Clinical Research Program Manager

Clinical Research Program Manager

Kelly Science & Clinical is seeking a Clinical Research Program Manager for a Direct Hire opportunity supporting research site client. If you are an experienced clinical research leader who is dedicated to advancing high-quality research, upholding Good Clinical Practice, and thriving in a fast-paced, professional environment, trust The Experts at Hiring Experts to guide your next career move.

This on-site leadership role oversees the operational execution, quality, and growth of a portfolio of industry-sponsored clinical trials, primarily within neurology and neurodegenerative disease research. The Clinical Research Program Manager will lead Clinical Research Coordinators, drive study startup and execution, build productive sponsor/CRO relationships, and support expansion of the clinical trial pipeline.

What You'll Do

• Lead day-to-day operations for a portfolio of Phase IIV industry-sponsored clinical trials, from feasibility and startup through closeout.
• Directly supervise, train, mentor, and develop a team of Clinical Research Coordinators.
• Assign study responsibilities based on protocol complexity, workload, participant volume, and coordinator experience.
• Monitor enrollment, participant visits, data quality, protocol deviations, monitoring findings, sponsor requests, and operational risks.
• Ensure studies are appropriately staffed, inspection-ready, and conducted in alignment with protocols, ICH-GCP, FDA regulations, IRB requirements, sponsor expectations, and site SOPs.
• Lead operational startup activities, including feasibility assessments, site qualification and initiation visits, workflow development, training plans, and cross-functional readiness.
• Partner with regulatory, laboratory, pharmacy, nursing, investigator, vendor, budget/contract, and administrative teams to prepare studies for enrollment.
• Serve as a senior point of contact for sponsors, CROs, monitors, and study vendors; address requests and resolve operational concerns promptly.
• Support business-development efforts by evaluating potential studies, completing feasibility questionnaires, participating in site-selection activities, and maintaining sponsor/CRO relationships.
• Develop recruitment, prescreening, enrollment, and retention strategies with study teams and leadership.
• Identify opportunities to strengthen workflows, training materials, SOPs, quality practices, and scalable research operations.
• Support sponsor audits, CRO audits, internal quality reviews, CAPA activities, and regulatory inspection readiness.

Required Qualifications

• Bachelor's degree in health, science, clinical research, business, or a related field; an equivalent combination of education and substantial clinical research experience may be considered.
• At least 5 years of progressively responsible clinical research experience.
• Demonstrated experience independently managing industry-sponsored interventional clinical trials.
• Experience across clinical trial startup, enrollment, monitoring, data quality, protocol compliance, and closeout.
• Prior experience supervising, mentoring, training, or leading Clinical Research Coordinators or comparable research staff.
• Strong working knowledge of FDA-regulated clinical research, ICH-GCP, informed consent, protocol adherence, source documentation, and data-integrity standards.
• Experience communicating directly with pharmaceutical sponsors, CROs, monitors, and investigators.
• Current Good Clinical Practice and Human Subjects Protection training.
• Current ACRP certification, such as ACRP-CP, CCRC, or CCRA.
• Ability to work fully on-site in Spokane, Washington.

Preferred Qualifications

• Seven or more years of progressive clinical research experience.
• Prior experience as a Clinical Research Manager, Program Manager, Site Manager, Lead CRC, or similar leadership role.
• Experience in neurology, movement disorders, Parkinson's disease, Huntington's disease, multiple system atrophy, essential tremor, or other neurodegenerative conditions.
• Experience with Phase I or other operationally complex clinical trials.
• Experience with sponsor outreach, feasibility assessments, site selection, or clinical research business development.
• Experience leading startup across multiple concurrent studies.
• Experience supporting FDA inspections, sponsor audits, CAPAs, or formal quality-management and inspection-readiness programs.
• Additional certification through ACRP, SOCRA, or another recognized clinical research organization.

Skills for Success

• Strong leadership, coaching, communication, and relationship-management skills.
• Ability to translate complex protocols into practical site workflows and study plans.
• Excellent project-management, organization, prioritization, and problem-solving abilities.
• Comfortable managing multiple studies, team priorities, sponsor relationships, and competing deadlines.
• Proficiency with EDC systems, sponsor portals, CTMS/eSource platforms, EMR systems, Microsoft Office, and electronic scheduling tools.
• Strong commitment to participant safety, confidentiality, ethical research conduct, data integrity, and continuous improvement.

Work Environment

This is a primarily on-site role in a professional clinical research setting. The position involves frequent interaction with participants, caregivers, investigators, coordinators, sponsors, CROs, monitors, vendors, and internal leadership. Some travel and occasional protocol-driven early morning, evening, or weekend work may be required.

Interested candidates should apply directly to this job posting.