Job Responsibilities:

• Oversight or direct management of the day-to-day clinical operations, including management of vendors (e.g., CRO) and coordination of activities
• Track and prepare study-specific information utilizing databases, spreadsheets and other tools
• Be accountable for all trial deliverables
• Reporting of trial progress to management team
• Contribute to study documents such as the protocol, amendments to the protocol, informed consent forms (ICFs), case report forms (CRFs), clinical study reports (CSRs), Investigational New Drug Application (IND) annual reports, Periodic Safety Update Reports (PSUR), Investigator's Brochure (IB) and New Drug Application (NDA)
• Maintains and manages internal clinical trial files and documents
• Assist in the identification and management third party vendors, including development of Request for Proposals (RFPs), scope of work (SOW), and vendor specifications documents
• Ensure that CRO and Investigators are aware of their Serious Adverse Event/Serious Adverse Drug Reaction reporting obligations
• Oversee investigator and site study payments
• Participates in investigator meetings and follow up
• Coordinates and plans for the availability of non-clinical supplies necessary to meet study requirements
• Travel to sites when necessary, including international travel.
• Ensure Investigational Product (IP) needs for clinical studies are available and managed appropriately.
• Coordinate activities related to audit findings and/or identification of significant site noncompliance

Skills and Requirements:

• The candidate must have a BA/BS degree or equivalent; health science degree or biologic science degree is preferred. A minimum of 5-8 years' experience in the pharmaceutical industry, with minimum 5 years direct experience in planning and managing clinical trials.

• The candidate should have significant experience with responsible roles in the conduct or management of Phase I - III clinical trials.
• The candidate must have a good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S., international regulations and guidelines, is preferred, but not required.
• Excellent oral and written communication, organizational and planning skills are required, ideally with the ability to manage budgets.
• The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

If you are having difficulty in applying or if you have any questions, please contact Matthew Pike at m.pike@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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