The goal of a Clinical Project Manager (CPM) in Europe is to drive developmental and clinical research projects utilizing best practices in order to ensure budgets, timelines and performance requirements are met. The CPM will manage multiple projects ranging in size and complexity with minimal interaction from the Sr. Director of Clinical Operations. The role requires active involvement to meet schedules or resolve problems or conflicts, and entails frequent interaction with subordinates, outside customers, functional peer groups at various management levels and senior management. May oversee less experienced Clinical Project Managers, CTAs and other office staff.
Manages cross functional project teams derived from the groups within clinical development to deliver a high quality clinical trial(s).
Drives all aspects of the project management process from initiation, planning, execution, control and closure.
Manages all aspects of a clinical trial proactively.
Develops enrollment projection, timeline, and hours required for the study as part of the overall study budget.
Responsible for maintaining the ongoing timelines for each study, and uses these timelines to track and manage a study’s progress.
Responsible for ongoing budget tracking and progress reviews for each study.
Oversee and/or review of the development and writing of ICF, source documents and eCRFs, and tracks them to completion.
Review of the clinical protocol for operational considerations.
Writes or oversees the development and writing of all study plans.
Reviews study-related materials created by the Monitoring and Data Management Groups (e.g. study training manuals, monitoring plan, data management plan, Statistical Analysis Plan).
Ensures review of Clinical Trial Master File for completeness.
Reviews actual trial conduct and quality at all levels (i.e. monitoring, data management).
Responsible for periodic (weekly, or as needed) clinical trial team meetings both internal and with the Sponsor.
Reviews study metrics for performance and quality with the team and management.
Informs all functional leads of deliverables and timeline, project developments and insures completion according to timelines. Ensures all respective study functional leads provide deliverables on time (e.g. query generation and resolution, data base lock, study report).
Manage and coordinate all vendors involved in the clinical trials, e.g. central labs, reading centers
Prepares high-quality reports (financial, project, etc.) for management on program status and issues.
Position has overall responsibility to deliver the projects on time and on budget. The CPM drives study conduct to timely completion in compliance with all regulations and SOPs.
Negotiates and manages competing priorities across multiple functional areas.
Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory), coordinating these different groups in a matrix environment to drive and complete clinical programs.
Develops strong relationships with current and prospective clients to generate new and/or add-on business opportunities. Supports business development by participation in bid defense or capabilities presentations.
Serves as a team leader and actively line manages and mentors other project management and clinical monitoring staff. Facilitates team building and communication.
May represent Ora at professional meetings or seminars.
REQUIRED SKILLS AND ATTRIBUTES:
Highly effective organizational and communication skills.
Demonstrated expertise of EMA, FDA and GCP regulatory requirements required.
Demonstrated leadership skills and the ability to solve problems proactively.
Travel of up to 30% is required (mainly domestic, overnight)
Proficient in use of Microsoft Office suite software, including Outlook, Word, Excel, PowerPoint and Publisher
Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term company objectives.
BS or MS in a Life Science, 3+ years of industry clinical project management experience, 5+ years of industry clinical experience.