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7 days old

Project Manager - Scientific

Kelly Services
St Charles, MO 63303
Kelly Scientific Resources has an immediate opportunity available with our pharmaceutical clients in the greater Saint Louis area. Full time direct placement position available for a Project Manager/ Principle Investigator with 2-5 years of project management or relevant industry experience.



The person in this role will be responsible for supporting scientifically effective and timely definition, set-up and completion of bio-analytical sample analysis studies, including authoring sample analysis plans and reviewing study reports. The Principal Investigator interfaces with external client and their toxicological or clinical partners to scope and define projects; and partners with Method Development and Validation Scientists and Laboratory Scientists to verify the scientific integrity of the data and confirm that procedures comply with internal and/or sponsor Standard Operating Procedures (SOPs) and regulatory requirements. The Principal Investigator serves as the primary Sponsor contact and manages Sponsor relationships as assigned, conducts work assignments in alignment with Sponsor specifications and timelines.



**Essential Duties and Responsibilities:**






+ Serves as a key point of contact for new and existing customers.

+ Manages project flow from project initiation through closeout while monitoring study for contractual adherence.

+ Responsible for interface with Business Development to ensure change orders are timely, if needed.

+ Creates sample analysis plans and manages amendments.

+ Reviews validation plans, validation and sample analysis reports in support of non-regulated and regulated methods.

+ Assures the quality of the data and compliance with applicable SOPs and regulatory requirements.

+ Develops and maintains good working relationships with Sponsors, interfacing with Business Development, and Scientists to communicate and meet Sponsor needs and timelines, while providing technical information and resolving problems.

+ Provides guidance to Scientists and Sponsors on analytical issues, project technical requirements, design and logistics, and regulatory requirements.

+ Organizes resource allocation/scheduling, contributes to company forecasts and revenue recognition based on project specifications and timelines.

+ Designs and improves processes and procedures to increase efficiency, productivity, and quality

+ Travel as needed to visit Sponsor and attend scientific meetings and workshops.

+ Arranges specimen and data handling for all services

+ Transfers reports to customers per agreements

+ Oversees study records, data and sample storage

+ Coordinates transfers of hard copy project records to Quality for archiving

+ Maintains accurate client databases

+ Supports client audits

+ Assists with the writing of company SOPs

+ Applies GxP in all areas of responsibility, as appropriate

+ Works effectively as a member of a team, under minimum direction to achieve client and business deadlines.

+ Attends internal and external training courses.

+ Demonstrates and promotes the company vision

+ Regular attendance and punctuality

+ Conducts all activities in a safe and efficient manner

+ Adjusts work hours as needed to meet client deadlines

+ Adheres to site employee health and safety (EHS) requirements

+ Performs other duties as assigned








+ Bachelor's Degree in a science related field desired or equivalent work experience.

+ 2-5 years of experience as project/program manager







+ Experience in a Contract Research Organization preferred







+ PMP Certification preferred







+ Lean / Six Sigma experience preferred












**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2020-01-13 Expires: 2020-02-13

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Project Manager - Scientific

Kelly Services
St Charles, MO 63303

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