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Description

Position Overview

The Senior Project Manager 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 to company standards/processes while ensuring overall client satisfaction. *Please note: this position may be hired at the Project Manager or Senior Project Manager level dependent upon individual experience.

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.

Qualifications

• Bachelor / Master degree, in a related field of study and a minimum of 5 years applicable 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 and Internet Explorer
• Effective verbal and writing skills; English local language, if relevant.

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