Clinical Trial Manager

The Clinical Trial Manager (CTM) leads the planning, implementation and execution of clinical study protocols, operational plans and study timelines, in alignment with study/program goals and company 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 Contract 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 is responsible for 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.

• 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. Builds solid relationships 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
• 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
• Participates in partnership meetings and/or shares study information with partner(s), as appropriate Risk/Issue Analysis and Reporting
• Anticipates, recognizes, and manages issues: 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
• 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 our partners (e.g. Celgene), as applicable
• Plans, facilitates, and monitors training at investigator meeting(s), kick‑off meeting(s), and various CRO (or other vendor) meeting(s)
• Performs quality…