Associate Clinical Project Manager (ACPM)

Job Description

Primary Purpose / Regulatory Responsibilities:

• The Associate Clinical Project Manager (ACPM) provides comprehensive operational support to the CPM/Senior CPM/Lead CPM to deliver clinical studies from study protocol through study report and trial master file (TMF) archiving to ensure that timelines, quality and study objectives in accordance with the corporate objectives and Standard Operating Procedures (SOPs), International Council for Harmonization Good Clinical Practice (ICH GCP) and regulatory requirements are met. In addition, the ACPM support the CPM/Senior CPM/Lead CPM by fostering the adoption of innovative practices.
• The ACPM collaborates closely with the CPM/Senior CPM/Lead CPM, who retains overall accountability for the study and determines which activities are delegated to the ACPM.

The following key responsibilities may be delegated by the CPM/Senior CPM/Lead CPM to the ACPM:

Study Documentation Management:

• Maintaining the trial master file (TMF) in an inspection-ready state to be complete, accurate, and legible through section reviews and oversight of cross-functional TMF responsibilities.
• Participate in the review and finalization of clinical study-related documents and plans including, but not limited, to protocols, protocol amendments, Informed consent form, clinical study reports (CSRs), regulatory submissions, IMP Handling Manual, TMF Plan, Study Management Plan and other study documents/plans as required.
• Provide support for obtaining the Clinical Outcome Assessments (COA) and liaising with PCOR Lead, COM and other stakeholders under the supervision of the CPM/Senior CPM/Lead CPM.
• Provide input into contracts, work orders and/or change orders and assist with review and management of invoice tracking/reconciliation.
• Monitor clinical data collection to ensure data quality.

Project Communication:

• Manage stakeholder communications between internal teams and designated vendors.
• Track study status and deliver updates and reports to stakeholders and senior management using client and CRO metrics and systems.
• Engage in efficient vendor and site coordination.
• Participate in study-related meetings, such as Study Team Meetings, Joint Clinical Study Team (JCST) meetings, Investigator Meetings, CRA workshops, and CRO training sessions.
• Document team action items and decisions in accordance with the project’s communication plan.
• Create and maintain the client Study Team list, manage study SOP listings, and provide periodic updates.
• Set up, maintain, and close study MS Teams channels and facilitate communication across these platforms, in collaboration with CROs as applicable

Quality Management & Process Improvement:

• Support audit and inspection activities, ensuring readiness and timely resolution of findings in compliance with regulations (e.g., ICH GCP) and quality standards.
• Assist with suspected serious breach assessments when applicable.
• Contribute to process improvement initiatives, seeking efficiencies between client and CRO systems (e.g., CTMS, TMF, Source Quality, SharePoint, Microsoft Teams), and share best practices with line managers, peers, and partner CROs.

Training Support:

• Develop and oversee study-specific training to ensure Study Team Members (STMs) adhere to protocol and study procedures.
• Maintain the training matrix, including compliance tracking and development of training packages for Investigator Meetings, CSM trainings, and site initiation visits.
• If delegated, oversee operational aspects of Investigator Meetings, collaborating with CROs, meeting planners, and vendors, and manage associated documentation and follow-up actions.

System Support:

• Set up studies in the Clinical Trial Management System (CTMS).
• Conduct ongoing and final quality control checks in CTMS, liaising with CROs, CPMs, and CSOL (for iHome studies) to provide feedback and resolve issues.
• Provide helpdesk support for clinical systems used by sites and sponsors.
• Perform other study-related tasks assigned by the study team or CPM/Senior CPM/Lead CPM.

Education:

• Bachelors