Associate Clinical Project Manager (ACPM)

Please note: in line with *** policy, this role is VDI only. *** will not be providing a laptop or equipment.Primary Purpose / Regulatory Responsibilities:" The Associate Clinical Project Manager (ACPM) provides comprehensive operational supportto the CPM/Senior CPM/Lead CPM to deliver clinical studies from study protocol throughstudy report and trial master file (TMF) archiving to ensure that timelines, quality and studyobjectives in accordance with the corporate objectives and *** Standard OperatingProcedures (SOPs), International Council for Harmonization Good Clinical Practice (ICH GCP)and regulatory requirements are met. In addition, the ACPM support the CPM/SeniorCPM/Lead CPM by fostering the adoption of innovative practices at ***." The ACPM collaborates closely with the CPM/Senior CPM/Lead CPM, who retains overallaccountability 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 theACPM: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 TMFresponsibilities." Participate in the review and finalization of clinical study-related documents and plansincluding, 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 withPCOR Lead, COM and other stakeholders under the supervision of the CPM/SeniorCPM/Lead CPM." Provide input into contracts, work orders and/or change orders and assist with reviewand 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 seniormanagement using *** and CRO metrics and systems." Engage in efficient vendor and site coordination." Participate in study-related meetings, such as Study Team Meetings, Joint Clinical StudyTeam (JCST) meetings, Investigator Meetings, CRA workshops, and CRO trainingsessions." Document team action items and decisions in accordance with the project scommunication plan." Create and maintain the *** Study Team list, manage study SOP listings, and provideperiodic updates." Set up, maintain, and close study MS Teams channels and facilitate communicationacross these platforms, in collaboration with CROs as applicableQuality Management & Process Improvement:" Support audit and inspection activities, ensuring readiness and timely resolution offindings 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 *** andCRO systems (e.g., CTMS, TMF, Source Quality, SharePoint, Microsoft Teams), and sharebest 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 trainingpackages for Investigator Meetings, CSM trainings, and site initiation visits." If delegated, oversee operational aspects of Investigator Meetings, collaborating withCROs, meeting planners, and vendors, and manage associated documentation andfollow-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, andCSOL (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 - BachelorsCompetencysAn Associate Clinical Project Manager (ACPM) demonstrates an emerging-to-basic knowledgeand application of technical and operational project management, interpersonal, andleadership competencies, which will include 1-2 years of CRA experience or similar and alsothe following:Technical and operational project management:- General project management- Clinical project management:o Operational clinical project management experience (phase 1 to phase 4studies), including an understanding of the complexities of Global ClinicalDevelopment and Operations in:o Early Phase Management Experience with Phase 1 or exploratory trials,often involving first-in-human studies and intensive safety monitoring.o Phase 2/3 Experience in pivotal trials that assess efficacy and safety atscale, often under regulatory scrutiny.o Late Phase and Post-Approval Study Management Involvement in realworld evidence generation, long-term safety follow-up, and marketsupport studies. Includes NIS, PASS, and ISEG studies.- Technical ability (using *** systems and applications and proficiency in the Microsoftoffice suite)- Ability to interpret and use data and key performance indicators- Process and operational excellence:o *** processes knowledge and process managemento Languages: English: excellent written and oral.Interpersonal:- Self-Management & Personal Effectiveness:o Organized and well-structuredo Time management and planningo Self-awareness and self-regulationo Resilienceo Sense of urgency with calm demeanoro Can-do attitude / proactivity / willing to learn and to develop- Relational Intelligence & Communication:o Empathyo Listeningo Conflict resolutiono Clear and structured communication with appropriate escalationo Cultural awarenesso Good presentation skillsLeadership:- Driving Results & Accountability:o Results and solution orientedo Ability to use circle of influence at all levelso Application of negotiation skills- SP Stakeholder Engagement:o Customer focus and adaptability towards stakeholderso Effective networkingThe ACPM represents *** professionally, aligning conduct with *** values, and possessesthe knowledge and experience to perform tasks independently or under supervision,demonstrating desired behaviors within assigned projects and therapeutic areas.