Manager, Clinical Trials

Alternative Resources Company

Manager, Clinical Trials

Manager, Clinical Trials
 
The Clinical Trial Manager (CTM) will lead the planning, implementation and execution of clinical study protocols, operational plans and study timelines for trials in the Rare Disease portfolio. CTM’s manage all aspects of study progress to include protocol development and planning, study close-out and support for the development of clinical study reports. CTM’s ensure adherence to intended timelines, achievement of study goals and trial quality in accordance with FDA, EMA, GCP, and ICH guidelines.
 
Responsibilities
  • Leads the activities of the Clinical Trial Working Group, a cross-company and cross-functional team, as it relates to study-level strategy, timelines, goals, and quality.
  • Acts as ad hoc member of the Development Sub-Team to collaborate in the 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, leveraging solid relationships with key counterparts
  • 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
  • Provides input to the development of study-level budget(s) and demonstrates accountability for the management of assigned clinical study budget(s) by:
    • 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
  • Anticipates, recognizes, and manages issues: Analyzes clinical study and investigative site risks and implements corrective actions, where required
  • Drives quality-by-design efforts to proactively identify and manage risks to trial quality and ensure inspection readiness at all times
  • Drives site start-up, subject enrollment, clinical monitoring activities, clinical site compliance and data metrics from CROs, central labs, and other external vendors
  • Leads development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc.
  • Coordinates 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
  • Tracks clinical study metrics and reports to management on study(ies) run by partners
  • 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
 
Requirements
  • Bachelor’s degree with a life science or healthcare focus or nursing degree required
  • 5+ years’ direct clinical trial management experience (sponsor experience required) – ideal candidate will have oncology/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
  • Exhibits the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can occur at the study team level versus when there is a need for escalation to the program level or to Senior Management
  • Knowledge of ICH GCP and knowledge of Medical Terminology strongly preferred
  • Ability to organize and manage multiple priorities required
  • Excellent oral and written communication skills required
  • Reside in the Greater Boston Area with ability and willingness to travel 25% of the time