Senior Clinical Trial Manager

Company: Mersana Therapeutics, Inc
Location: Cambridge
Posted on: February 25, 2021

Job Description:

Clinical Operations Cambridge, Massachusetts

• Daily management of CRO and vendor study team staff to ensure activities align with study goals and applicable SOPs and regulatory
• Assist with planning and coordinate and oversee clinical study start-up, study conduct, data cleaning, and close-down.
• Provide in-depth review and comment on all clinical study guidance documents, including, but not limited to clinical elements of the protocol, ICF template. Provide input and manage the completion of various clinical study plans, e.g., study manual, monitoring plan, data, regulatory reporting plan.
• Provide clinical document appendices for CSR.
• Serve as the trial Subject Mater Expert for the Data Management team regard timely DCF processing and follow-through. Provide critical review of DMP and associated
• Maintain study timelines and provide regular reports on planned versus actual milestone
• Identify potential clinical study risks and work cross functionally to implement effective preventative and mitigation
• Sponsor liaison through CRO with IRBs/IECs or other patient safety boards, ensuring timely submissions and resolution of any
• Prepare and deliver study team protocol-specific training
• Manage the study in line with the approved study budget and executed CRO/vendor agreements.
• Oversight of
• Support the general oversight and periodically provide direct management of clinical Trial Master File at CRO, ensuring currency and timely, accurate final transfer from
• Co-monitor with and without CRO to ensure adherence to protocol and monitoring
• Review monitoring trip reports for compliance issues and
• Oversee research site CAPAs regarding study execution. Perform site remediation training as needed and/or provide remediation
• Conduct all activities with compliance to Mersana and CRO SOPs and other regulatory
• May conduct these activities for one or more studies 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 bachelors' degree with more than 7 years of clinical research
  • Project Management Professional certification is beneficial along with experience as a CRA and/or Data
  • Experience in process development and management, and GXP
  • Proven track record of success in managing clinical studies in the U.S. from set-up through data reporting in Phase 1/2. 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
  • Experience managing less experienced clinical operations personnel (internal and/or employees of a vendor partner) in an equitable, direct, and collegial
  • 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
  • Working understanding of FDA and ICH GCP regulations and guidance that directly apply to clinical trial conduct, clinical data management, and clinical study
  • Prior experience managing oncology trials is preferred. Prior clinical work with ADCs is a
  • Occasional planned and overnight travel, up to approximately 15% per Title and compensation are commensurate with experience and level of responsibility. Position is eligible for bonus, option awards, and benefits including medical, dental and life insurance, 401(k) with employer match, vacation, and paid holidays. Candidate must be authorized to work within the US. Mersana is an Equal Opportunity Employer. You have been redirected to a Mersana Therapeutics, Inc. job page

Keywords: Mersana Therapeutics, Inc, Cambridge , Senior Clinical Trial Manager, Executive , Cambridge, Massachusetts