Manager, Clinical Operations

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

📋 Description

• Oversee the integration of project team activities by utilizing both internal and external resources, expertise, and knowledge, while optimizing CRO resources and capabilities.

• Contribute to operational strategies at the trial level for clinical studies, spanning from protocol design to the final clinical study report for designated projects.

• Offer insights into global subject and patient recruitment strategies.

• Manage relationships between study sites and vendors.

• Handle the identification of CROs and vendors, along with the daily operational management of CROs and other vendors, which includes setup, creation of statements of work, and budget oversight.

• Direct strategic study operations, including the management of study sites and tracking systems for regulatory submissions, drug supply and utilization, subject enrollment, regulatory document flow, study timelines, budgetary and financial data, performance metrics, and data flow.

• Develop and revise essential trial-specific documents (for instance, country-specific informed consent forms) and plans.

• Assist in the creation of compound and protocol-level training materials.

• Review and provide insights on budgets, timelines, and forecasts for assigned clinical trials.

• Collaborate with key internal stakeholders, which may include Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, and Medical Affairs; potentially acting as a liaison among these groups.

• Support activities related to inspection readiness and assist in identifying risks and developing mitigation plans at the trial level.

• Engage in process improvement initiatives at both the trial and departmental levels as necessary.

⛳️ Requirements

• A BS/BA degree is mandatory.

• A minimum of 5 years of clinical research experience in a CRO, Biotech, or Pharmaceutical setting, specifically involving Phase 1-4 global clinical trials.

• At least 2-3 years of experience leading global clinical trial components.

• Proven experience in working with a CRO.

• Extensive regulatory knowledge, including Good Clinical Practices (GCPs).

• Strong analytical, decision-making, and financial management skills are crucial for this role.

• Demonstrated ability to enhance team productivity and cohesion, with the capacity to operate and execute independently.

• Experience in leading without direct authority in multifunctional, matrixed, and global environments.

• Background in mentoring and coaching others.

• Outstanding organizational skills with the ability to manage competing priorities, along with strong reasoning and problem-solving capabilities.

• Proficient in project planning and management, with excellent communication (both written and verbal) and presentation skills.

• Experience in the development and review of protocols, informed consent forms, case report forms, and clinical study reports.

• Proficient in MS Office Suite (Excel, Word, and PowerPoint).

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.