Clinical Project Manager

KlinEra Global Services; San Jose (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

KlinEra Global Services is seeking a seasoned Clinical Project Manager to join our U.S. Clinical Operations team. The role requires 12–15+ years in clinical research and experience leading complex trials, with strategic and operational leadership across studies.

Candidates located in the San Jose/San Francisco Bay Area are strongly preferred. The position involves working with Sponsors and cross-functional teams, managing timelines, budgets, risks, and study deliverables across the full

Qualifications

• 12–15+ years of clinical research experience, with significant experience in clinical project management.
• Experience managing clinical trials across one or more phases of clinical development.
• Experience leading cross-functional clinical study teams.
• Strong experience working directly with Sponsors in a project management capacity.
• Demonstrated ability to manage complex study timelines, budgets, vendors, risks, and deliverables.
• Strong understanding of ICH-GCP and applicable U.S. clinical research regulations.
• Experience working with global or geographically dispersed clinical teams.
• Excellent written and verbal communication skills.
• Ability to travel domestically and internationally as required.

Responsibilities

• Provide overall project management leadership for assigned clinical trials from study start-up through close-out.
• Develop and maintain project plans, study timelines, milestones, deliverables, critical paths, and governance structures.
• Lead study planning and start-up activities, including feasibility, site identification and selection, regulatory submissions, and site activation.
• Lead cross-functional study teams across Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Writing, Medical Monitoring, Pharmacovigilance, Clinical Supplies, and Quality Assurance.
• Serve as a primary point of contact for Sponsors, leading project meetings, communicating study status, managing expectations, and escalating issues as appropriate.
• Manage study timelines and proactively identify potential delays, risks, and mitigation strategies.
• Support study budget management, forecasting, change orders, vendor costs, investigator/site payments, and financial tracking.

Skills

Project management

Cross-functional leadership

Sponsor engagement

ICH-GCP compliance

Budget management

Vendor management

Global clinical teams

Regulatory submissions

Schedule development

Education

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Clinical Research, or related

Advanced degree preferred

Job description

Employment Type: Full-Time / Contract

Department: Clinical Operations / Project Management

About the Role

KlinEra Global Services is seeking an experienced Clinical Project Manager to join our U.S. Clinical Operations team. We are looking for a senior-level clinical research professional with 12–15+ years of progressive experience in clinical research, including significant experience managing complex clinical trials and clinical development programs. This position will provide strategic and operational leadership across assigned clinical studies, working closely with Sponsors and cross-functional teams throughout the clinical development lifecycle.

Candidates located in or around the San Jose / San Francisco Bay Area are strongly preferred.

Key Responsibilities

• Provide overall project management leadership for assigned clinical trials from study start-up through close-out.
• Develop and maintain project plans, study timelines, milestones, deliverables, critical paths, and governance structures.
• Lead study planning and start-up activities, including feasibility, site identification and selection, regulatory submissions, and site activation.
• Lead cross-functional study teams across Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Writing, Medical Monitoring, Pharmacovigilance, Clinical Supplies, and Quality Assurance.
• Serve as a primary point of contact for Sponsors, leading project meetings, communicating study status, managing expectations, and escalating issues as appropriate.
• Manage study timelines and proactively identify potential delays, risks, and mitigation strategies.
• Support study budget management, forecasting, change orders, vendor costs, investigator/site payments, and financial tracking.
• Establish and maintain project risk and issue-management processes, including risk logs, mitigation plans, and escalation pathways.
• Provide oversight of site feasibility, selection, activation, recruitment, monitoring, retention, and close-out activities.
• Monitor patient recruitment and retention performance and collaborate with study teams and sites to address recruitment challenges.
• Oversee external vendors, including central laboratories, imaging vendors, technology providers, logistics partners, and specialty vendors.
• Ensure clinical trial activities are conducted in accordance with applicable regulations, ICH-GCP, protocol requirements, Sponsor procedures, and quality standards.
• Partner with Quality Assurance and functional teams to identify quality risks and support CAPA activities.
• Ensure timely completion and review of project documentation, study plans, meeting minutes, action trackers, project reports, and risk logs.
• Develop and present project status reports covering timelines, milestones, recruitment, budgets, risks, quality metrics, and overall study health.
• Lead study close-out activities, including database lock readiness, site close-out, vendor reconciliation, TMF completeness, financial reconciliation, and lessons learned.
• Identify opportunities to improve clinical trial delivery, operational processes, quality, efficiency, technology utilization, and Sponsor experience.

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Clinical Research, or a related discipline; advanced degree preferred.
• 12–15+ years of clinical research experience, with significant experience in clinical project management.
• Demonstrated experience managing clinical trials across one or more phases of clinical development.
• Experience leading cross-functional clinical study teams.
• Strong experience working directly with Sponsors in a project management capacity.
• Demonstrated ability to manage complex study timelines, budgets, vendors, risks, and deliverables.
• Strong understanding of ICH-GCP and applicable U.S. clinical research regulations.
• Experience working with global or geographically dispersed clinical teams.
• Excellent written and verbal communication skills.
• Strong analytical, organizational, problem-solving, and decision-making capabilities.
• Ability to manage multiple priorities in a fast-paced clinical research environment.
• Ability to travel domestically and internationally as required.

Preferred Therapeutic Experience

Experience in one or more of the following therapeutic areas is preferred:

Oncology | Neurology | Nephrology | IBD / Gastroenterology | Hepatology | Cardiovascular | Respiratory | Dermatology | Endocrinology

Why Join KlinEra?

This position offers an opportunity to play a meaningful role in the continued growth of KlinEra Global Services’ U.S. Clinical Operations organization. You will work directly with global Sponsors and multidisciplinary teams while supporting clinical development programs across multiple therapeutic areas. This role is particularly well suited for an experienced Clinical Project Management professional who enjoys combining hands‑on project leadership, Sponsor engagement, strategic problem-solving, and global clinical study execution.

U.S. Work Authorization

Applicants must be currently authorized to work in the United States. KlinEra Global Services is unable to provide employment visa sponsorship for this position. Candidates must therefore be able to maintain valid U.S. work authorization without current or future sponsorship from KlinEra.