Pharmacy Manager

IQVIA•San Antonio, TX

7d•$88,200 - $220,300

About The Position

The IDS Pharmacy Manager oversees investigational drug services (IDS) for clinical research and oncology care. The role requires knowledge of standard pharmacy practices, including USP<797> and USP<800>, research, and oncology care. The manager advocates for patient safety and protocol integrity, follows patient-care standards, and communicates effectively to support clinical trials and quality patient care. The position also evaluates, hires, trains, supervises, and provides guidance to IDS staff. The manager reviews protocols and amendments for feasibility and compliance, prepares study-specific training and documentation, screens concomitant medications, and coordinates with interdisciplinary teams. The role reviews medication orders and patient eligibility, oversees preparation and checking of investigational and conventional products, and provides pharmaceutical care and drug information. It also manages investigational product inventory, accountability, storage, returns, and disposal; monitors IDS procedures and records; and supports study monitoring visits and audits. Administrative duties include developing and monitoring procedures and workflows, overseeing inventory and workload documentation, contributing to corrective and preventive action plans, and conducting or contributing to staff performance reviews. The manager orients staff, residents, and students; maintains required licenses, certifications, and training; and supports the scanning and uploading of records in eDOCs and use of Vestigo for investigational product and protocol management.

Requirements

Current pharmacy license in the state where the NEXT Oncology position is located.
Current IV certification.
Current chemotherapy certification.
Working knowledge of good clinical practice (GCP), good manufacturing practice (GMP), USP<797>, USP<800>, and applicable procedures, legislation, or national guidelines related to aseptic preparation, hazardous medication dispensing, and clinical trials.
Maintain pharmacy licensure, required certifications, continuing education, protocol-compliance training, and sterile and hazardous compounding certification.

Nice To Haves

Current pharmacy preceptor license in the state where the NEXT Oncology position is located.

Responsibilities

Review potential future protocols for feasibility and attend weekly protocol review meetings and site initiation visits.
Participate in quality-control checks for study-specific forms for new studies and protocol updates.
Create and update IDS-specific staff training documents for protocols and protocol or investigational product manual updates.
Review investigational protocols, amendments, and clarification letters; update medication screening notes, diaries, study-specific forms, Varian Regimens, and Vestigo as needed.
Communicate with interdisciplinary teams to support protocol compliance and timely protocol-related procedures.
Screen concomitant medications for patients being considered for clinical trials and answer medication questions from research staff and patients.
Ensure evidence-based symptom management is provided when permitted by the protocol.
Review medication orders and dose calculations for accuracy, and assess patient-specific treatment eligibility, including laboratory values, protocol assessments, consent status, and toxicity resolution.
Develop compounding tools for IV investigational agents and train technicians in preparation of investigational and conventional agents as required.
Check IV and oral doses prepared by IDS pharmacy technicians.
Support a high-quality investigational drug service and provide pharmaceutical care responsive to research staff and patient needs.
Provide drug information to physicians, nurses, and other healthcare professionals.
Manage investigational product inventory, including ordering, receipt, storage, returns, and disposal.
Maintain accurate protocol records, including accountability, receipt, temperature monitoring, expiration or retest dating, and staff training.
Review oral investigational product medication diaries and returns with treatment-room nurses and research coordinators; document the review in Vestigo and ensure diaries are uploaded to eDOCs.
Monitor daily IDS activities for adherence to protocols, SOPs, workflows, dispensing procedures, and applicable GCP, GMP, and regulatory requirements.
Assist with monitoring visits and respond to monitor queries.
Directly supervise, train, and provide guidance to IDS pharmacists and pharmacy technicians, including technician preparation of medications and compounding of IV, hazardous, and oral investigational products.
Ensure IDS staff are trained and comply with NEXT Oncology SOPs and workflows.
Contribute to the development, integration, and monitoring of written IDS procedures and workflows.
Oversee monthly conventional inventory, investigate discrepancies, and make adjustments as required; monitor inventory record maintenance.
Cover for other IDS employees during illness or scheduled PTO, including compounding duties.
Collect and document workload statistics and provide other data as required.
Contribute to corrective and preventive action plans for unanticipated problems, deviations, violations, and noncompliance.
Conduct annual reviews for IDS pharmacists and provide input to pharmacy technician performance appraisals.
Assist the VP of Investigational Drug Services with preparation and review of audit documentation.
Orient IDS staff, pharmacy residents, and pharmacy students to IDS protocols and responsibilities as required.
Maintain continuing education and requirements for pharmacy and preceptor licenses, certifications, and protocol-compliance training, including GCP and PHRS; maintain sterile and hazardous compounding certifications.
Assist with scanning, reviewing, and uploading protocol documentation and employee resumes, licenses, certifications, and training records into eDOCs.
Become knowledgeable in and use Vestigo for investigational product and protocol management.