Job Description

Position Summary:

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To 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 in all projects managed under your responsibility.

Duties and Responsibilities:

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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 Actively participate in the weekly tracking meeting making sure you are current with the most current information from operations and provide any new client information Create and develop quotations for review by DPM and receive appropriate signatures as required Follow up with existing accounts on new business opportunities and manage activities around outstanding quotations, Confidentiality Agreements, Contracts etc. Whenever appropriate, maintain awareness and provide input on study designs and protocols 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:

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Bachelor of Science (B.Sc.) degree or equivalent Relevant background in the healthcare, pharmaceutical industry Minimum of 2 years experience in a project management role in either Phase I/BE or Phase I - IV setting Familiarity with the management of all phase I/BE 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)