Lead core project team(s) and facilitate team's ability to lead extended/complete project team(s). Depending on size and scope of project(s) ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders. The PM Job duties may be performed in collaboration with a Senior Project Manager and/or Project Director. Provide project focused leadership across departments, offices, external vendors and clients to deliver corporate and department objectives. Proactively identify and resolve conflicts as well as escalate issues as needed. Monitor project scope, schedule and costs to ensure all remain on track per contract. Proactively utilize both quality control and risk management activities to ensure project deliverables are met according to regulatory, client and company requirements. Create required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary. Proactively manage variance to project plans to bring the study back in line with stated project standards. Monthly metrics reports will be reported accurately and on-time to assist in maintenance of project standards. Aid in development and maintenance of key project performance indicators for client specified metrics. Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s). Meet financial performance targets for assigned project(s). Accountable for budget control across assigned project(s) and accurate month-to-month completion of earned value analysis, as assigned, and evaluation and management of billed time to plan to minimize write-off and capitalize on fixed-price gains. Proactively identify out of scope activities and execute necessary change orders prior to out-of-scope work being done. Proactively identify project inefficiencies and address issues proactively to stay within budget. Ensure project procurement needs are managed appropriately and per company SOPs. Collaborate with finance to initiate monthly invoicing as assigned. Ensure that all staff allocated to assigned project(s) adhere to professional standards and SOP and are working within the assigned allocation. Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects. Provide input to proposal teams and participate/present at bid defense meetings. Prepare and actively participate as operational lead in internal Project Review meetings. Depending on size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director. Provide performance feedback of team members to respective line managers. Present at external and/or internal meetings as required. Ensure client satisfaction. Define and manage project human resource needs and establish succession plans for key resources. Responsible for appropriate issue escalation to appropriate stakeholder(s) inclusive of CAIR and CAPA completion as required. Serve as key client contact for assigned project(s). Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business. Prepare and deliver presentations in collaboration with relevant departments for new business as required. May have line management responsibilities for the training, utilisation, development and performance review of assigned staff. Perform other duties as assigned by management.
?University/college degree strongly preferred (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution. Expert knowledge of TA: Oncology (2yrs + as a Project Manager) Experience as a PM working in Phase I and II studies At least 2-4 years of Clinical Project Management experience within a CRO Clinical Project Management experience must be within a Full Service Study and include all functional groups (CRAs, Data Management, Medical, Stats, etc) Working knowledge of project management processes. Working knowledge of time and cost estimate development. Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs. Broad knowledge of drug development process and client needs.