Senior Project Manager

Position Summary:

Oversee all associated activities related to a Phase I/BE study program from inception (i.e. Study award) to completion (i.e. issuance of final report). Maintain awareness of overall study requirements in accordance with finalized protocol and ensure this is adhered to.

Duties and Responsibilities:

• Maintain a tracking process for the studies managed; including initiation, tracking, timelines reporting, budgeting and report writing 
• Within scope of position, provide sound scientific advice to clients either directly or via other BPSI staff; co-ordinate teleconferences with appropriate personnel, address client questions, concerns or comments
• Negotiate client's milestones and assist staff as required
• Use appropriate communication tools to update clients on the status of their project(s); should there be any deviation, immediately handle them appropriately and if required notify Director, Project Management and/or Operations Management
• Actively participate in the weekly tracking meeting making to ensure timelines are current with the most up-to date information from operations and provide any new information available from the client
• Create and develop proposals for review and receive appropriate approvals as required
• Follow up with existing accounts on new business opportunities and manage activities around outstanding proposals and contracts
• Assist in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion (includes quotation and contract templates, weekly tracking reports, financial reports etc.)
• Ensure appropriate documents have been reviewed and circulated within BPSI prior to providing to clients 
• If required, assist in promotion of BPSI at industry meetings and trade shows
• Maintain a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA, ICH, TGA, ANVISA) and understanding of basic pharmacokinetics and statistics
• Assist finance department in developing transfer of pertinent financial information
• Coordinate client visits and follow up on requested documents from clients including, but not limited to, regulatory documents, study documents, validation report and brochures
• Perform other tasks and projects as assigned

Qualifications:

• Bachelor of Science (B.Sc.) degree or equivalent
• Relevant background in the healthcare, pharmaceutical industry
• Minimum of 3 years' experience in a project management role in either Phase I/BE or Phase I - IV setting
• Excellent understanding of how studies are run and how they are managed
• Demonstrated experience dealing with a wide variety of project stakeholders at all levels in and across various organizational departments
• Excellent interpersonal, communication and presentation skills 
• Strong organization, prioritization and problem solving skills
• Ability to manage and handle several projects simultaneously
• Highly proficient in MS Office Suite (Word, Excel, PowerPoint, MS Project)