Clinical Operations Manager

Tessera Therapeutics is seeking a highly experienced Clinical Trial Manager to lead global clinical trials from first-in-human to Phase 3, ensuring operational excellence, compliance, and timely delivery.

About You

• Bachelor’s degree in a relevant scientific or healthcare discipline.
• 8+ years of clinical operations experience, including 4+ years as a clinical trial manager.
• Experience managing global clinical operations for trials from start-up to close-out, including CROs, vendors, budgets, and timelines.
• In-depth knowledge of ICH/GCP guidelines and regulatory requirements.
• Proficiency in trial management systems (IVRS/IWRS, eTMF, EDC, SmartSheets) and Microsoft applications (Project, PowerPoint, Word, Excel).
• FDA or other regulatory inspection experience is a plus.
• Rare disease and/or gene therapy experience is highly preferred.
• Strong project management, cross-functional leadership, and organizational skills.
• Ability to thrive in a fast-paced environment, prioritize tasks, and adapt to changing program needs.

Responsibilities

• Lead day-to-day clinical trial management activities and cross-functional study teams.
• Contribute to the development and presentation of clinical trial operational strategy and updates to leadership.
• Provide input into budget development, timeline management, and baseline budget oversight.
• Identify outsourcing needs and lead the evaluation, selection, and management of global CROs and vendors.
• Review, contribute to, or author study documents (Protocol, Informed Consent Forms, Investigator Brochures, Clinical Study Reports, Regulatory submissions).
• Conduct ongoing trial risk identification, analysis, and mitigation to maintain study deliverables.
• Oversee trial execution to ensure compliance with timelines, budget, operational, and quality standards (ICH/GCP/SOPs).
• Ensure CROs and third-party vendors perform in alignment with study plans and deliverables.
• Lead feasibility assessments for region/country selection, site evaluation, and investigator relationships.
• Develop and oversee patient recruitment and retention strategies, addressing deviations as needed.
• Oversee the development of study-specific documents (site training materials, CRFs, statistical analysis plans, manuals).
• Review clinical trial data and metrics (protocol deviations) to ensure timely resolution of data quality issues.
• Develop, monitor, and manage trial budgets, including proposals, contracts, and scope changes for vendors.
• Provide input on study drug and clinical supplies forecasting; oversee drug accountability and reconciliation.
• Escalate issues related to study conduct, quality, timelines, or budget; develop and implement corrective actions.
• Ensure inspection readiness and support internal audits, external inspections, and CAPAs.
• Oversee TMF setup and maintenance by the CRO.
• Manage study close-out activities (database lock, vendor contract reconciliation, TMF, study drug accountability).
• Ensure compliance with clinical trial registry requirements.

You are an individual with excellent team management abilities, responsible for overall clinical study delivery as the primary point of contact for leadership and oversight. You have demonstrated the ability to partner with internal stakeholders, CROs, and vendors to deliver global trials on time, within budget, and in compliance with ICH-GCP and regulatory requirements.

Benefits

• Group medical, vision, and dental coverage.
• Group life and disability insurance.
• 401(k) plan with company contribution.
• Tuition reimbursement.
• Annual incentive bonus and equity grants.

Pay

Per Year Salary Range: $164,000 - $199,000 USD.