Senior Clinical Program Lead

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

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