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, 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, policies, 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
- 3+ years in Clinical Research required
- 2+ years in Investigational Product Management
- Minimum 1 year in managerial or supervisory role
- N/A
- 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
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