Senior Clinical Program Manager / Associate Director (AD)

  • Cambridge, MA
  • Permanent
  • Full-time
  • 1 month ago
Provide in-depth, substantive review and comment on all clinical study guidance documents, including, but not limited to: clinical elements of the Investigator Brochure, protocol, ICF, and the various study plans, e.g., study manual, data management plan, regulatory plan, safety plan, statistical analysis plan. Provide same for CSR.
Plan, coordinate, and oversee clinical study set-up, active study management, data analysis and reporting, and close-down.
Create and manage clinical study timelines, ensuring performance to plan within a fully out-sourced model via:
Management of CRO and other vendor partners required for study conduct, e.g., clinical trial material labeling and distribution; central and local laboratories, enrollment and patient out-reach.
Coordination with internal project team members to ensure all required disciplines are aligned to support all phases of the clinical trial.
Main Sponsor liaison with IRBs/IECs or other patient safety boards, ensuring timely original submissions and resolution of any issues.
Prepare and deliver study team protocol-specific training materials.
Investigator grant payment set-up and oversight of payments.
General oversight and periodic direct management of clinical Trial Master File at CRO and at Mersana, ensuring currency and timely, accurate final transfer from CRO.
Co-monitor with and without CRO to ensure adherence to protocol and monitoring standards.
Surveil monitoring trip reports for compliance issues and trends.
Detailed review of all interim and final clinical study data outputs.
Conduct all activities with compliance to Mersana and CRO SOPs and other regulatory guidance documents.
Conduct these activities for more than one study simultaneously.

Requirements:

An MS/MA/MBA or bachelor’s degree in science- or health care-related field with at least 4 years of clinical research experience. Or, a BS in the same areas with more than 7 years of clinical research experience. Project Management Professional certification is beneficial along with experience as a CRA and/or Data Manager.
Expertise in process development and management, and GXP remediation.
Proven track record of success in managing clinical studies in the U.S. from set-up through data reporting in Phase 1 and 2. Experience with Phase 3 studies and running studies in ex-US settings is preferred.
Strong interpersonal skills; ability to collaborate and communicate across disciplines with excellent and timely written and oral skills.
Experience managing less experienced clinical operations personnel (internal and/or employees of a vendor partner) in an equitable, direct, and collegial manner.
Ability to coordinate current activities with long-range plans and effectively apply lessons- learned.
Experience with clinical budget forecasting.
Ability to think analytically, identify problems as they are occurring (proactive management), and rapidly identify and implement solutions that are GCP compliant.
Working understanding of FDA and ICH GCP regulations and guidances that directly apply to clinical trial conduct, clinical data management, and clinical study reporting.
Prior experience managing oncology trials. Prior clinical work with ADCs is a plus.
Occasional planned and overnight travel, up to approximately 15% per annum.

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