Team Lead, Site Operations

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

📋 Description

• Act as the primary line manager for designated Site Operations staff, including Clinical Trial Associates, Clinical Research Associates, Clinical Trial Managers, and other assigned positions.

• Recruit, onboard, mentor, develop, and retain team members effectively.

• Establish individual objectives, offer performance feedback, conduct evaluations, and facilitate career development, succession planning, and promotion readiness.

• Foster an environment of trust, accountability, inclusion, and psychological safety while addressing any performance or conduct issues.

• Ensure team members uphold necessary training, qualifications, competencies, and functional knowledge.

• Collaborate with Clinical Operations Leads to clarify study roles, priorities, timelines, and deliverables; act as an escalation point and gather study-performance feedback.

• Lead resource forecasting and manage workload balancing across studies.

• Allocate or reallocate Site Operations personnel to studies based on portfolio priorities, competencies, workload, continuity needs, and development opportunities.

• Identify capacity gaps and suggest hiring, contractor support, capability development, or other resource solutions.

• Own, develop, maintain, and harmonize Site Operations and Clinical Operations processes, SOPs, work instructions, guidance documents, templates, and training materials.

• Ensure uniform application of Clinical Operations processes and standards across studies and regions while considering local requirements in Germany and the United States.

• Promote continuous improvement and global harmonization by leveraging lessons learned, recurring issues, metrics, audit and inspection observations, CAPAs, and user feedback.

• Establish and track functional metrics and KPIs related to Site Operations, resource utilization, process quality, and organizational effectiveness.

• Support organizational change, technology adoption, and process enhancements.

• Maintain advanced knowledge of ICH GCP, regulations, clinical monitoring practices, and industry standards.

• Facilitate inspection and audit readiness, including personnel, processes, documentation, oversight evidence, and corrective and preventive actions.

• Provide subject matter expertise for site management, clinical monitoring, monitoring strategies, oversight models, and related Site Operations processes.

• Collaborate with Clinical Operations Leads and cross-functional partners to identify systemic risks, process gaps, and capability needs.

• Exemplify transparent communication, reliable execution, sound judgment, and collaborative leadership throughout the global Clinical Operations organization.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field is required.

• 8 to 10 years of experience in Clinical Operations or related roles within the biotech or pharmaceutical sectors.

• 4 to 5+ years of direct leadership experience managing clinical operations professionals.

• Candidates must be authorized to work in the United States without requiring current or future sponsorship.

• Successful completion of a background check, reference checks, and pre-employment drug screening, as permitted by applicable law.

• A Master's degree in Life Sciences, Pharmacy, Nursing, or a related discipline is preferred.

• 5+ years of clinical monitoring experience within the pharmaceutical or biotechnology industry, including roles as a Clinical Research Associate and/or Clinical Trial Manager.

• Proven experience in late-phase oncology trials.

• Experience in cell therapy or other complex investigational therapies is strongly preferred.

• Strong working knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements.

• Ability to lead cross-functional initiatives and influence stakeholders at various organizational levels.

• Experience managing resources, priorities, and competing business demands in a dynamic environment.

• Proven track record of driving operational improvements and implementing innovative strategies within Clinical Operations.

• Experience supporting regulatory inspections and audit preparedness activities.

🏝️ Benefits

• Competitive rates for Health, Dental, and Vision Insurance.

• 4 weeks of vacation, awarded upfront each year and prorated for the first and last year of employment.

• 12 company-paid holidays.

• 7 days of sick time.

• 100% employer-paid life insurance up to 1x annual salary, capped at one hundred thousand dollars.

• 100% employer-paid short- and long-term disability coverage.

• 401(k) with immediate eligibility and company matching.

• Company match of 100% of contributions up to 3% of base salary for the first two years, 4% for years 2-3, and up to 5% from the fourth year onward.

• Partially paid parental leave for eligible employees.

• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, critical illness insurance, identity theft protection, and pet insurance.

• Remote work arrangement.