Senior Investigator Initiated Trial (IIT) Operations Manager
Astellas Pharma US, Inc.
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Astellas is announcing a Senior IIT Operations Manager opportunity in our Northbrook, IL location!
The Senior Investigator Initiated Trial (IIT) Operations Manager is responsible for providing logistical and tactical project management support for investigator sponsored trials across product portfolios in two or more Therapeutic Areas. Provides project management leadership and expertise to the IIT Committees and collaborates with Scientific Affairs Therapeutic Area Director and Medical Directors to ensure implementation and execution of activities and quality deliverables as defined by the IIT Process. Manages the IIT internet portal, directing submissions to appropriate Medical Directors within ASMA. Serves as principle spokesperson for the IIT process interfacing with key functions to integrate the IIT Process into ASMA business and stake holder objectives; to include change management of IIT process and database, documentation materials and training. This person meets with key investigators, MSLs and internal stakeholders to manage questions and serve as spokesperson about the IIT process and portal. This position requires close collaboration with the TA Medical Director, SA Team Leaders, MSL, and the Therapeutic Area Director for management and execution of IITs from concept submission to study closure. The Sr IIT Operations Manager will assess and train MSLs and investigators on the IIT process and portal including one on one and field based meetings as directed by the Medical Director, Associate Director Operations, and Therapeutic Area Directors.
Primary Duties & Responsibilities include:
- Provide project management for Scientific Affairs' (SA) Investigator Initiated Trials program:
- Work closely with SA Therapeutic Area Directors (TAD) and Medical Affairs Clinical Outcomes (MACO) to ensure IITs are aligned with the Product Strategy Plan.
- Monitor IIT portal for new submissions. Review and route to appropriate Medical Director for evaluation.
- Schedule IIT Committee meetings, pre committee meetings and ad hoc IIT related meetings at the discretion of the Medical Director or the Associate Director of Operations.
- Prepare IIT meeting agenda, minutes and ad hoc reports within the guidelines of the IIT process.
- Manage, monitor and report on study timelines, milestones, regulatory and publication status of IITs.
- Identify, track and report variance to budget and other product-level metrics
- Facilitate working meetings for budget monitoring, process improvements and database updates.
- Exercise clinical trial management skills to include development of a budget, reconciliation of budget items and study contract negotiations.
-Works closely with and provides direction to Scientific Affairs Associates to ensure that payments are processed in SAP, drug estimates are created, drug is ordered, packaged, labeled , accounted for and destroyed and studies are quality assured per the IIT Process.
-Assist in the creation of process improvements and help lead organizational change; share and adopt best practices to improve cross-functional competencies as related to the IIT Process.
- Works closely with key investigators and MSLs to ensure understanding and compliance to IIT process including one on one and field based meetings to ensure knowledge and adherence to business rules and operating procedures.
- The responsibilities of Sr. IIT Manager include a portion of a portfolio of over 400 Investigator Initiated Trials in five therapeutic areas, encompassing 10 products and a budget of over $7.6 million. The Sr. Manager ensures adherence of ASMA staff to the IIT Process, assisting in the creation, identification and tracking of the IIT budget and product-level metrics. Auditing compliance of SA and MACO staff including field based observation, assessment and guidance to the IIT Policy and Business Rules; identifying process improvements, IIT database and portal updates.
- Minimum of a Bachelor's degree in the clinical sciences.
- Minimum of 10 years of experience with a BA or BS OR minimum of 7 years of experience with a MS OR minimum of 5 years of experience with a MD, PhD, Pharm D in the pharmaceutical industry or related fields.
- Proven Project Management experience.
- Demonstrated ability to manage multiple projects and competing priorities.
- Demonstrated high level of competence with MS Office applications, Sharepoint, Documentum and Microsoft Office applications. Ability to gain a good working knowledge of the IIT database.
- Excellent collaboration and communication skills to facilitate team discussions and drive optimal team performance.
- Clinical and/or pharmaceutical study management experience.
- Demonstrated knowledge and understanding of research protocols and study design.
- Proficient in developing reports for leadership oversight.
- Strong interpersonal skills (verbal and written) with a high degree of analytical ability, communication skills, conflict-resolution skills, organization and planning skills, accounting and computer skills particularly with Microsoft Word and Excel.
- Ability to monitor expenditures, maintain data and confidentiality.
- Ability to meet timelines that may require a flexible work schedule.
- Clinical and/or pharmaceutical study management experience within the therapeutic area of oncology.
- Previous experience managing Investigator Initiated Trials and knowledge associated compliance guidelines.
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