
Clinical Project Manager
ob Summary
The Clinical Project Manager (CPM) will oversee the planning, execution, and delivery of clinical trials (Phases I-IV) in compliance with regulatory standards (ICH-Google Cloud Platform, FDA, EMA, etc.). The CPM will lead cross-functional teams, manage timelines/budgets, and ensure adherence to protocols while maintaining quality and patient safety.
Key Responsibilities
Project Leadership:
Serve as the primary point of contact for sponsors, CROs, vendors, and investigative sites.
Lead cross-functional teams (clinical, regulatory, data management, biostatistics) to ensure trial milestones are met.
Develop and manage project plans, including timelines, budgets, and risk mitigation strategies.
Clinical Trial Management:
Oversee study start-up, site initiation, patient recruitment, monitoring, and close-out activities.
Ensure compliance with protocols, SOPs, and regulatory requirements (FDA, EMA, ICH-Google Cloud Platform).
Review and approve essential trial documents (e.g., CRFs, informed consent forms, monitoring plans).
Vendor & Stakeholder Management:
Manage relationships with CROs, central labs, IRBs/ECs, and other third-party vendors.
Coordinate with investigators and site staff to resolve operational issues.
ob Summary
The Clinical Project Manager (CPM) will oversee the planning, execution, and delivery of clinical trials (Phases I-IV) in compliance with regulatory standards (ICH-Google Cloud Platform, FDA, EMA, etc.). The CPM will lead cross-functional teams, manage timelines/budgets, and ensure adherence to protocols while maintaining quality and patient safety.
Key Responsibilities
Project Leadership:
Serve as the primary point of contact for sponsors, CROs, vendors, and investigative sites.
Lead cross-functional teams (clinical, regulatory, data management, biostatistics) to ensure trial milestones are met.
Develop and manage project plans, including timelines, budgets, and risk mitigation strategies.
Clinical Trial Management:
Oversee study start-up, site initiation, patient recruitment, monitoring, and close-out activities.
Ensure compliance with protocols, SOPs, and regulatory requirements (FDA, EMA, ICH-Google Cloud Platform).
Review and approve essential trial documents (e.g., CRFs, informed consent forms, monitoring plans).
Vendor & Stakeholder Management:
Manage relationships with CROs, central labs, IRBs/ECs, and other third-party vendors.
Coordinate with investigators and site staff to resolve operational issues.