Project Director

at  Bio Pharma Services

POSITION SUMMARY:

Reporting to the Director of Project Management, the Project Director will provide integrated direction, management and leadership in the administrative and project planning, budgeting, and process improvement efforts of Phase I studies and Key Accounts impacting core functions and components across the organization.

QUALIFICATIONS:

• Bachelor of Science (B.Sc.) degree or equivalent; at least 5 years of experience directly related to the duties and responsibilities specified.
• Relevant background in the healthcare and/or pharmaceutical industry.
• Minimum of 5 years’ experience in a senior project management role in either Phase I or Phase II - 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 organizational skills with the ability to adapt and adjust to changing priorities, apply and problem-solving skills.
• Demonstrated ability to independently manage multiple projects simultaneously.
• Highly proficient with Microsoft Office Suite (Word, Excel, PowerPoint, MS Project).

• Directs and integrates the activities of multiple, major project operations; manages a diverse team of professional and support staff, both directly and through managers and/or supervisors.
• Participates and oversees the development, implementation, and maintenance of individual project objectives.
• Leads the development of processes and procedures for Phase I projects and its execution as directed by Director of Project Management.
• Working under the direction of the Director of Project Management champions change and effectively manages the implementation of new strategic ideas and key process improvement initiatives within department or across operational segments of Bio Pharma Services Inc.; achieves excellence in all areas of business.
• As needed or assigned, acts as a support/backup to Director of Project Management.
• Supports and solicits input from team member at all levels within the organization.
• Continuously defines ways to increase client satisfaction and deepen client relationship; ensures service delivers superior satisfaction to clients and provides senior level resolutions.
• Lends expertise to internal teams and enforces current policies and procedures.
• Grows long-term relationship with clients and capitalizes on potential opportunities.
• Provides leadership and guidance in all aspects of the project life cycle.
• Maintains a tracking process for the studies managed, including initiation, tracking, timelines reporting, budgeting and report writing.
• Within scope of position, provides sound scientific advice to clients either directly or via other BPSI staff; co-ordinates teleconferences with appropriate personnel, addresses client questions, concerns and/or comments.
• Negotiates client’s milestones and assist internal stakeholders as required.
• Uses 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 participates in the weekly tracking meeting to ensure project timelines are current with the most up-to date information from operations and to update operational team of any new information available from the client.
• Leads feasibility assessment of complex Phase I projects with key department stakeholders; provides support in the review and development of proposals on as-needed basis.
• Proactively recognizes any change in scope; collaboratively works with Contracts & Proposals team and Business Development to develop and ensure timely completion and issuance of change orders.
• Follows with existing accounts on new business opportunities and manage activities around outstanding proposals and contracts.
• Assists 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.
• Ensures appropriate documents have been reviewed and circulated within BPSI prior to providing to clients.
• If required, assists in promotion of BPSI at industry meetings and conferences.
• Maintains a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA, ICH, TGA, NMPA, ANVISA) and understanding of basic pharmacokinetics and statistics.
• Coordinates client visits and follow up on requested documents from clients including, but not limited to, regulatory documents, study documents, validation report and brochures.
• Performs miscellaneous job-related duties and other task as assigned.