Clinical Research Pharmacy Project Manager

Kelly Science, Engineering, Technology & Telecom; Bethesda (MD); On-site; USD 120,000 - 170,000; Full time

Job summary

Kelly Government Solutions in Bethesda, MD, supports NIH with a Clinical Research Pharmacy Project Manager who oversees pharmaceutical operations, protocol development, and regulatory oversight across complex studies.

This role partners with investigators and multidisciplinary teams, ensures FDA, DAIDS, and international compliance, and drives study product management, site readiness, and scientific writing.

Qualifications

• Doctor of Pharmacy (PharmD) or equivalent advanced pharmacy degree.
• Experience supporting clinical research studies or pharmaceutical development.
• Knowledge of FDA regulations, GCP, and clinical research operations.
• Strong project management, analytical, and organizational skills.
• Excellent written and verbal communication, including scientific writing.

Responsibilities

• Review, plan, and implement clinical trials with cross-functional teams.
• Evaluate study design, feasibility, and pharmaceutical requirements.
• Develop and review study-specific SOPs and operations manuals.
• Forecast study product needs and manage pharmaceutical calculations.
• Monitor project progress and provide status updates to leadership.
• Support regulatory compliance and investigator communication.

Skills

Project management

Regulatory compliance

Clinical research

Pharmaceutical operations

GCP knowledge

Education

Doctor of Pharmacy (PharmD)

Job description

Clinical Research Pharmacy Project Manager

Kelly Government Solutions, supporting the National Institutes of Health (NIH)

Advance Clinical Research That Changes Lives

Kelly Government Solutions is seeking a highly skilled Clinical Research Pharmacy Project Manager to support pharmaceutical and clinical trial operations for the National Institutes of Health (NIH). This role combines project management, pharmaceutical expertise, clinical research support, and regulatory oversight to ensure the successful development and execution of complex clinical research studies.

The ideal candidate will have experience supporting clinical trials, pharmaceutical operations, protocol development, and cross-functional research teams in a highly regulated environment.

Key Responsibilities

Clinical Trial & Protocol Support

• Participate in the review, planning, and implementation of clinical trials.
• Evaluate study design, feasibility, pharmaceutical requirements, and operational considerations.
• Identify and resolve pharmaceutical and logistical challenges that may impact protocol execution.
• Develop and review study-specific operations manuals and standard operating procedures.
• Create and maintain project management documentation and tracking tools.

Pharmaceutical Expertise & Regulatory Support

• Serve as the pharmaceutical subject matter expert on multidisciplinary protocol teams.
• Advise investigators and protocol teams on pharmaceutical requirements, FDA regulations, DAIDS standards, and international compliance requirements.
• Develop study intervention sections of clinical protocols, including pharmaceutical administration and product management requirements.
• Provide guidance regarding pharmacy operations, investigational product management, and protocol implementation.

Study Product Management

• Forecast study product needs based on sample size, dosing requirements, formulations, accrual rates, and study duration.
• Prepare Study Product Request Letters for leadership review and submission to pharmaceutical manufacturers.
• Perform pharmaceutical calculations involving compounding, dilutions, aliquots, and product preparations.
• Support pharmaceutical product availability assessments and management throughout protocol conduct.

Project Management & Research Administration

• Monitor project progress and provide status updates to leadership.
• Evaluate project activities and provide recommendations for improvement.
• Develop and track project budgets and funding requirements.
• Assist with grant proposal preparation and funding requests.
• Research and implement project management best practices and industry standards.
• Provide project management expertise to support strategic decision-making and resource allocation.

Scientific Writing & Publications

• Contribute to scientific manuscripts, reports, and publications.
• Review and edit research findings for publication in peer-reviewed journals.
• Collaborate with investigators and research teams to communicate study results.

Clinical Site Support & Oversight

• Conduct site visits to assess pharmacy infrastructure, capabilities, and research readiness.
• Review pharmacy monitoring reports and recommend priorities for clinical site monitoring activities.
• Evaluate Pharmacy Establishment Plans and collaborate with site pharmacists to ensure compliance and readiness.
• Develop and deliver protocol-specific training for pharmacists and clinical staff using web-based training platforms and other educational tools.

Stakeholder Collaboration

• Serve as a liaison among federal staff, investigators, pharmacists, pharmaceutical manufacturers, and clinical research sites.
• Participate in protocol development meetings, network meetings, and scientific review committees.
• Ensure pharmaceutical concerns identified by review committees and regulatory stakeholders are addressed appropriately and efficiently.

Required Qualifications

• Doctor of Pharmacy (PharmD) or equivalent advanced pharmacy degree.
• Experience supporting clinical research studies, clinical trials, or pharmaceutical development programs.
• Knowledge of FDA regulations, investigational products, Good Clinical Practice (GCP), and clinical research operations.
• Experience with protocol development, study implementation, and pharmaceutical management.
• Strong project management, analytical, and organizational skills.
• Excellent written and verbal communication skills, including scientific writing experience.
• Ability to work collaboratively with multidisciplinary teams in a fast-paced research environment.

Preferred Qualifications

• Experience supporting NIH, federal research programs, DAIDS, NIAID, or other government-funded clinical research initiatives.
• Experience in infectious disease, oncology, immunology, or related research areas.
• Project Management Professional (PMP) certification or equivalent project management experience.
• Experience training clinical site personnel and developing educational materials.

Why Kelly Government Solutions?

For more than 20 years, Kelly Government Solutions has partnered with the NIH to provide scientific, technical, and clinical research professionals supporting groundbreaking discoveries that improve human health worldwide.

Join a mission-driven team and contribute to clinical research that advances science, develops innovative therapies, and improves patient outcomes for future generations.