IIR Jr. Program Manager
- The oversight and management of Investigator Initiated Research (IIR) programs within assigned Therapeutic Area(s).
- This will be in support of at least two or more Medical Teams in the Business Units and/or Research Units that review and approve research proposals from independent investigators in the corresponding therapeutic areas
- Ensures the timely review of IIR proposals, contract generation and execution, and forecasts and coordinates drug shipments across the program globally
- Oversees study progress and collaborates with IIR Associates to ultimately ensure compliance with IIR processes, systems and regulations
- Liaises externally with Principal Investigators, research sites, co-op groups, relevant government agencies (e.g., NIH, NCI), drug safety monitoring boards, alliance partners, and vendors.
- The IIR Program Manager is the primary Point of Contact for Company colleagues, including TA Medical Teams (within the Business Units and Research Units), RMRSs, PCOs, and Regions, PGRD, Worldwide PharmSci, Contracts & Outsourcing, Safety & Risk Management, Outcomes Research, Project Management, Legal, Regulatory, and Finance.
- Monitors the IIR-related systems and educational needs of internal and external stakeholders to maintain compliance with Company’s IIR policies and guidelines as well as external healthcare law throughout the process
- Champions operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve IIR functions globally across an asset program
- Maintain Organizational Relationships with TA Medical Teams (within the Business Units and Research Units), RMRSs, PCOs, and Regions, PGRD, Worldwide PharmSci, Contracts & Outsourcing, Safety & Risk Management, Outcomes Research, Project Management, Legal, Regulatory, and Finance
- Collaborates with TA colleagues in the management of the global budget for IIR studies, providing expertise and informs decisions on financial forecasting.
- Collaborates with Team leads on the allocation of work of IIR Associates, whether FTE or contractors, on larger studies or asset programs (as appropriate)
- Manages IIR requests from reception to close
- Supervises initial review for completeness and classification of IIR proposals, entry of information into the IIR system, acknowledgment communications, and requests for additional information or documentation through the entire lifecycle of assigned IIR studies
- Directs PCO colleagues who are completing the IIR submissions in INSPIIRE to address missing information and ensures compliance to Company’s policies on Safety Reporting, FCPA, HCP and Privacy
- Liaises with Business Units, Research Units, and Asset teams on IIR proposals, especially those that will require or more sophisticated handling for review and decision. (e.g., proposals from co-operative groups or partnerships)
- Updates study details and changes in supply and funding in the IIR system, managing all approvals as required
- Collaborates with IIR Associates, as required, in processing complex studies with IIR and clinical trial or sponsored study components
- Coordinates and facilitates IIR Review Committee(s)
- Informs IIR Review Committees (for two or more assets) about meeting schedules and agendas and oversees document preparation for meetings
- Manages and facilitates meetings of IIR Review Committees for two or more assets, which review and make decisions about IIR proposals
- Ensures appropriate and efficient follow-up of Review Committee action items and decisions
- Collaborates with internal and external partners and stakeholders
- Responds to queries about the status of assigned IIR proposals, studies, and IIR policies and procedures from RMRS, PCOs & Regions, Medical Teams, BUs/RUs and other internal and external stakeholders, as required
- Interacts directly with Principal Investigators, research sites, co-operative groups and public or private sector intergroups and networks in the US or worldwide to facilitate the Medical review process and execution of IIR studies within assigned TA and to ensure compliance with IIR policy, global and local healthcare laws
- Works with the PCO, Training, & Systems Liaison to communicate and resolve inquiries from internal and external stakeholders regarding the requirements of multi-site or multi-country studies
- Coordinates with the PCO, Training, & Systems Liaison to manage relationships with PCO and Regional colleagues as required for management of IIR proposals globally
- Works with the External Partner Liaison to process IIR requests and resolve issues and queries from internal or externals stakeholders regarding co-op or partnership group studies
- Works with Reporting and Analytics Lead to provide detailed summaries and reports for asset or TA leadership and informs decisions on the management of IIR programs
- Mediates in the generation of IIR contracts
- Facilitates and monitors the efficient and accurate creation of contracts and amendments for IIR studies – new or ongoing – with Contracts & Outsourcing, Legal, and Regulatory colleagues
- Secures and manages clinical supplies and vendors
- Forecasts study drug supply requirements, and initiates requests for clinical supply
- Works with PharmSci colleagues to maintain adequate drug supplies, including pooled supplies when feasible and appropriate
- Manages study drug supply inventories, and ensures timely deliveries to sites
- Monitors study milestones and requests for additional supply and funding
- Manages financial payments and tracks study progress and close
- Initiates initial and milestone payments, as appropriate, working with MBO Finance and NASS to ensure accuracy and timeliness.
- Conducts enrolment sweeps on a regular basis to track patient enrolment and study progress
- Resolve payment issues raised by investigators or other stakeholders in cooperation with MBO Finance, NASS or other internal stakeholders, as required
- Evaluates study progress reports and results for overall compliance and recommends corrective action or study termination for non-performance
- Secures study results, required documentation, and publications from completed studies, forwards them as appropriate for Medical review, and implements Close procedures
- Applies and provides training in IIR operational strategies and compliance regulations
- Adheres to applicable SOPs, written standards, working practices, and implementation guidelines for the IIR process, as required and contributes to their development
- Trains RMRS, PCO, and Regional colleagues on IIR policies, procedures, and systems, as directed by the Global IIR PCO, Training, & Systems Liaison
- Participates in task forces to evaluate and continuously improve IIR processes and systems, as required and shares best practices
- Provides end-to-end management of IIR processes for multiple asset programs from review to implementation and close
- Brings results to the appropriate attention of Medical to demonstrate ROI
- May serve as an SME for a specific activity related to continuous improvement (e.g., SOP or process)
- Makes decisions that require choosing between multiple options to resolve complex problems
- Makes decisions based on a high degree of integrity to ensure compliance of IIR Review Committees with applicable healthcare laws and regulations
- Makes decisions that impact the quality and timelines of the work and contributing efforts of other internal stakeholders across Company and external stakeholders (investigators institutions, etc.).
- Serves as global point of contact for RUs / BUs for given asset programs for advice and solutions; makes correct decisions based upon a mixture of analysis, wisdom, experience and judgment
W2 ONLY!!!! No Corp to Corp!!!
- Minimum of a BS/BA is required with preference for a focus in science or biomedical discipline (Candidates with equivalent experience as defined below may be considered)
- Masters degree, Advanced education and/or training/experience preferred
- 4-7 Years Microsoft Word experience
- Level will be determined by candidate’s background and qualifications
- Prior Experience in investigator-initiated research or clinical study management is required
- Demonstrated effectiveness in working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
- Strong knowledge of Therapeutic Area(s), subject matter expertise and international experience are desirable
- Strong working knowledge of the scientific and operational issues relevant IIR to study design, drug product(s), disease characteristics, and relevant scientific and operational aspects of drug development
- Solid understanding of GCP, HCL, Regulatory, Safety, and laws applicable to IIR studies
- Comprehensive knowledge of appropriate Company SOPs, processes and systems
- Good understanding of other functional areas (e.g., Clinical Supply, Finance, C&O) and organizations (e.g., RMRS, Company Country Offices and Regions including U.S.)
- Experience with financial and IIR drug supply forecasting
- Adept at the use of computer based tools and systems (e.g., tracking, financial, document management, etc.) used to support IIR study management (i.e. IIR system).
- Excellent written and oral communication skills
- Excellent project management skills; capable of managing two or more IIR asset programs at the same time
- Knows when to escalate issues to IIR leadership
IIR Jr. Program Manager
| Employment Type:
| Base Pay:
| Other Pay:
||Competitive salary based of years of experience
Other Great Industries
||4 Year Degree
||4 to 7 years
| Manages Others:
| Required Travel:
| Job ID:
Townsend & Associates, Inc.
Townsend & Associates, Inc. provides cutting edge staffing solutions to Fortune 500 companies. Our belief is understanding the culture and needs of our client and matching that criteria with the perfect candidate, thus establishing Townsend & Associates, Inc. as the staffing firm both clients and professionals turn to first.
Since our inception, we have been passionate, motivated, and committed to providing the best overall experience to our clients.
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