Project Manager- MTCC

Job Description

The Project Manager will oversee the planning, execution, and management of multisite clinical trials coordinated through Multisite Trial Coordinating Center. This role ensures that all participating sites adhere to protocol, regulatory requirements, and timelines, while maintaining high standards of data quality and participant safety. The Project Manager will serve as a central liaison between investigators, site staff, sponsors, regulatory bodies, and internal teams.

Key Responsibilities:

• Project Oversight amp; Coordination
  • Lead the development and implementation of project plans, timelines, and deliverables for multisite clinical trials.
  • Coordinate communication across all participating sites and stakeholders.
  • Monitor trial progress and proactively address risks, delays, or deviations.
• Regulatory amp; Compliance
  • Ensure compliance with ICH-GCP, FDA regulations, and institutional policies.
  • Oversee IRB submissions, renewals, and reporting across all sites.
  • Maintain essential regulatory documents and trial master files.
• Site Management
  • Support site selection, initiation, training, and ongoing management.
  • Track site performance metrics and provide guidance to improve efficiency and compliance.
  • Facilitate regular site meetings and communications.
• Data amp; Quality Management
  • Collaborate with data management teams to ensure timely and accurate data collection.
  • Participate in monitoring visits and audits as needed.
  • Implement quality assurance processes to ensure protocol fidelity.
• Budget amp; Resource Management
  • Assist in budget development and track project expenditures.
  • Coordinate with finance and grants management teams to ensure fiscal compliance.

Requirements:

• Bachelors degree in health sciences, public health, or related field (Masters preferred).
• Minimum 5 years of experience in clinical research, with at least 2-3 years in project management of multisite trials.
• Strong knowledge of clinical trial regulations and guidelines (e.g., GCP, FDA, NIH).
• Experience with IRB processes, regulatory submissions, and site coordination.
• Excellent organizational, communication, and leadership skills.
• Proficiency in project management tools and clinical trial management systems (CTMS).

Preferred Qualifications:

• PMP or ACRP/SoCRA certification.
• Experience working in an academic or NIH-funded coordinating center.
• Familiarity with REDCap, OnCore, or similar platforms.