$80K — $100K *
Director, Pharmacy Operations
The Director, Pharmacy Operations is responsible for the overall management, supervision and coordination of the Pharmacy Operations team and handling of Investigational and Non-Investigation Products (IP/NIP). The Director, Pharmacy Operations will ensure the handling of IP, NIPs and pharmacy activities performed by the Pharmacy Operations team are executed in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs).
· Management of the Pharmacy Operations team, including but not limited to, PTO management, timesheet approval, on-going and yearly performance reviews, employee hiring, disciplinary actions and termination.
· Oversee, manage and/or coordinate the training and training records for the Pharmacy Operations team.
· Proactively assess learning opportunities for the Pharmacy Operations team.
· Implement and foster a culture around the organization’s core values and advocate positive, team driven relationships across departments.
· Produce, trend and escalate key performance indicators and take corrective action when required.
· Ensure pharmacy facility equipment and staffing is adequate to accomplish pharmacy activities within protocol requirements and clinical trial timelines.
· Ensure and/or perform quality review of pharmacy documentation, including but not limited to, IP/NIP labels, Active Pharmaceutical Ingredient (API), inventory.
· Ensure the creation of and/or maintain pharmacy and inventories as well as pharmacy maintenance logs such as, , cleaning and calibration.
· Participate in protocol reviews and sponsor meetings; communicate recommendations and advise on specific IP regulations and/or preparations.
· Assist and or participate in sponsor visits and regulatory audits and ensure the timely resolution to any related findings.
· Assist in the revision of pharmacy related SOPs.
· Oversee and/or perform IP preparation (i.e. reconstitution, solutions preparation under aseptic techniques).
· Answer IP and/or pharmacy process related queries in a time efficient manner.
· May act as Randomization Officer.
· May act as QPIC or A/QPIC for controlled substances and maintain the permanent inventory to ensure compliance pharmacy licensure limitations.
· Enforce restricted access and the appropriate documentation of all in and out movement of controlled substances.
· Act as an ambassador for cross-site collaboration and alignment.
· Other tasks as assigned by Departmental Management.
Internal: All level of employees throughout the organization
External: Vendors, Participants, Sponsors, Regulatory Agencies, Candidates
Degree from Accredited School of Pharmacy and demonstrated leadership involvement required. Experience in Phase 1 clinical research preferred.
In depth knowledge of GCPs and applicable regulations pertaining to clinical trials performed on human
volunteers. Exceptional organization, leadership, communication and problem solving skills. Innovative, creative, detail-oriented, people-oriented.
Valid through: 11/12/2021
$80K — $100K *
10 days ago
$140K — $160K *
8 days ago