Senior Clinical Trial Manager/Associate Director, Clinical Operations

Clinical Operations Cambridge, Massachusetts


Description

What’s in it for you?

We have an exciting opportunity for a highly motivated individual to help guide the operationalization of the clinical strategy for Mersana’s drug development programs. You will mentor colleagues with less experience and ensure study performance and efficiency of processes. This is an opportunity to make a visible impact through your strategic and scientific input as you use your knowledge of and experience with executional excellence to help build clinical expertise on the team and drive the development of our assets. This position reports to the Director, Clinical Operations.

 

How do you know if you’re the right fit?

Excellent and timely communication skills are essential elements of success in this position. The ability to work in a fast-paced environment and hold groups and individuals accountable to their incremental and program-level deliverables, goals, and objectives is a key performance expectation for this position. Your leadership style should be strongly oriented to leading by example and influence. Your past experience, and current skill set will continue to the following:

  • Planning, coordinating, and overseeing clinical study set-up, active study management, data analysis and reporting, and close-down for one or more clinical studies.
    • Creating and managing 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 supplies 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.
    • Providing in-depth, substantive review and comment on all clinical study guidance documents, including, but not limited to: clinical elements of the Investigator Brochure, DSUR, 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.
    • Attending Clinical Sub-team meetings directly related to program oversight and strategic development of trials
    • Liaising with IRBs/IECs or other patient safety boards, ensuring timely original submissions and resolution of any issues.
    • Preparing and delivering study team protocol-specific training materials.
    • Oversight of Investigator grant payment set-up and payments.
    • Study budget oversight for assigned clinical trials
    • 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-monitoring with and without CRO to ensure adherence to protocol and monitoring standards.
    • Reviewing monitoring trip reports for compliance issues and trends.
    • Providing detailed review of all interim and final clinical study data outputs.
    • Conducting all activities in compliance with Mersana and CRO SOPs and other regulatory guidance documents.
    • Performing other activities as assigned.


The other stuff

This is typically a role best suited for a MS/MA/MBA and bachelor’s degree in science- or health care-related field with at least 4 years working in the biopharma industry. 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. Additionally, best fit candidates will demonstrate:

  • Expertise in process development and management, and GXP remediation.
  • Proven track record of success in managing global clinical studies from set-up through data reporting in Phases 1 through 3.
  • 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 and management.
  • 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 guidance 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.

Title and compensation are commensurate with experience and level of responsibility.

Occasional planned and overnight travel, up to approximately 15% per annum.  


Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation and paid holidays.

Successful candidate must be authorized to work in the United States. Mersana Therapeutics, Inc. is an equal opportunity employer.