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Responsibilities
Reviews incoming IIR requests and documents for accuracy and completeness and/or enters requests into IIR systems, including uploading and scanning, as directed by IIR Managers. Contacts requestors for missing or requested documentation, as directed by IIR Managers. Prepares required correspondence to IIR requestors and Pfizer colleagues, including acknowledgement letters to requestors and communications to Review Committee members, RMRS, Regional, or PCO colleagues. Manages distribution of documentation, preparation of agendas, and required scheduling coordination necessary for Review Committee meetings, as directed by IIR Managers. Forwards appropriate IIR request data to Contracts & Outsourcing and reviews initial contracts created for correspondence with initial request, as directed by IIR Managers. Assists IIR Managers in generating Clinical Supply Requests and coordinating with Clinical Supply to ensure clinical supplies are available as required for IIR studies. Manages the transactional details of payment requests and documentation with Finance, NASS or other appropriate Pfizer colleagues, as directed by IIR Managers and works with them to resolve payment processing issues. Inputs IIR study milestones into the IIR system. Assists in the regular generation of requests to investigators for enrollment sweeps and study progress updates, and forwards documents received to IIR Managers. Uploads final documentation received from requestors and closes completed studies in the IIR systems. Assists IIR Managers with status report queries, as required. Contributes to process and technology improvement projects within areas of responsibility, as requested.
Requirements
Bachelors degree Experience with Grant Management. Working knowledge of the principles and concepts of Investigator Initiated Research based on experience in Clinical Study or IIR study management, or a related discipline. General knowledge of drug product(s), disease characteristics, and research or study design. Adept at the use of computer based tools and systems (e.g., tracking, financial, clinical supply, investigator credentialing, document management, etc.) used to support IIR study management. Assumes responsibility, with supervision, for selected parts of study(ies) (e.g., drug supply forecasting & ordering, patient enrollment, tracking). Completes study-specific tasks and contributes to the delivery of milestones. Identifies when issues are beyond own expertise and seeks input from appropriate team members (e.g., more senior colleagues). Performs assignments using established procedures and general instruction on the process and desired outcome. Makes decisions that require choosing between limited options to resolve moderately complex problems. Responds appropriately to routine questions raised by RMRSs, PCOs, and other internal stakeholders. Correctly interprets and executes routine application of SOPs and processes. Makes appropriate decisions related to maintaining a high level of data integrity and process compliance. Exercises judgment utilizing standard methods and techniques. Assumes responsibility for, and organizes, a portion of a study’s milestones and deliverables. Identifies when issues are beyond own expertise and seeks input from appropriate team members (e.g., more senior colleagues). Respectfully challenges decisions or ideas to uphold integrity and ethical standards. With limited support, reliably completes defined study responsibilities (e.g., enrollment tracking, drug re-supply). Contributes to process and technology improvement projects within area of responsibility. Develops effective and productive partnerships within the individual’s area of responsibility to aid in delivery of project goals. Participates and contributes as an IIR study team member. Shares best practices and strives for continuous improvement. Takes responsibility for a portion of the IIR study team’s milestones and deliverables (e.g., conducting enrollment sweeps). Works with other team members proactively to identify moderately complex problems on specific IIR study(ies) and helps determine solutions.