PHARMACY MANAGER

SPAULDING CLINICAL RESEARCH LLC•West Bend, WI

1d•Onsite

About The Position

The Pharmacy Manager is responsible for the overall oversight and complete documentation regarding investigational drug receipt, storage, dispensation, and accountability activities in the conduct of clinical trials at Spaulding Clinical. This role requires providing consistent direction for all pharmacy-related personnel in planning, organizing, implementing, and evaluating clinical research activities. The manager performs all medication management services in compliance with protocol, Standard Operating Procedures (SOPs), regulatory guidelines, and pharmaceutical client’s needs. Key responsibilities include the management of departmental employees, directing and scheduling workload, completing performance appraisals, administering employee-related policies, and ensuring compliance with company policies.

Requirements

Ability to read, write, and interpret the English language.
Demonstrated ability to lead by example and to encourage team members to seek solutions.
Excellent planning and organizational skills.
Demonstrates strong analytical, problem solving skills.
Strong written and verbal communication skills and ability to effectively communicate with Pharmaceutical Sponsors and Clients.
Self-motivated, detail oriented, good organizational traits.
Exceptional computer and specifically Microsoft Office skills; inclination to adopt technology to maximize efficiency.
Must be results oriented, multi-tasking, quick learner, respond to urgent needs of the team and show a strong track record of meeting deadlines.
Basic knowledge and understanding of Quality Systems (SOPs, WI’s, CAPAs, and internal audits).
Basic knowledge and understanding of Employment Laws (FLSA, FMLA, ADA, hiring, termination, and harassment).
Registered Pharmacist or Physician.
Minimum three years of hospital or industry sponsored clinical trials experience.
Valid Wisconsin professional License.
Requires broad knowledge of clinical research and drug development.
Specific and in-depth knowledge of ICH GCP and 21 CFR.

Nice To Haves

Prior IV experience preferred.
Advanced degree preferred.
Success in independent clinical project management preferred.

Responsibilities

Oversees and manages the pharmacy and staff in regard to drug preparation, administration, and inventory under the supervision of the Director of Clinical Operations.
Responsible for all pharmacy-related protocol review, risk management and mitigation planning, and Pharmacy Manual creation or approval for all contracted study activity.
Keeps abreast of SOP’s, ICH/GCP guidelines, NIH guidelines, as well as state and national regulatory requirements.
Available and prepared for Sponsor, CRA, and/or customer pharmacy meetings, audits, and monitoring visits.
Responsible for creating, maintaining, and filing study Pharmacy binders completely and accurately.
Monitors each report's training throughout their training period and makes recommendations regarding progress.
Is present and available onsite to staff during business hours, as well as available by telephone and/or email for urgent needs during non-business hours.
Keeps employees updated on important issues and company objectives through scheduled department meetings and assigns action items, while staying united with Clinical Operations management on quarterly/yearly goals.
Periodically monitors procedures and study specific events to ensure they are being followed correctly and staff is demonstrating competence.
Holds 1:1 Meetings with all reports on a regular basis for oversight, feedback, and career development purposes (monthly for Full-Time/Regular Part-Time staff, quarterly for pool staff).
Supervises departmental employees: responsible for directing and scheduling workload, completing performance appraisals, administering employee-related policies, and ensuring compliance with company policies.
Monitors and reviews all PTO requests, ensuring coverage for all departmental needs.
Responds with appropriate level of urgency to issues raised by staff, prioritizes importance, and resolves issue or delegates as appropriate.
Mentors, trains, and supervises clinical staff to promote growth.
Monitors and contributes oversight and metrics associated with the department, as requested by Manager.
Interacts with other functional managers across multiple areas to facilitate smooth work processes and communication throughout the study process.
Supervises tracking/management of trial progress for Pharmacy to ensure trials are completed per protocol, in accordance with Spaulding and Sponsor project goals, and in accordance with ICH GCP, 21 CFR, and other applicable laws/regulations.
Assists with managing study budgets to ensure internal/external operating costs are closely managed as they pertain to pharmacy departments.
Ensures that all pharmacy and dosing-related supplies are properly ordered and onsite prior to need.
Collaborates with Quality Department to own, develop, maintain, and ensure training and compliance with departmental SOPs and Work Instructions.
Responsible for departmental Quality Metrics and timely reporting of metrics data and presenting of data during management review, as requested by Manager and QA.
Ensures timely investigation and completion of CAPAs.
May assist in departmental internal audits.
Collaborates with HR Department to develop, review, and revise departmental job descriptions.
Collaborates with HR Department on departmental staffing (hiring/transfers/promotions).