Senior Clinical Project Manager

Senior Clinical Project Manager

EDETEK is seeking an experienced and highly motivated Senior Clinical Project Manager to lead the planning, execution, and oversight of clinical trials for pharmaceutical, biotechnology, and medical device clients. This role is responsible for cross-functional project leadership from study startup through closeout, with a strong focus on timeline management, sponsor communication, risk management, vendor oversight, and quality delivery.

The ideal candidate will bring solid experience in a CRO environment and hands-on experience coordinating Data Monitoring Committee (DMC) activities, including meeting planning, deliverable readiness, communication management, and follow-up tracking. This individual must be able to manage multiple stakeholders, work effectively in a matrixed environment, and ensure studies are delivered on time, within scope, and in compliance with applicable regulations and company procedures.

Essential Functions and Responsibilities

• Lead and manage clinical study activities from startup through closeout in accordance with protocol, sponsor requirements, project scope, budget, SOPs, GCP, and applicable regulations.
• Serve as the primary operational point of contact for assigned sponsors and maintain strong, professional sponsor relationships.
• Develop, maintain, and manage study timelines, project plans, status reports, action logs, and risk registers.
• Coordinate cross-functional teams, including clinical operations, data management, biostatistics, statistical programming, medical writing, safety, regulatory, and technology teams.
• Facilitate internal project meetings, sponsor meetings, and governance discussions, and ensure timely follow-up on action items.
• Monitor study progress and identify operational risks, quality concerns, and timeline issues, with proactive mitigation and escalation as needed.
• Oversee study vendors and external partners to ensure deliverables are completed with high quality and in accordance with project timelines and expectations.
• Support budget tracking, change order review, scope management, and resource planning in collaboration with leadership and other stakeholders.
• Ensure inspection readiness and support sponsor audits, internal audits, and regulatory inspections, as applicable.
• Promote effective communication and collaboration across global teams and functions.

DMC Coordination Responsibilities

• Lead or support the coordination of Data Monitoring Committee activities for assigned studies.
• Develop and maintain DMC timelines, meeting schedules, communication plans, and tracking tools.
• Coordinate preparation of DMC deliverables, including data cuts, tables, listings, figures, reports, presentations, and meeting materials, in collaboration with biometrics and other relevant functions.
• Monitor readiness of DMC packages and ensure timely collection, review, quality control, and distribution of meeting materials.
• Organize DMC meetings, including logistics, document flow, agenda management, attendance coordination, and follow-up activities.
• Facilitate communication among sponsors, DMC members, independent statisticians, and internal study teams while maintaining required confidentiality and blinding controls.
• Ensure DMC activities are conducted in accordance with the DMC charter, study protocol, sponsor requirements, and applicable procedures.
• Maintain complete and accurate documentation of DMC decisions, recommendations, meeting minutes, and action items.