Regional Pharmacy Manager

DM CLINICAL RESEARCH GROUP•Houston, TX

About The Position

The Regional Pharmacy Manager oversees, manages, and trains regional unblinded pharmacy operations and staff to meet study-specific trial requirements at assigned sites. The role supports investigational product (IP) management from study start-up through closeout, ensures compliance with study protocols and applicable regulations, and coordinates with site teams, sponsors, auditors, regulatory authorities, monitors, and other cross-functional stakeholders. The manager also develops site-specific systems, policies, procedures, and productivity standards, while coaching and developing unblinded staff and leads.

Requirements

B.S. in Health Sciences or equivalent required.
At least 3 years of clinical research experience required.
At least 2 years of Investigational Product Management experience.
At least 1 year in a managerial or supervisory role.
Understanding of business development strategies to drive pharmacy growth and profitability.
Expertise in inventory control and management to maintain optimal stock levels and minimize wastage.
In-depth understanding of pharmacy workflows and processes.
Extreme attention to detail and strict adherence to procedures and protocols.
Ability to use computer applications for data capture and general communication.
Ability to make arithmetical calculations.
Exceptional organizational skills to manage multiple pharmacies.
Collaborative approach to working with cross-functional teams and stakeholders.
Effective written and verbal communication skills.
Strong leadership and managerial capabilities.
Ability to prioritize and manage multiple tasks in a fast-paced environment.
Excellent organizational and time-management skills.
Analytical and problem-solving skills to identify and resolve complex pharmacy-related issues.
In-depth knowledge of investigational product management and applicable regulatory requirements.
Strong communication and interpersonal skills for collaboration with sponsor representatives, healthcare providers, patients, and administrative staff.
Ability to build, train, and develop new and existing team members.

Nice To Haves

B.S. in Pharmacy or PharmD preferred.

Responsibilities

Participate in study start-up activities and identify pharmacy and regulatory requirements for new studies and protocol amendments.
Consult with site leadership on IP preparation, administration, blinding procedures, dosing-visit timelines, and workflow projections.
Oversee training and compliance of the Unblinded Team with sponsor- and protocol-specific requirements and local and state requirements.
Oversee secure IP storage and accountability, restricted access, and maintenance of blinding procedures.
Coordinate IP and ancillary-supply shipments, deliveries, storage, and site-to-site transfers.
Ensure return and disposal of used and unused IP in accordance with SOPs, GCP, and FDA requirements.
Review, create, and identify SOPs related to IP management and unblinded pharmacy operations.
Support and communicate with sponsors, auditors, regulatory authorities, and monitors during SIVs, uSIVs, IMVs, COVs, audits, and site visits.
Mentor and develop unblinded team members and leads in sponsor and CRA communications, pharmacy-document quality control, and time management for injection-request workloads.
Oversee temperature monitoring, including logs, calibration records, and excursion reporting; inventory management for IP and ancillaries; IP preparation and administration documentation; IP accountability; and Pharmacy Site File maintenance.
Ensure new DM sites have a trained unblinded team, appropriate pharmacy documents, equipment and trial supplies, and crash-cart medications.
Maintain working knowledge of FDA regulations, ICH-GCP guidelines, organizational SOPs, guidance documents, and assigned study protocols.
Attend required company meetings, submit administrative paperwork on company timelines, and occasionally attend out-of-town Investigator Meetings.
Develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards.
Ensure visit preparedness for relevant sponsor and CRO visits and timely follow-up on action items at assigned sites.
Ensure current protocol, study manuals, and other relevant study documents are used and implemented at assigned sites.
Work with cross-functional and site teams to ensure study-start readiness and completion of relevant staff training before FPFV.
Oversee IP management from FPFV through study closeout in accordance with protocols, study documents and manuals, ICH-GCP, FDA regulations, ALCOA-C standards, organizational SOPs, and guidance documents.
Guide site teams in planning and monitoring clinical-trial conduct.
Coach, counsel, and discipline unblinded staff as applicable.
Collaborate with internal and external cross-functional stakeholders to support successful conduct and management of assigned protocols at assigned sites.
Perform other duties as assigned by management.