Sr. Clinical Study Manager in Burlington, MA at Apex Life Sciences

Date Posted: 5/30/2018

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Job Description

The Sr. Clinical Study Manager coordinates various multi-disciplinary teams to meet clinical trial objectives.  With the goals for the development program in mind, provides substantive contributions to the strategic design and execution of a clinical trials program.  The Sr. Clinical Study Manager continuously evaluates the progression, quality, and cost of the various operational steps involved in planning and execution of a clinical program.  

Responsible for planning, scheduling and implementing all functional activities, and the overall coordination and management of Phase II-III clinical trials from start up through to clinical study report
Responsible for primary interactions with internal and external cross functional teams and key stakeholders, and ensuring study objectives are met
Development of clinical project plans, study budgets and timelines, and communicates project status and issues
Tracks Clinical Operations project deliverables using appropriate tools
Responsible for development of RFPs, the assessment and selection of CROs/vendors
Oversees the day-to-day activities of CROs/vendors (across all functions) by serving as primary contact point, addressing questions and resolving issues
Responsible for writing, and coordinating the review of key study documents, including protocols, informed consents, case report forms, monitoring plans and clinical study reports
Coordinates all regulatory and REC/IRB associated activities
Coordination of audits and preparing and responding to CAPAs
Updating SOPs and review of clinical operations processes
Responsible for risk mitigation strategies, associated action plan and issue resolution
Conducts Monitoring/co-monitoring as required
Provides support and training for other staff members on specific areas of expertise
Prepares and presents at Investigator Meetings and other external conferences
Contributes to Clinical Operations team activities & initiatives

Bachelor’s degree in life science, medical or related field
8+ years of relevant industry experience (sponsor and CRO)
7 years of clinical research experience including byt not limited to CRO oversight working on Phase I to III pharmaceutical clinical studies.
Experience in cardiovascular, ophthalmology or oncology therapeutic areas is desirable
Travel: up to 25% (Including some international)


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.