Senior, Clinical Trial Manager, CTM - FSP (North America, EAST COAST)

Position Overview

• Location Type: Remote
• Job Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office
• Role: Senior CTM, Clinical Trial Manager, FSP Dedicated
• Location: US, Remote (Candidate MUST be located on the East Coast, CST considered, but East Coast highly preferred)

This role involves coordinating clinical monitoring activities, overseeing CRO clinical/site management, and co-monitoring international Phase 3 clinical studies. The objective is to ensure adherence to regulatory requirements, GCP guidelines, and SOPs, maintaining high standards of quality, timely delivery, and budget adherence to achieve clinical development objectives and clinical excellence. The Senior CTM will coordinate the achievement of assigned clinical study deliverables within a matrix organization under the CPM's leadership, acting as a client representative at sites and building relationships with investigators.

Main Responsibilities/Job Expectations

• Clinical Activities Coordination & Oversight:
  • Ensure efficient and thorough study start-up by overseeing the CRO's Clinical team and collaborating with relevant team members (DM, Reg, CMC, etc.).
  • Review feasibility reports as per the oversight plan.
  • Support the CPM in site selection.
  • Verify timely collection of essential study documents (regulatory, ethics committee documents for submission).
  • Control that all setup activities are performed prior to each site initiation, as per the oversight plan.
  • Support and ensure completion of specific Client/CRO EDC system tasks under clinical responsibility according to defined timelines.
  • Support the Clinical CRO in training CRAs on study-specific operational activities.
  • Participate in the organization and preparation of monitor and investigator meetings in collaboration with study team members (Corporate, affiliates, CROs).
  • Assist the CPM/study team in evaluating detailed timelines and establishing clinical study milestones, ensuring quality and timely delivery.
  • Prepare and/or assist in the production of documents necessary for overseeing clinical activity implementation, monitoring, and reporting.
  • Customize site Key Risk/Performance Indicator (KRI/KPI) templates and monitor these at agreed frequencies.
  • Validate final clinical study documents (e.g., study manual, monitoring plan) prepared by the Clinical CRO.
  • Review site visit reports as per the Oversight Monitoring Plan, ensuring timely and appropriate follow-up of issues raised by monitors.
  • Provide support and guidance to Internal CRAs (Corporate & Affiliates), including supervision in specific cases.
  • Coordinate and manage CRO relationships, assisting CRO CRAs/CTLs as needed.
  • Collaborate with the CPM in the RFP process and participate in BID defense meetings.
  • Set up regular meetings with MSLs (Medical Science Liaison) at LMA (Local Medical Affairs) for support in clinical operations.
  • Contribute to the efficient operation of the TA Group and transversal projects across TAs and other departments (e.g., systems implementation, change management, continuous improvement).
  • Ensure the monitoring oversight of entrusted activities.
  • Co-monitor clinical studies according to the oversight plan, ensuring adequate contact.

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