Location: Gaithersburg, MD
Name: Gail Robilliard
Kelly Services has an opening for a Study Manager in Gaithersburg, MD. This is a one-year assignment. The Study Manager plans and manages all aspects of Investigational Product (IP) supply for assigned clinical studies. The Study Manager works collaboratively within Logistics and Clinical Supply (LCS) to provide seamless delivery of Vendor, Distribution and Systems management activities; liaises with interfaces and stakeholders internally and externally as required to ensure highly effective clinical supply planning and execution, including on-going responsiveness to any changes that may impact supply strategy; a contributes to the operational effectiveness of Logistics and Clinical Supply.
Major Duties and Responsibilities
- Plan and manage IP supply for assigned clinical studies. Using defined tools and procedures create documentation required to support IP supply activities; Provide IP input into all relevant study related documents and activities; Maintain oversight of the activities related to processing of product complaints, non-conformances, product recalls or inquiries pertaining to IP received from clinical sites, depots or couriers.
- Create, or assist in the creation of departmental SOPs, systems and processes to support improvement and future growth of Study Management best practice
- Collaborate effectively within LCS to provide close coordination of Vendor, Distribution and Systems management activities for assigned projects.
- Contribute to and influence the development /supply strategy for assigned studies, ensuring that the demand, risks and opportunities for supply optimization are taken into account.
- Create, maintain and communicate dynamic long-range project demand forecast and budget information for assigned clinical compounds/studies. Liaise closely to ensure clear transfer of information to the Vendor group responsible for management of the study budget
- Liaise closely with Quality Assurance (QA) to ensure that all Study Management activities are conducted in accordance with cGMP, GCP, & ICH guidelines.
- Partner with stakeholder departments to identify critical challenges and risks associated with IP supply to the clinic. Communicate and provide input into risk management plans.
- Bachelor’s degree in basic or applied science or engineering and a minimum of 3 years’ experience in Quality Assurance & Compliance; Clinical Trials experience highly preferred.
- Project Management experience in drug development is required.
- Substantial experience in planning and managing all aspects of IMP management for clinical studies, including oversight of vendor management of GMP operations. Have a complete understanding of cGMP, GCP and ICH guidelines as related to IMP management.
- Experience in the Biotechnology and/or Pharmaceutical industry is required and experience in IP management and supply is preferred
- Preferably will have a sound understanding of the drug development process and ideally also experience in the management of cross-functional projects and/or activities.
- Ability to work in a dynamic environment, and collaborate effectively within cross functional teams to deliver complex projects.
- Proficiency in Microsoft Outlook, Word, Excel and PowerPoint is expected.
- This position requires a high level of commitment, flexibility, initiative and an ability to work with minimal direct supervision. The Study Manager must be a highly organized individual who possesses excellent attention to detail, and demonstrates strong skills for planning, coordination, teamwork, and communication.
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
Perks of being a Kelly employee:
- Weekly electronic pay
- Access to more than 3,000 online training courses though Kelly Learning center
- Group rate insurance options available immediate upon hire*
- Service bonus plan and holiday pay*
- Online application system
- Never an applicant fee
•perks to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.
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Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
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