Sr Project Manager
The Senior Project Manager (SPM) is responsible for the overall coordination and management of clinical trials from start up through close out activities according to contractual time, quality/ cost parameters. The SPM leads cross-functional teams and works with major functional area leads to identify/mitigate/escalate project issues and ensures solutions are implemented. Moreover, the SPM is accountable for ensuring that all project deliverables meet the client/contract expectations, adhering tocompany standards/processes while ensuring overall client satisfaction. Specific tasks would include:
- Primary interface with Client representatives as well as staff members in functional departments to ensure the timely initiation and completion of clinical trials.
- Assigned to manage the full range of projects; from the small limited in scope projects (e.g., data management, etc) to the full service, large scale, complex programs.
- Attend and present at client bid defense meetings. Prepares proposals, budgets and contracts.
- Represents Project Management on company-wide project teams.
- Interacts with clients and company vendors to ensure that all contractual obligations are met.
- Identifies potential bottlenecks and/or delays; develops and executes contingency plans in order to keep the project on schedule.
- Ensures adequate resource requirements.
- Coordinates initial client meeting identifying project objectives.
- Develops Project Management Plan to include timeline and milestones. Coordinates Project Team Meetings, including development of meeting agendas and minutes.
- Coordinates study specific training and other requirements for internal and external staff, as appropriate.
- Conducts daily, on-going communication via telephone and email, responding to inquiries and client requests. Interacts with clients and vendors to ensure that all contractual obligations are met.
- Interacts with company departments relating to project finances and information technology through the use and development of specific tracking and invoicing procedures.
- Manages budget throughout the duration of the project and develops out of scope documentation and costs.
- Contributes to the revision of Standard Operating Procedures, guidelines, and departmental policies.
- Manages the project trial master files. Produces periodic reports.
- May identify and assist in departmental training requirements including internal and external operations and project manager mentor programs.
- Ensures knowledge of clinical research, clinical therapeutics and regulatory issues, is current through review of journal articles and attendance of relevant professional association meetings.
- Bachelor / Master degree, in a related field of study and a minimum of 5 years applicable CRO industry experience or equivalent combination of education and experience.
- At least 3 years of experience as a PM is required.
- Direct experience in conducting large scale full-service clinical trials is a must.
- A good understanding of project management techniques.
- Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations
- Good proficiency in Microsoft Word, Excel, and PowerPoint, Outlook. Effective verbal and writing skills; English + local language, if relevant.