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Clinical Project Manager (Science & Biotech)
Durham, NC 27703
Recruited by: Lori Steiner | Principal and Owner | NeedLS See all my Jobs

  • Hiring Company: NeedLS
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Jun 13, 2019
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Job Description

BASIC SUMMARY:
Manage all technical and administrative development and execution of clinical trials/protocols for multiple and complex projects. Execute Clinical Operations functions in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Coordinates clinical study organization, implementation and management with the Sponsor and PharPoint Research management personnel.
• Assists the Sponsor in writing laboratory specifications per study protocol and coordinating with lab vendors if necessary.
• Plans the preparation and execution of multiple clinical studies and assigns necessary responsibilities among appropriately qualified Project Team members, including the preparation of research documents and protocol monitoring guidelines.
• Reviews and approves all PharPoint Research and FDA regulatory documents required for the implementation, monitoring and evaluation of clinical trials, designing protocol-specific manuals, plans and documents as needed.
• Manages the identification and recruiting of investigator physicians and study sites and verification of qualifications and capabilities to successfully manage and conduct clinical studies.
• Manages and evaluates contracted services, such as central lab, IVRS, central IRB, drug distribution vendors, meeting planning services, etc.
• Conducts pre-study site visits, reviewing the accuracy of study initiation documents and coordinating the supply of study drugs, study and laboratory supplies, and file notebooks.
• Working with relevant project team members, provides PharPoint Research and Sponsor management projections on enrollment, CRF submission, study completion and other information as requested.
• Assumes primary responsibility for management of multiple project teams, ensuring the performance of all clinical monitoring duties according to FDA regulations and GCP, PharPoint Research SOPs, and any relevant study-specific Sponsor SOPs.
• Manages the fiscal performance of multiple studies through negotiation of investigator budgets, monitoring payments to investigators and contracted services, and maintaining close control over PharPoint Research study costs.
• Acts as principal liaison between Sponsor, Principal Investigator and PharPoint Research, providing timely information and maintaining a professional working relationship with all principals and related contractors and suppliers.
• Documents accountability, stability and storage conditions of clinical supplies and materials.
• Assists Quality Assurance by performing quality control audit procedures, including PharPoint Research and Investigator study files, and clinical review of collected data and clinical forms.
• Provides clinical support for Data Management by resolving any data queries and clarifying data entries as requested.
• Reviews all site and sponsor communications, including telephone contacts and trip reports.
• Submits timely and accurate project status reports as required by the Sponsor and PharPoint Research management and responds to and affects the expedient resolution of questions associated with the clinical study.
• Conducts a close-out inventory of clinical supplies and materials and coordinates the return shipment of unused materials per the Sponsors instructions.
• Participates in the preparation of a Clinical Summary report or Final Study Report.
• Provides field and/or in house training as part of career development for CRAs, including assisting in training progress assessment, and facilitate career development training for direct report employees.
• Responds to employees in a professional, timely and thorough manner using company resources as necessary.
• Supervises the employees of an assigned project team, conducting timely and thorough evaluation of work performance of all direct report personnel.
• Maintains compliance with all policies, procedures of the company, including security and safety.
• Routinely stays abreast of GCP, updated guidance from FDA as it relates to clinical research, as well as current clinical related developments in the assigned therapeutic areas.
• Other related projects and activities as assigned.
QUALIFICATIONS:
• Education: Bachelor’s degree (B.A./B.S.) or equivalent in a health sciences field.
• Experience: 6 years experience in clinical trials management or related field. 3 years supervisory experience in a clinical research environment.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: Certification with a professional industry organization is desired.
• Other: Comprehensive and demonstrated knowledge of coordination and management of large projects and multiple simultaneous projects. Understanding of clinical related applications in assigned therapeutic area. Demonstrated professional oral and written communication, technical training, and employee relations management skill. Ability to read, write, speak and understand English required.