With supervision from Management, the Project manager (PM) role is to implement agreed upon strategies for the management of national or international internet-based outcome studies with pre-specified timelines and budgets. The PM leads the project team and is responsible for the successful conduct and completion of the project to the contracted budge and timelines and for ensuring the quality of the project according to ICH/GCP (if applicable), Outcome and/or Sponsor SOPs, guidelines and requirements. In addition, the PM will serve as the point of contact for internal/external customers and act as the liaison to the Sponsor for study-related issues. Supports Business Development and acts as a mentor or supervisor for less experienced clinical operations staff.
- Leads projects that may include monitoring, EDC development (production and maintenance,) data management, programming, safety, statistics, report/protocol writing, medical affairs and agency presentations and ensure these requirements are properly documented.
- Manages and supports project goals within Clinical Operations including startup activities focused around site identification, contract (CTA) and budget, patient recruitment, enrollment and monitoring plans, marketing and public relations campaigns per the project plan and associated timelines.
- Within a matrix environment, coordinate and manage all deliverables, milestones and deadlines related to assigned studies/projects, including site enrollment, regulatory and IRB/EC approvals, and patient enrollment and follow-up.
- Provide the Clinical Site Management team with the information and tools needed to ensure their ability to support the program both initially and throughout the project duration.
- Work closely with the cross functional teams (such as Development, Quality Control, Data Management, Statistics) to lead resources during the design, development, testing and implementation phase of EDC, including answering questions and clarifying requirements for the clinical design
- Act as customer advocate throughout the project lifecycle.
- Serve as the liaison between the clients and internal team to ensure project-specific information and ongoing updates are proactively communicated. Assure that meeting minutes and communication of decisions and action items are documented appropriately in minutes.
- Firm understanding the contractual obligations to each client and ensure those responsibilities are met (with the goal to exceed those expectations). Supports the development and review of the proposal and budget to align with the SOW.
- Understand client’s expectations for the study and define project requirements, deliverables, schedules and budgets.
- Identify out-of-scope tasks and client requests per change management and support and/or the development of Change Orders that align with Sponsor expectations.
- Provides monthly status reports to sponsor and/or internal purposes, financial reports requirements utilizing corporate reporting tools (PSR Meetings), Invoice Generation and revenue review (ETC and Project Margin), Timesheet review, and pass-through cost review as applicable.
- Guide client through EDC configuration and customization decisions including driving the software features versus cost/schedule trade-off decisions with the client. Ability to understand and offer customization options that align with the technical group's capabilities. This includes managing internal resourcing ageist client timelines and user requirements.
- Identify and implement strategic opportunities to enhance and improve the project (e.g., site retention activities). This includes risk management, contingency planning, enrollment strategies that will support the project objectives.
- Develop, Review and/or maintain clear study related documents, including supporting system specifications that require technical writing. Ensures all critical study documentation (i.e., DMP, Monitoring Plan, SAP, and Training) is collected and filed in TMF/eTMF so that we are audit ready.
- Manage the preparation, maintenance and traceability of central and site files (TMF/eTMF) for projects with the functional leads.
- Adhere to internal change management processes per our internal SOPs, WI and project specific process. Including project specific quality initials to assure that projects are audit ready.
- Coordination and management of external providers/vendors as applicable.
- Deliver presentations at internal staff meetings and to existing clients.
- Identify and support business development opportunities.
- Participate in the development, review and drafting of proposals and then participate in the bid defense meetings as required.
- Mentor and/or manage project management staff and other team members as applicable.
- This job description may include additional individual duties and responsibilities not listed in detail but still expected to be reasonably performed.
- Bachelor’s degree with 3 or more years of Project Management experience in the health care, medical research, CRO or healthcare technology setting.
- Knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and understanding of the clinical development process (Phase I-IV, post marketing, abstraction protocols and/or REMS).
- Excellent time management and organizational skills, able to produce high quality work independently or as part of a team, be able to multi-task and work in a high volume, deadline controlled environment.
- The ability to learn quickly, multi-task and prioritize are essential.
- Must be proficient in MS Office applications.
- Management or mentoring experience a plus.
- Must be hard-working and have the ability to work very independently.
- Problem solving skills; very strong written, verbal communication skills.
- Leadership skills in an international environment and customer service oriented.
- Demonstrated success in Project Management.
- Ability to travel and attend international meeting.
Quintiles Transnational - 9 months ago
Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...