Pharmaceutical Project Manager

Pharmaceutical Project Manager Biomedical Research Institute of New Mexico (BRINM) Albuquerque, NM Job Details Full-time From $75,489 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Vision insurance 401(k) matching Qualifications Record keeping Bachelor's degree Packaging Problem-solving Organizational skills Budget management in healthcare Budget preparation Productivity software Manufacturing Full Job Description The incumbent is a full time, salaried employee of the Biomedical Research Institute of New Mexico (BRINM) and holds an appointment to work at the Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. Responsibilities include, but are not limited to: Managing inventory for clinical trials, which includes study drug products and devices. This includes managing the onsite inventory as well as the inventory at several study sites across the nation and ensuring that sites are adequately stocked. Works with a designated pharmacist in the Division of Study Design and Management. Supports clinical trials by documenting all related changes to the project's design, budgeting and designing targets, goals, objectives, procedures, action plans, and timeframes to meet the project's needs. Coordinates the distribution and production of clinical trial materials and services (drugs, devices, ancillary supplies) for multi-site projects. Tracks the task sequences and milestones of multiple projects simultaneously to accomplish goals and maintains ongoing communication with all stakeholders throughout the studies' life cycles. Maintains ongoing communication with the stakeholders of multiple projects that are geographically separated. Anticipates customer needs and manages issues between stakeholders. Assists in developing the operational aspects of drug/device manufacturing, packaging designs including label design, kit configuration, medication blister cards, defining procedures for randomization and drug/device assignment to research subjects. Designs and implements databases, spreadsheets, and interim reporting systems to manage large projects over several years. Participates in developing short-term and long-term strategic planning goals, objectives, action plans and quality process improvement strategies. Responsible for developing budgets for multiple projects, including costs for labor, clinical supplies (drugs, devices, ancillary supplies), laboratory analyses, equipment, packaging, and shipping. Coordinates with internal and external organizations to obtain data and information needed to satisfy regulatory requirements.

Knowledge, Skills, & Abilities Required:

Project management Inventory management Deliverable and deadline management Budget development Strong written and verbal communication skills Recordkeeping and strong organizational skills Problem solving skills and initiative Intermediate skill level in Microsoft Office.

Qualifications:

Bachelor's Degree in a field related to the duties and responsibilities specified. Two years of professional experience.

Other Significant Facts:

This position is stationed at a facility that maintains an FDA Good Manufacturing Practice (GMP) status and is licensed by the DEA for receipt, manufacturing, packaging, and distribution of controlled substances. Employees must successfully complete a background investigation complying with the requirements of 21 CFR 1301.76 which prohibits the hiring of any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked, or had surrendered a DEA registration for cause. Position may be subject to drug testing.

Pay:

From $75,489.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Vision insurance

Work Location:

In person