Location
Cambridge, MA | United States
Job description
The Clinical Trial Manager leads the planning, implementation and execution of complex clinical study protocols, operational plans and study timelines, in alignment with study/program goals and strategic objectives. Managing all aspects of study progress (from protocol development and planning to study close-out, including supporting the development of clinical study reports), the Sr. CTM assures adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP, and ICH guidelines. This role drives collaborative and effective management of cross-functional study team activities, as well as communication with and management of multiple external vendors and stakeholders (e.g., CROs, central labs, IRBs/ECs, and other external partners). S/he proactively identifies, manages and communicates risks to key stakeholders and is also in communication and closely integrated with clinical trial sites, promoting relationship development with team members, stakeholders, Investigators and site staff.
Key Responsibilities:
Leadership and Vendor Management
Drives the activities of the Clinical Trial Working Group, a cross-company and cross-functional team, as it relates to complex, global, study-level strategies, timelines, goals, and quality
Acts as ad hoc member of the Development Sub-Team to establish operational effectiveness in program-level development of clinical strategies, goal-setting, and establishment of timelines
Evaluates, selects and ensures appropriate oversight of Contract Research Organizations (CROs) and other external vendors. Builds strong partnerships with key counterparts at CRO(s) and other external vendors
Communicates with clinical trial sites as appropriate to ensure optimal Sponsor-Site relationships
Communicates trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities, and deliverables
Guides the development of study-level and program budget(s) and demonstrates accountability for the management of assigned clinical study budget(s):
Tracking vendor performance against scopes of work, contracts, and invoices to ensure consistency between work performed and contractual agreement(s)
Facilitating review of study-level scopes of work, invoices, change request forms, and change orders to ensure consistency with study progress and/or evolving study needs
Participates in partnership (e.g. Celgene) meetings and/or shares study information with partner(s), as appropriate
Study Management and Oversight
Independently executes effective study operational plans aligned with the strategic program development plan while ensuring compliance to current regulatory guidance and GCPs
Leads development and execution of complex, global operational activities outlined in various study plans, SOPs, study procedures, etc.
Drives site start-up, subject enrollment, clinical monitoring activities, clinical site compliance and data metrics from CROs, central labs, and other external vendors
Leads the development and distribution of critical study documents, including ICFs, operational documents, study reference documents, study newsletters, site materials, and other study related documents; supports the development of clinical study protocols, clinical study reports and other documents as needed
Partners with Global Supply Chain (Technical Operations) team to provide oversight of the applicable study drug(s), including supply projections, distribution, labeling and destruction
Plans, facilitates, and monitors training at investigator meeting(s), kick-off meeting(s), and various CRO (or other vendor) meeting(s)
Performs quality assurance checks (e.g. reviewing protocols for operational effectiveness, monitoring trip reports for potential gaps in site/CRA training, conducting co-monitoring visits at clinical sites, reviewing data listings at interim analysis milestones)
Coordinates IDMCs, when applicable, including: collecting confidentiality agreements, contracts, and conflict of interest forms from IDMC members, reviewing IDMC Charter, planning and scheduling meeting(s)
Supports and collaborates with GCP QA during site selection and site/study audit activities
Leads Clinical Operations preparation of inspection readiness activities for FDA and other applicable regulatory body audits and/or meetings
Minimum Requirements:
Bachelors degree with a life science or healthcare focus or nursing degree required
7+ years experience in a clinical research related position (sponsor experience required) ideal candidate will have rare disease/orphan indications experience
A detailed understanding of overall strategic direction, interrelationships and business needs
Management of CROs with multiple vendors and complex protocols
Proven experience in the oversight of the operational aspects of all stages of clinical studies, preferably in a global environment
Employment Type: Contractor
Job tags
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