Clinical Study Manager
One MedImmune Way Gaithersburg, MD 20878
Clinical Study Manager
• Plan and manage all aspects of Investigational Product (IP) supply for assigned clinical studies
• Work collaboratively within Logistics and Clinical Supply (LCS) to provide seamless deliver of Vendor, Distribution and Systems management activities
• Liaise 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.
• Contribute to the operational effectiveness of Logistics and Clinical Supply Major Duties and Responsibilities
• Plan and manage IP supply for assigned clinical studies.
The Study Manager will typically be responsible for management of multiple studies involving diverse development compounds. Studies may be domestic and /or international in scope and will include more complex operations such as associated with later stage trials, or in provision of comparator reagents o Using defined tools and procedures create documentation required to support IP supply activities. Examples include overall budget and timelines, packaging & labeling plans, IP kit list specifications, distribution plans, returns & reconciliation plans, and IP handling instructions such as IP manual o Provide IP input into all relevant study related documents and activities. Examples include Clinical study protocols, Investigator Brochure, Clinical Study Report, Regulatory documents (such as packaging configuration and approved label text for IMPD), investigator site training materials, and IXRS specifications (including user acceptance testing, system approval and on-going system updates) o Maintain IP study documentation in defined document repositories, as appropriate and ensure all documentation is current, accurate and complete. o Submit necessary IP related documentation to the Product Specification File. o 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. Represent these activities at the Supply Continuity Team (SCT) o Create, develop and maintain LCS agreed clinical supply strategy for IP o Agree scope of work, and more detailed plans and timelines with Systems, Distribution and Vendor Management representatives and collaborate to achieve agreed supply activities o Collaborate in ensuring responsiveness to changes in supply remit and in LCS review and resolution of issues and challenges as they arise,
• As a member of the SCT 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
• Represent LCS at the Clinical Trial Team (CTT). Ensure good information exchange in relation to current supply activities, influence for effective and timely consideration of any change scenarios that may impact supply plans, and ensure dynamic interface with the SCT to align planning and implementation of any agreed changes
• Maintain and expand close cross-functional relationships to support and enable activities associated with IP release (e.g. Quality Assurance, ABC and Regulatory). This includes activities such as kit activation and confirmation of release in the appropriate study systems (e.g. IXRS, PMD)
• 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
• Attend and actively participate in departmental meetings
• Participate where required in LCS departmental and/or assigned cross-functional process improvement initiatives
• Apply own unique training and expertise to effectively fill and deliver against flexible assignments within other aligned LCS roles as required (such as within the Program Management, Distribution or Vendor Management teams)
• Mentor, develop and supervise the daily activities of other members of LCS assigned to flexible roles within the Study Management team
• In addition, where required, mentor, develop and supervise the activities of direct reports, and/or Study Management Specialists who may be assigned to partner in delivery of more complex study assignments.
• Communicate effectively with assigned teams, BPD, and with all interfacing functions and relevant groups as required
*** Clinical Trials experience is a nice to have
*** PM experience in drug development is needed
*** Minimum of 3 years experience in Quality assurance & compliance background
Requires a Bachelor’ s degree in basic or applied science or engineering.
The Study Manager will have appropriate direct experience working in a development or technical operations environment in the pharmaceutical, scientific or health care product industry. Specific experience in IP management and/or supply is desirable.
• 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 Special Skills/Abilities 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.
Proficiency in Microsoft Outlook, Word, Excel and Power Point is expected.