Clinical Operations Manager

• Independently carry out diverse pharmacy functions to support DAIT Pharmacists with all aspects of clinical studies and the operations of the Investigational Product Procurement Center (IPPC).
• Provide operational support to DAIT Pharmacy Program Lead and Contracting Officer’s Representative (COR) with DAIT Clinical Product Center (CPC) contract and duties.
• Communicate with over 100 clinical sites gathering required information such as site Investigational Product (IP) inventories of expired and unexpired products for DAIT Pharmacist to evaluate, maintain and improve IP management.
• Perform IP procurement, receiving, transferring, tracking of cost savings and providing necessary documents to DAIT Pharmacy program lead, OPPOSI and grants management.
• Independently work with pharmacists in the development and/or review of pharmacy specific documents (e.g. Pharmacy Establishment Plans, Pharmacy Guidelines, Manual Templates and etc.) and standard operating procedures of relevance to DAIT Pharmacy Program activities.
• Independently review and approve Pharmacy Establishment Plans. This includes interacting with DAIT Pharmacist(s) and outside stakeholders.
• Create workflow and project management tools to track key milestones and/or identify potential problems associated with the review of Protocols, Pharmacy Manuals, Site Trainings, Pharmacy Establishment Plans (PEPs), Temperature Deviations, Drug Ordering and Shipments, Drug Purchasing & Approvals, Pharmacy forms processing and other study related projects and tasks.
• Create study-specific customized PDF fillable forms: Accountability record forms, IP order forms, IP return forms, IP destruction forms, Participants-specific treatment accountability record forms, etc.
• In compliance with CFR 21 Part 11 and ICH E6 and GCP requirements and policies, they will assist DAIT Pharmacy program initiatives with all essential pharmacy documents that need to be sent to DAIT/NIAID Trial Master files.
• Independently work to maintain and update DAIT CPC monthly agenda and manage monthly meetings.
• Assist CPC COR with cost and financial tracking and updating relevant spread sheets.
• Serve as an information resource and manage SharePoint Pharmacy folders and point of contact for resolving user problems.
• Independently create quarterly Pharmacist assignment evaluation based on pharmacy and protocol prioritization at DAIT.
• Review site pharmacy monitoring reports and discuss any issues with Pharmacist(s) to note and create the resolution and action plan with the site pharmacist(s) and study team.
• Participate in site visits, as needed, to evaluate the facility, equipment, pharmacy personnel, and infrastructure capacity and provide report as needed.
• Participate in Division meetings and assist DAIT Pharmacy Programs with coverage for the DAIT/ NIAID Clinical Trials’ full group meetings and provide summaries as needed.
• Participate in protocol team or clinical research site conference calls with direction from DAIT pharmacist.
• Work with DAIT pharmacists in the development and formatting of protocol specific trainings for site pharmacists, which may include Power Point presentations, Manual of Operations and fillable PDF forms.
• Develop, review and revise processes and procedures for Pharmacy operations (e.g. SOPs, work instructions, guidance documents, etc.), in coordination with Pharmacy Program Lead.
• Edit, rewrite, and/or proofread drafts of materials prepared by DAIT pharmacists, as needed.
• Assist with data collection needed for ongoing pharmacy program inititiatives, quality assurance evaluation, and internal audits.

Qualifications

• Bachelor’s degree in a health or science related discipline.
• Minimum of four (4) years of experience in clinical research or a related field.
• Certified Pharmacy Technician.
• Hospital pharmacy experience preferred; however, retail pharmacy experience considered.
• Knowledge or proficiency with the implementation or utilization of USP Guidance Chapters 795, 797, and 800.
• Knowledge of Good Pharmacy Practice, Good Clinical Practice, and Human Subjects Protection.
• Ability to work independently and display self-motivation in all aspects of work.
• Ability to function effectively and diplomatically as part of a team.
• Ability to identify issues that need special attention and bring those to DAIT Pharmacist(s).
• Proficient in communicating effectively orally and in writing.
• Excellent analytical, organizational and time management skills.
• Expertise in MS Office including Word, Excel, PDF, Outlook, and PowerPoint.