Clinical Program Manager – Global Study Lead

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the Global Study Lead and main Clinical Operations contact for a significant, worldwide Phase 3 study from initiation to completion.

• Oversee global study planning and execution, which includes initiation, enrollment, site management, and continuous study operations through CRO partners.

• Ensure oversight of CROs and external vendors, maintaining alignment on priorities, timelines, deliverables, quality, risks, and overall study performance.

• Collaborate with cross-functional stakeholders to facilitate successful study execution while identifying, mitigating, escalating, and resolving operational risks and challenges.

• Create and manage study timelines, enrollment forecasts, operational strategies, budgets, and essential study metrics.

• Provide consistent updates to internal stakeholders and senior leadership regarding study progress, risks, mitigation strategies, and decision-making.

• Review critical study documents and supervise monitoring activities, study quality, and the upkeep of study documentation and systems.

• Assist in ensuring inspection and audit readiness, adhering to regulations, ICH-GCP, SOPs, and study-specific protocols.

• Lead or manage Clinical Operations personnel as necessary.

• Set personnel objectives, conduct interim evaluations, and communicate Akero and Novo Nordisk policies and procedures effectively.

⛳️ Requirements

• A minimum of 8+ years of pertinent clinical research experience along with a BS, BA, or BN in a relevant scientific field, or at least 8+ years of clinical research experience paired with an RN (2 or 3 year certificate).

• Relevant experience in clinical trials supporting large, global Phase 3 studies or programs in the pharmaceutical, biotechnology, or healthcare sectors.

• Proven experience in regional study oversight, CRO/vendor management, and operational performance.

• Background in supporting clinical trial inspection and audit readiness, including the identification and correction of operational or documentation deficiencies.

• Strong operational, problem-solving, and risk management capabilities with exceptional attention to detail.

• Comprehensive knowledge of FDA/EMA regulations, ICH guidelines, and GCP requirements.

• Excellent communication and collaboration abilities, with a proven capacity to work effectively across global, cross-functional teams.

• Willingness to travel up to 25%.

🏝️ Benefits

• Company bonus based on individual and company performance.

• Long-term incentive compensation.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Life insurance.

• Disability insurance.

• 401(k) savings plan.

• Flexible spending accounts.

• Employee assistance program.

• Tuition reimbursement program.

• Group legal insurance.

• Critical illness insurance.

• Identity theft protection.

• Pet insurance.

• Auto/home insurance.

• Sick time policy.

• Flexible vacation policy.

• Parental leave policy.