Clinical Project Manager

WHAT DOES A CLINICAL PROJECT MANAGER DO? Updated: Nov 22, 2024 - The Clinical Project Manager oversees the planning and operational activities with clinical diagnostic customers, ensuring comprehensive care and robust support. This role involves serving as the primary liaison between internal teams and external clinical customers, coordinating closely with the Laboratory Operations team and Genetic Counselors to maintain updated timelines and quality standards for ongoing clinical cases. The manager also ensures projects adhere to SOPs, GLP, CLIA, and other regulatory requirements, while efficiently handling logistics, quality control, and documentation to keep projects on schedule, within budget, and aligned with defined quality standards. Project Management: Prepare and implement a project plan to ensure quality, on-budget, on-time completion of projects in adherence with client specifications. Facility Management: Ensuring that site facilities and staff are adequate to meet the demands of clinical trials conducted at the site. Protocol Review: Reviewing and providing input to clinical trial protocols. Staff Management: Preparing and managing site staff in the conduct of all protocol-related activities. Policy Implementation: Reviewing, approving, and implementing strategies, policies, and standard operating procedures. Meeting Participation: Attending site initiation meetings, investigator meetings, and other meetings related to clinical research activities. Budget Compliance: Developing, supporting, and complying with the annual budget, including billability levels, revenue, and expense targets. Proposal Development: Development of proposals in response to RFPs from pharmaceutical and biotech companies. Sponsor Liaison: Serve as the primary contact with the sponsor regarding overall study conduct, timelines, and budget. Resource Allocation: Allocation of resources to the study including outsourcing and the identification of vendors. Program Support: Independently supports the HiFiBiO portfolio of Immuno-Oncology, Infectious Disease, and Auto-Immune Disease antibody programs primarily in post‑IND stages (preclinical, clinical management). Strategic Planning: Works in partnership with project leaders to develop, gain approval, and execute the project plans and strategy. Vision Translation: Translates the program's strategic vision and objectives into execution. Leadership: Leads teams through the planning and execution of key milestones. Project Integration: Integrates the project plans appropriate to the phase and complexity of the project along with strategic and tactical input from diverse disciplines. Meeting Facilitation: Co‑chairs timely, efficient, and action‑oriented Project Team meetings and coordinates complex team operations and communications. Timeline Management: Ensures project timelines, study reports and risk management plans are fully developed and updated. Status Reporting: Summarizes the project status/issues for senior management. Study Management: Manages regional/global multi‑center oncology, ID, or autoimmune clinical studies. Clinical Oversight: Oversees clinical studies, interacting with CROs, study vendors, and Investigators to ensure goals and objectives are accomplished within projected timeframes and budget requirements. 3. Clinical Project Manager Responsibilities Stakeholder Communication: Provide continuous communications and project updates to stakeholders and will be in a customer‑facing position. Service Collaboration: Collaborates with service providers, serving as a primary point of contact for internal and external teams regarding progress on project/program goals. Clinical Communication: Communicate directly with Physicians and other Clinicians. Clinical Reporting: Responsible for the delivery of clinical reports to the endpoints specified on customer request forms. Issue Resolution: Proactively identifies issues and drives the team to find solutions. Develops contingency and troubleshooting plans. Metric Tracking: Tracks pertinent project metrics such as turnaround time. Process Creation: Creates processes and documentation where required, such as authoring SOPs and other instructional documents. Documentation Development: Develop project documentation per project scope of work, including case report forms, regulatory binder development, drug accountability logs, screening and enrollment logs. Budget Management: Tracking and managing the budget allocated to the project and reporting on the overall trial budget. Clinical Site Management: Site selection, initiation, and start‑up activities in collaboration with the Clinical team, as applicable. Document Storage Oversight: Oversee the storage of documents, in temporary or long‑term storage following standard procedures. 4. Clinical Project Manager Functions Patient Safety and Process Efficiency: Ensures the safety of patients first and foremost, and efficient streamlined processes are in place to deliver study to plan, and completeness/integrity of data. Document Development and Delivery: Ensures development, review, finalization, and delivery of high‑quality key clinical study documents to meet study timelines. Regulatory Report Editing: Edits and assists in formatting reports aimed at regulatory purposes (e.g., IND filing, and other needs). Study Communication Accountability: Is accountable for study‑related communications and resolution of operational issues with all related project members and departments. Operational Issue Escalation: Involves escalation of complex operational issues or improvement of departmental processes. Project Data Maintenance: Maintains accurate project data and timelines in MS Project or other PM database, e.g., Waterfall. Regulatory Adherence: Adheres to Good Clinical Practice and all applicable local and international regulations. Contract and Communication Management: Ensures contracts are adhered to, control procedures are followed, and communications within and from the team are clear and effective. Cross‑functional Collaboration: Collaborates/aligns with Scientific, Clinical, Finance, and external leaders to achieve the goals of the project and ensure appropriate planning and management of resources and budgets. Meeting Facilitation and Documentation: Prepares for, facilitates, and documents outcomes of team meetings, ensuring meetings have a clear purpose, objectives, action items, and obstacles are surfaced and resolved. PM Coaching and Training: Provides Project Management coaching and training to other company staff to instill a project management mindset across the organization. Personal Development and Training Participation: Actively participates and completes ongoing training and personal development activities to increase leadership and/or project management competency. 5. Clinical Project Manager Tasks Operations and Planning Management: Manage all planning and operations activities with clinical diagnostic customers to provide complete care and customer support. Stakeholder Communication: Work closely with the Laboratory Operations team and Genetic Counselors to keep customers and internal stakeholders up to date regarding the timeline and quality of ongoing clinical cases and then drive the completion of these cases. Customer Service Provision: Provide customer service and support to Clinicians engaged with services. Customer Liaison: Serves as the main point of contact for internal teams and external clinical customers. Logistics Coordination: Coordinate logistics for biological sample procurement. Quality Control Support: Supports operations by using internal systems to perform quality control on data deliverables. Project Management: Ensure that projects remain on schedule and within budget, are appropriately resourced, and meet quality standards according to SOPs, GLP, CLIA and/or other regulatory requirements/guidelines. Documentation Management: Prepare, edit, and update project timelines and documentation (i.e., required forecasting, budget, deliverables, reports, agendas, minutes, tracking sheets, etc.) to ensure successful execution and completion of outlined deliverables. #J-18808-Ljbffr Lamwork