Senior Clinical Trial Manager
Company: Mersana Therapeutics, Inc
Posted on: February 25, 2021
Clinical Operations Cambridge, Massachusetts
- Daily management of CRO and vendor study team staff to ensure
activities align with study goals and applicable SOPs and
- 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
- Sponsor liaison through CRO with IRBs/IECs or other patient
safety boards, ensuring timely submissions and resolution of
- 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
- 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
- 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
- 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
- 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
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