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Clinical Project Manager

Norwood, MA 02062

Post Date: 08/13/2018 Job ID: 2043 Job Category: Clinical: Clinical Operations and Development

The Clinical Project Manager is responsible for the successful execution of clinical trials from protocol conception through the clinical study report. The Clinical Project Manager ensures completion of study deliverables and proactively identifies and resolves clinical project issues.

Job Responsibilities:
  • Manages clinical operations aspects of clinical studies
  • Clinical Trial Overall:
    • Develop comprehensive study timelines and metrics
    • Develop and manage study budget within financial goals
    • Prepare and present project debriefings, as required; plan, execute, and lead or participate in study-specific meetings
  • Vendor Management:
    • Identify and assist in selection of external vendors required and the development of vendor specifications. Review and prepare vendor reports related to vendor proposals with recommendations
    • Assist in the selection and evaluation of study personnel (contract and internal)
    • Provide study-specific training and leadership to clinical research staff, and other contract personnel;
    • Manage study-related vendors and serve as the primary point of contact for contracted CROs, study staff and contract labs
    • Identify potential risks and resolve issues with CROs while establishing vendor management plans and reviewing quality metrics
  • Site Selection and Management:
    • Participate in site and country selection. Develop relationships with investigators and site staff.
    • Prepare and review site study documents: site-specific informed consent, study tools/worksheets, investigator contracts and site payments
    • Manage clinical monitoring activities, ensuring compliance with (GCP) and applicable regulations
    • Participate in site monitoring visits as appropriate
  • Uses operational and therapeutic expertise to optimize trial design and execution:
    • Design clinical trial protocols with study team consistent with clinical development plan
    • Develop ongoing data review plan to ensure data trend detection and study objectives are met
    • Prepare study-related documentation; provide input for the design of ICF template, CRFs, monitoring conventions, edit checks, etc.
    • Prepare and/or review study-related documents: Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual and CRF Completion Guidelines
    • Provide input and support documentation for adverse event safety monitoring while collaborating FDA and regulatory authorities report submissions
    • Coordinate with CMC or Clinical Supply to facilitate study drug manufacture, packaging, labeling and distribution
  • Ensures all clinical trial execution within compliance of international GCP guidelines/regulations and SOPs:
    • Participate in planning of QA activities and coordinate resolution of audit findings
    • Ensure audit-ready clinical trial documentation including central clinical files. Review monitoring reports, ensuring quality and resolution of site-related issues
    • Coordinate and assist regulatory or ethics committee activities planning
    • Provide staff oversight maintaining clinical trial master files to ensure appropriate compliance
  • Lead and consistently be present for the Cross-Functional Study Team as well as internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.)


Skills & Requirements:
  • Bachelor’ s Degree (health, biologic science or related field) required; Master’ s Degree preferred
  • Minimum of 5 years clinical study management experience in biopharmaceutical industry, including at least 2 years as a clinical study lead/project manager, required
  • Prior experience managing contracted resources/CRO required
  • Site monitoring and clinical data review highly preferred
  • Clinical quality compliance experience highly preferred
  • Advanced knowledge of GCP and current knowledge of CFR for IND clinical trials required
  • Knowledge of ICH and other country regulatory requirements is preferred
  • Excellent communication, organizational, problem-solving, conflict resolution, leadership and team-building skills required

Anna Korelis

Anna is a creative problem solver who prides herself on her strong work ethic and expert communication skills. Goal-oriented and service-driven, Anna has a keen eye for the skills that enable her candidates to stand out, and digs deep to understand what motivates them to find their next opportunity.

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