Project Manager - Peri and Post Approval, Non-Interventional Studies Team

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Project Management
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The Project Manager (PM) is responsible for the overall coordination and management of clinical trials from start up through the final deliverable. Directs the technical and operational aspects of the projects -- thus securing the successful completion of clinical trials.
 
Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, make good business decisions and ensure solutions are implemented. Works to ensure that all project deliverables meet the customer's time/quality/cost expectations.
 
The PM, with support from the Project Management Directors and/or Associate Directors, working in collaboration with other functional area leads, is accountable for ensuring that all project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass through costs and ensuring timely invoicing.

Education and Experience:
  • Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
  • Has proven understanding and experience of working within clinical development (equivalent to four years). This could include specific experience in a particular functional area
  • Can demonstrate evidence of a period of successfully managing and/or leading individuals/team
  • Experience using project management software
  • Solid understanding of how to craft and manage a project budget
  • Must possess a valid passport, as appropriate
Knowledge, Skills and Abilities:
  • Knowledge of the key principles of cross functional project management (Time, Quality, Cost)
  • Solid financial acumen
  • Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen
  • Displays effective communication skills (listening, oral, written) and can communicate in English language (oral,written)
  • Sound interpersonal skills, is flexible and adapts to changing situations
  • Has the ability to persuade, convince, and influence or impress others
  • Is organized, proficient at multi-tasking with good attention to detail
  • Able to lead, motivate and coordinate teams. Coach/mentor team members as appropriate
  • Able to delegate, effectively prioritizes own and workload of project team members
  • Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc
  • Possesses cross cultural awareness and is able to adapt appropriately
  • Has an understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology
  • Has experience with leading, liaising and coordinating cross-functional project teams
  • Has knowledge/understanding of clinical development guidelines and Directives
Working Conditions and Environment:
  • Work is performed in an office/ laboratory and/or a clinical environment.    Exposure to biological fluids with potential exposure to infectious organisms.
  • Exposure to electrical office equipment. 
  • Personal protective equipment required such as protective eyewear, garments and gloves.
Physical Requirements:
  • Ability to work in an upright and /or stationary position for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. 
  • Frequent mobility required. 
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. 
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. 
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. 
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. 
  • Frequently interacts with others to obtain or relate information to diverse groups. 
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. 
  • Regular and consistent attendance.

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