Clinical Trial Manager
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 drive the development of our assets. This position reports to a Senior Clinical Trial Manager (SCTM) in 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 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 experience and current skill set will include to the following:
- Manage a portion of the following aspects of a larger, international study under the guidance of a Senior CTM.
- Daily management of CRO and vendor study team staff to ensure activities align with study goals and applicable SOPs and regulatory guidelines.
- Plan, coordinate, and oversee clinical study start-up, study conduct, data analysis, reporting, and close-down.
- Provide 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, monitoring plan, data management plan, regulatory plan, safety plan, statistical analysis plan. Provide same for CSR.
- Coordination with internal project team members to ensure all required disciplines are aligned to support all phases of the clinical trial.
- Maintain study timelines and provide regular reports on planned versus actual milestone status.
- Identify potential study risks and work cross functionally to implement effective preventative and mitigation strategies.
- Sponsor liaison with IRBs/IECs or other patient safety boards, ensuring timely submissions and resolution of any issues.
- Prepare and deliver study team protocol-specific training materials.
- Manage the study in line with the approved study budget and executed CRO/vendor agreements.
- 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.
- Review 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.
- May conduct these activities for one or more studies simultaneously.
- An MS/MA/MBA or bachelor’s degree in science- or health care-related field with at least 3 years of clinical research experience OR a bachelors’ degree with more than 4 years of clinical research experience.
- Project Management Professional certification is beneficial along with experience as a CRA and/or Data Manager.
- Experience 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 1/2. 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 guidance that directly apply to clinical trial conduct, clinical data management, and clinical study reporting.
- Prior experience managing oncology trials is preferred. Prior clinical work with ADCs is a plus.
- Occasional planned and overnight travel, up to approximately 15% per annum.
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.