The Regional Pharmacy Manager is responsible to oversee, manage, and train the regional unblinded pharmacy operations and staff to meet study specific trial requirements for each assigned site.

DUTIES & RESPONSIBILITIES

Participation in study start-up activities and identification of pharmacy and regulatory requirements for new incoming studies and protocol amendments.
Communicate and consult with site leadership in regards to IP preparation/administration and blinding procedures to aid in dosing visit timeline and workflow projections.
Oversee the Unblinded Team training and compliance with sponsor/protocol-specific requirements and local/state requirements.
Effective and diligent oversight of IP storage and accountability to ensure secure and restricted access to IP and continuous maintenance of blinding procedures.
Ensure coordination of shipments, delivery, and storage of IP and IP ancillary supplies at each individual site as well as site-to-site transfers.
Ensure proper return and disposal of all unused and used IP in accordance with SOPs, GCP, and FDA.
Review, create, and identify SOPs in regard to IP management and unblinded pharmacy operations.
Provide support and communication with sponsors, auditors, regulatory authorities, and monitors during SIVs, uSIVs, IMVs, and COVs, audits, or site visits.
Mentor and develop unblinded team and leads for optimal performance in regards to CRA/sponsor interactions/communications, quality control on pharmacy documents, and effective time management skills to manage injection request workload.
Provide oversight to Unblinded Teams in regards to the following:
- Temperature monitoring- maintaining logs, calibration records, excursion reporting
- Inventory management – IP and ancillaries
- IP preparation and administration documentation
- IP accountability
Pharmacy Site File maintenance – SBP, training documentation and confirmation/follow-up letters
Ensure new DM sites have a properly trained unblinded team, pharmacy documents, appropriate equipment, and supplies for trials, medications for crash carts.
Maintain a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
Being prepared for and available at all required company meetings.
Submitting required administrative paperwork per company timelines.
Occasionally attending out-of-town Investigator Meetings.
To develop, coordinate, and enforce site-specific systems, policie procedures, and productivity standards.
Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective sites.
Making sure that the most recent versions of the Protocol, Study Manuals, and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s).
Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV.
Ensuring IP management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs, and guidance documents.
Responsible for providing guidance to the site team on planning and monitoring the conduct of the clinical trials.
Coaching, counseling, and disciplining the unblinded staff as applicable.
Collaborating with both internal and external cross-functional stakeholders for the successful conduct and management of assigned protocol(s) at their respective sites.
Any other matters as assigned by management.

KNOWLEDGE & EXPERIENCE

Education:

B.S. in Health Sciences or equivalent required
B.S. in Pharmacy, PharmD preferred

Experience:

3+ years in Clinical Research required
2+ years in Investigational Product Management
Minimum 1 year in managerial or supervisory role

Credentials:

Knowledge and Skills:

Understanding of business development strategies to drive pharmacy growth and profitability
Expertise in inventory control and management to ensure optimal stock levels and minimize wastage
In-depth understanding of pharmacy workflows and processes
Extreme attention to detail (strict adherence to procedures and protocols is essential)
Ability to use computer applications for data capture and for general communication required
Make arithmetical calculations
Exceptional organizational skills to manage multiple pharmacies efficiently
Collaborative approach to working with cross-functional teams and stakeholders
Communicate effectively, both written and verbal
Strong leadership and managerial capabilities
Ability to effectively prioritize and handle multiple tasks within a high-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
Excellent communication and interpersonal skills to effectively collaborate with various stakeholders, including sponsor representatives, healthcare providers, patients, and administrative staff
Ability to effectively build, train and develop new and existing team members