Pharmaceutical Project Manager

The incumbent is responsible for systematically monitoring and evaluating the services and products provided to a multi-clinical trial (MCT) to ensure that the desired level of quality is being met with the primary aim of focusing on process.

• The incumbent plans MCT projects for providing services and producing and distributing clinical materials (drugs, devices, ancillary supplies).

• Works with the Project Director (PD) to determine the scope and documents all related changes to the project’s pharmaceutical design, budget and controls and design targets, goals, and objectives, procedures, action plans and timeframes.

• Uses computer software (e.g., MS Project, etc.) to define and establish the task sequences and milestones to accomplish these major MCTs.

• Identifies the customers (site investigators, nurse coordinators, research pharmacists) that will receive PCC product and services. Identifies any special needs for the project.

• Assists the PD 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.

• Responsible for record-keeping of PCC support to the assigned projects. Designs and implements databases, spreadsheets, and interim reporting systems to manage large MCTs over several years.

• Participates with the PD and management in developing sort-term and long-term strategic planning goals, objectives, action plans and quality process improvement strategies.

• Works with the PD, and Quality Assurance/Regulatory Compliance Specialist and Program Manager of the Biorepository to develop processes for the collection, receipt, processing, storage, retrieval, research use, and destruction of biospecimens.

• Responsible for developing budgets for multiple MCTs, including costs for labor, clinical supplies (drugs, devices, ancillary supplies), laboratory analyses, equipment, packaging and Good Clinical Practice monitoring and auditing.

• Coordinates with internal and external organizations to obtain data and information needed to satisfy regulatory requirements.

• Oversees the workload of the MCT matrix teams within the internal matrix organizational structure to meet time frames and requirements.

5. Knowledge, Skills, & Abilities Preferred:

• Project Management

• Strategic Planning

• Financial Reporting

• Schedule Management

• Compliance Monitoring

• Record Keeping

• Microsoft Office Proficiency

• Customer Relations

• Strong leadership and communication skills

6. Qualifications:

• Bachelor’s Degree or higher in Supply Chain Management, Public Health, Business, Finance, or a field directly related to the duties and responsibilities specified

• Intermediate to advanced level skills in Microsoft Office software suite - Word, Excel, Outlook, PowerPoint

• Strong interpersonal skills and good judgment with the ability to work alone or as part of a team

7. 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, Part 1301.76 which requires that CRPCC not employ 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.

Job Type: Full-time

Pay: $73,317.00 - $83,092.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Ability to Relocate:

• Albuquerque, NM 87106: Relocate before starting work (Required)

Work Location: In person

Salary : $73,317 - $83,092