Project Manager, Clinical Operations US (On-site and/or Remote)

REV Clinical; Bakersfield (CA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

REV Clinical is seeking an experienced Project Manager to independently lead and oversee the operational execution of domestic and global clinical trials. You will serve as the primary contact for sponsors and internal cross-functional teams, ensuring timelines, quality, budget, and patient enrollment targets are achieved.

The role requires strong client-facing skills and a proactive leadership style, with extensive CRO experience across Phase I–IV, preferably in Oncology.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related scientific discipline.
• Minimum of 5 years of clinical research experience.
• Minimum of 5 years of project management experience within a CRO, pharmaceutical, or biotechnology environment.
• Demonstrated experience independently managing clinical trials from startup through database lock and closeout.
• Experience serving as the primary client-facing project lead.
• Strong understanding of clinical trial operations, budgeting, forecasting, and risk management.
• Knowledge of ICH-GCP, FDA regulations, and international clinical research standards.
• Proven ability to manage multiple projects simultaneously.
• Excellent written, verbal, and presentation communication skills.
• Must be legally authorized to work in the United States.

Responsibilities

• Independently lead one or more Phase I-IV clinical studies from study startup through closeout.
• Serve as the primary operational contact for sponsors, investigators, sites, and internal teams.
• Develop and maintain comprehensive project plans, timelines, study forecasts, and risk mitigation strategies.
• Ensure project milestones, deliverables, and quality standards are achieved according to client expectations and contractual obligations.
• Lead study team meetings and drive accountability across cross-functional departments.
• Monitor study progress and identify operational risks, proposing solutions before issues impact timelines or quality.
• Support inspection readiness and ensure that projects are conducted in accordance with applicable regulations and company SOPs.

Skills

Project management

Client-facing

Cross-functional leadership

ICH-GCP knowledge

Budgeting & forecasting

Education

Bachelor’s degree in Life Sciences

Job description

P OSITION DESCRIPTION

Company

REV Clinical (formerly CBCC Global Research)

REV Clinical is seeking an experienced and highly motivated Project Manager to independently lead and oversee the operational execution of domestic and global clinical trials. The Project Manager serves as the primary point of contact for sponsors and internal cross-functional teams and is accountable for achieving study objectives related to timelines, quality, budget, and patient enrollment.

This role requires a proactive leader with strong project management expertise, exceptional client-facing skills, and demonstrated success managing Phase I-IV clinical studies within a CRO environment. Experience in Oncology is strongly preferred, with additional experience in Neurology, Ophthalmology, or Rare Disease considered a strong asset.

The ideal candidate thrives in a fast-paced, entrepreneurial environment and is passionate about delivering clinical trials with reliability, excellence, and velocity.

Location

On-site and/or Remote

Company Background

REV Clinical (formerly CBCC Global Research), headquartered in Bakersfield, California with additional operations in Ahmedabad, India and Australia is a leading, multi-national clinical contract research organization with deep experience in designing and managing clinical trials across a range of therapeutic areas, including Oncology, CNS, and Ophthalmology. REV Clinical provides end-to-end CRO services — spanning clinical study design, project management, data analysis, regulatory strategy and medical writing— across Phase I–IV clinical trials for leading biopharmaceutical companies.

Role: Project Manager, Clinical Operations

REV Clinical is seeking an experienced and highly motivated Project Manager to independently lead and oversee the operational execution of domestic and global clinical trials. The Project Manager serves as the primary point of contact for sponsors and internal cross-functional teams and is accountable for achieving study objectives related to timelines, quality, budget, and patient enrollment.

Key Responsibilities

Clinical Trial Leadership & Execution

• Independently lead one or more Phase I-IV clinical studies from study startup through closeout.
• Serve as the primary operational contact for sponsors, investigators, sites, and internal teams.
• Develop and maintain comprehensive project plans, timelines, study forecasts, and risk mitigation strategies.
• Ensure project milestones, deliverables, and quality standards are achieved according to client expectations and contractual obligations.
• Lead study team meetings and drive accountability across cross-functional departments.
• Monitor study progress and identify operational risks, proposing solutions before issues impact timelines or quality.
• Support inspection readiness and ensure that projects are conducted in accordance with applicable regulations and company SOPs.

Sponsor & Client Management

• Build strong working relationships with sponsor teams and serve as a trusted strategic and operational partner.
• Provide regular project status updates, study metrics, risk assessments, and executive summaries.
• Lead sponsor meetings, governance discussions, and project reviews.
• Support proposal development, scope discussions, and change order management as needed.
• Participate in bid defense meetings and business development opportunities when requested.
• Manage project budgets, forecasts, and financial performance.
• Monitor revenue recognition, study burn rates, and overall project profitability.
• Review project resourcing needs and collaborate with departmental leadership to ensure appropriate staffing.
• Identify potential scope changes and support timely change order development.

Cross-Functional Leadership

• Coordinate activities across Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Safety, and Vendor Management.
• Ensure alignment among internal and external stakeholders.
• Mentor Clinical Trial Managers, Clinical Research Associates, and junior team members where appropriate.
• Contribute to process improvement initiatives and operational best practices.

Quality & Compliance

• Maintain thorough knowledge of ICH-GCP guidelines and applicable FDA and global regulations.
• Ensure protocol compliance and adherence to project plans.
• Support CAPA activities, audit responses, and quality initiatives as needed.

Qualifications

Required

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related scientific discipline.
• Minimum of 5 years of clinical research experience.
• Minimum of 5 years of project management experience within a CRO, pharmaceutical, or biotechnology environment.
• Demonstrated experience independently managing clinical trials from startup through database lock and closeout.
• Experience serving as the primary client-facing project lead.
• Strong understanding of clinical trial operations, budgeting, forecasting, and risk management.
• Knowledge of ICH-GCP, FDA regulations, and international clinical research standards.
• Proven ability to manage multiple projects simultaneously.
• Excellent written, verbal, and presentation communication skills.
• Must be legally authorized to work in the United States.

Preferred

• Oncology clinical trial experience strongly preferred.
• Experience in Neurology, Ophthalmology, or Rare Disease research.
• Global or multi-country study management experience.
• Early-phase (Phase I/II) experience.
• PMP certification or equivalent project management certification.
• Experience participating in sponsor audits and regulatory inspections.

Key Competencies

Leadership

• Leads with accountability and ownership.
• Builds trust across sponsors, sites, and internal teams.
• Influences without direct authority.

Communication

• Communicate effectively with sponsors, investigators, and senior leadership.
• Provides clear, concise, and actionable project updates.
• Demonstrates strong presentation and facilitation skills.

Problem Solving

• Anticipates operational challenges and develops practical solutions.
• Uses data and metrics to drive decision-making.
• Maintains focus and effectiveness in a dynamic environment.

Client Focus

• Demonstrates a high level of responsiveness and professionalism.
• Builds long-term sponsor relationships.
• Consistently delivers on commitments.
• Thrives in a dynamic, growing entrepreneurial organization.
• Balances strategic thinking with hands‑on execution.
• Remains flexible in a fast‑paced project environment.