Clinical Project Manager

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. This ensures timelines, quality, and study objectives are met in accordance with corporate objectives, Standard Operating Procedures (SOPs), International Council for Harmonization Good Clinical Practice (ICH GCP), and regulatory requirements. In addition, the ACPM supports the CPM/Senior CPM/Lead CPM by fostering the adoption of innovative practices at .• 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 ensure it is 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:ProtocolsProtocol amendmentsInformed Consent FormClinical Study Reports (CSRs)Regulatory submissionsIMP Handling ManualTMF PlanStudy Management PlanOther study documents/plans as required• Provide support for obtaining 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 and CRO metrics and systems.• Engage in efficient vendor and site coordination.• Participate in study-related meetings, such as:Study Team MeetingsJoint Clinical Study Team (JCST) meetingsInvestigator MeetingsCRA workshopsCRO training sessions• Document team action items and decisions in accordance with the project's communication plan.• Create and maintain the 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 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 MeetingsCSM trainingsSite 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.Additional Responsibilities• Perform other study-related tasks assigned by the study team or CPM/Senior CPM/Lead CPM.Education• Bachelor's degreeCompetenciesThe Associate Clinical Project Manager (ACPM) demonstrates emerging-to-basic knowledge and application of technical and operational project management, interpersonal, and leadership competencies. This typically includes 1-2 years of CRA experience or similar, along with the following:Technical and Operational Project ManagementGeneral project managementClinical project management experience, including understanding of Global Clinical Development and Operations in:• Early Phase Management - Phase 1 or exploratory trials, including first-in-human studies and intensive safety monitoring• Phase 2/3 - Pivotal trials assessing efficacy and safety at scale under regulatory scrutiny• Late Phase and Post-Approval Study Management - Real-world evidence generation, long-term safety follow-up, and market support studies including NIS, PASS, and ISEG studiesTechnical ability using systems and applications and proficiency in Microsoft Office suiteAbility to interpret and use data and key performance indicatorsProcess and operational excellence, including: processes knowledge and process managementLanguages: English (excellent written and oral)Interpersonal SkillsSelf-Management & Personal EffectivenessOrganized and well-structuredTime management and planningSelf-awareness and self-regulationResilienceSense of urgency with calm demeanorCan-do attitude / proactivity / willingness to learn and developRelational Intelligence & CommunicationEmpathyListeningConflict resolutionClear and structured communication with appropriate escalationCultural awarenessGood presentation skillsLeadershipDriving Results & AccountabilityResults and solution-orientedAbility to use circle of influence at all levelsApplication of negotiation skillsStakeholder EngagementCustomer focus and adaptability towards stakeholdersEffective networkingProfessional ExpectationsThe ACPM represents professionally, aligning conduct with values, and possesses the knowledge and experience to perform tasks independently or under supervision, demonstrating desired behaviors within assigned projects and therapeutic areas.Competency level: Learn and Support

Created: 2026-05-16