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Clinical Project Manager

Company: Beacon Hill Staffing Group - Pharma
Location: Burlington
Posted on: March 14, 2020

Job Description:

Principal Responsibilities and Accountabilities: 1. Accountable for leading the internal Study Execution Team; lead study specific decision making, develop strategies for increasing study efficiencies and coordinate issue detection, resolution and, where necessary, escalation. 2. Ensure that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensure that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by the CRO. 3. Reponsible for providing oversight of the CRO to ensure contract and budget performance and compliance with the Companys quality metrics by focusing on proactive risk identification and management. 4. Drive synopsis and protocol writing, and oversee clinical study report writing in collaboration with other members of the clinical team; review study documents including ICF, CRF, study plans, data capture systems and data reviews/data review meetings, and all materials supporting enrollment, recruitment, and retention. 5. Identify issues/gaps in processes and interfaces with other groups and departments and contribute to developing recommendations for resolution. Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and partner CROs. 6. Follow established clinical study standards and procedures (ICH and GCP) according to quality systems and regulatory requirements, ensuring studies are delivered with quality. 7. Perform other duties as may be assigned from time to time. Qualifications: 1. Education: BS in public health, science, or a related discipline required. MS or MBA preferred. 2. Experience: 5-7 plus years of clinical study management experience in biotechnology or pharmaceutical industries, including team leadership. Knowledge of GCP and ICH required. Knowledge in clinical trial protocols for Phase 1 through Phase 3, and NDA submission experience preferred. Expertise in dermatology, womens health, gastroenterology, anti-inflammatory, and virology therapeutic areas highly desirable. Practical experience with proactive, risk based management, EDC systems, statistical analysis plans, and electronic trial master files. 3. Skills: Clinical trial management and team leadership (ideally CRO and sponsor) Excellent time management and organizational skills Solution based management with root cause analysis skills Ability and willingness to identify issues, manage or escalate appropriately and implement correction Ability to manage multiple priorities in a fast-paced work environment Strong interpersonal skills with the ability to negotiate to timely deliverables from cross-functional team members or vendors Motivation, mentoring, and integration of individuals on cross-functional teams or vendors 4. Technical knowledge: GCP and regulatory environment Medical knowledge and research expertise Basic principles of data management and statistics Excellent verbal and written communication in English Development of scientific/medical presentations for both large and small audiences Proficiency in the Microsoft Office suite

Keywords: Beacon Hill Staffing Group - Pharma, Burlington , Clinical Project Manager, Healthcare , Burlington, North Carolina

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