Phase I Clinical Trials Manager

Actalent; St. Louis (MO); Remote; USD 123,984,000 - 158,399,000; Full time

Job summary

Actalent is seeking a Phase I Clinical Trials Manager to lead the operational execution of early‑stage trials from startup through closeout. You will coordinate with CROs, vendors, and trial sites to ensure timelines, deliverables, and feasibility are met in a fast‑paced environment.

The role requires a bachelor’s degree in life sciences and 5+ years in clinical research or trial management, with strong GMP/ICH knowledge and stakeholder communication.

Qualifications

• 5+ years of experience in clinical research, clinical operations, or trial management.
• Experience managing Phase I, Phase II, or early development trials.
• Strong project management and vendor management experience.
• Knowledge of GCP, ICH guidelines, and regulatory requirements.
• Excellent communication, organizational, and stakeholder management skills.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Lead and oversee operational execution of trials from startup to closeout.
• Develop, maintain, and manage study timelines, milestones, and deliverables.
• Monitor study progress and provide status updates to leadership.
• Support protocol development and amendments and feasibility assessments.

Skills

Project management

Vendor management

Clinical trial operations

Clinical research methodologies

GCP/ICH guidelines

Regulatory compliance

Communication & stakeholder management

Multitasking in fast-paced environment

Education

Bachelor's Degree in Life Sciences, Healthcare, Nursing, or related field

Job description

Phase I Clinical Trials Manager

Required 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.

Key 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:

• Good Clinical Practice (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.

Job Type & Location

This is a Contract position based out of St. Louis, MO.

Pay and Benefits

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.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: 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.

Application Deadline

This position is anticipated to close on Oct 20, 2026.

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 (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.