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Clinical Project Manager - AD, Clinical Project Management

Cambridge, MA

Posted: 03/04/2019 Job Category: Clinical: Clinical Operations and Development Job Number: 2136

Clinical Project Manager

Our client is seeking a Clinical Project Manager to add to their growing Oncology team working on a robust pipeline. Reporting to the Director of Clinical Operations, they are looking for a candidate that has experience as a CRA or CTA and looking to make a move as a CPM. This person can be someone without direct CPM experience. They would prefer an up and comer who is eager to learn and expand their Oncology career.

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
  • 2-3 years of clinical study management experience in biopharmaceutical industry, including at least 1-2 years as a CRA or Sr. CTA
  • 1 year of Oncology experience required
  • Excellent communication, organizational, problem-solving, conflict resolution, leadership and team-building skills

Nice to Have’ s:
  • Prior experience managing contracted resources/CRO
  • Site monitoring and clinical data review
  • Clinical quality compliance experience
  • Knowledge of GCP and current knowledge of CFR for IND clinical trials
  • Knowledge of ICH and other country regulatory requirements

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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