Phase I Clinical Trials Manager

Qualifications

• Bachelor's Degree in Life Sciences, Healthcare, Nursing, or a related field.
• 5+ years of experience in clinical research, clinical operations, or clinical trial management.
• Experience managing Phase I, Phase II, or early development clinical trials.
• Strong project management and vendor management experience.
• Demonstrated knowledge of clinical trial operations, clinical research methodologies, GCP and ICH guidelines, regulatory compliance requirements.
• Excellent communication, organizational, and stakeholder management skills.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Clinical Trial Management: Lead and oversee the operational execution of assigned clinical trials from startup through closeout; develop, maintain, and manage study timelines, milestones, and deliverables; monitor study progress and provide regular status updates to leadership and key stakeholders; support protocol development, protocol amendments, and operational feasibility assessments.
• Vendor & CRO Oversight: Manage and oversee contract research organizations (CROs) and external vendors, including data management/EDC, central laboratories, imaging & central readers (MRI, ECG, etc.), IVRS/IWRS systems, home health nursing networks, clinical supply packaging & distribution, pharmacovigilance providers, global CRO partners; participate in CRO and vendor selection processes; monitor vendor performance and ensure deliverables are met according to project timelines and quality standards.
• Cross-Functional Collaboration: Partner with pharmaceutical sponsors, trial leadership teams, investigational sites, and subject matter experts to support successful study execution; coordinate activities across Clinical Operations, Biomarker, Imaging, Biostatistics, Regulatory Affairs, Data Management, and other functional groups; facilitate communication and issue resolution among stakeholders.
• Quality & Compliance: Ensure studies are conducted in accordance with GCP, ICH Guidelines, FDA Regulations, Code of Federal Regulations (CFR), applicable local regulatory requirements, company SOPs; identify operational and quality risks and implement mitigation plans; support inspection and audit readiness activities.
• Site Management & Enrollment Support: Partner with CRO teams to address site performance and enrollment challenges; support recruitment strategy development and implementation; participate in investigator meetings and study-related training activities.
• Clinical Supply Management: Collaborate with pharmaceutical partners and vendors to ensure timely drug supply availability; monitor inventory levels, expiration dates, and supply forecasting.

Pay

The pay range for this position is $43.26 - $55.28/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position (contract position based out of St. Louis, MO).

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record