Clinical Team Manager – Senior

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

📋 Description

• Oversee all clinical operational and quality components of assigned studies, which range from moderate to high complexity, ensuring compliance with ICH GCP standards.

• Create clinical tools (such as Monitoring Plans and Monitoring Guidelines) in collaboration with the Data Quality Plan.

• Work alongside the project manager to prepare, organize, and deliver presentations at client meetings, including bid defense and hand-off sessions.

• Partner with the clinical team and other departments as necessary to fulfill project deliverables.

• Take charge of implementing and training standardized clinical monitoring processes throughout the study.

• Ensure the completion of the final clinical deliverable within the specified contractual timeframe.

• Communicate with study sites regarding matters such as protocol adherence, patient involvement, case report form completion, and other study-related concerns.

• May oversee all start-up activities and ensure that the quality of essential documents meets the expectations of the Regulatory Compliance Review.

⛳️ Requirements

• Bachelor's degree or an equivalent relevant formal academic/vocational qualification.

• Prior experience that equips the candidate with the knowledge, skills, and abilities to perform the role (approximately 8+ years).

• Preferred background: experience in a STM role and/or prior involvement in non-interventional/Phase IV studies/RWE studies.

• Strong leadership capabilities, effective at mentoring and training, with the ability to inspire and integrate teams.

• Excellent planning and organizational abilities to facilitate effective prioritization of personal and team workload.

• Strong interpersonal and problem-solving skills essential for working in a multicultural matrix organization.

• Solid grasp of change management principles.

• Comprehensive knowledge of the practices, processes, and requirements associated with clinical monitoring.

• Strong judgment, decision-making, escalation, and risk management abilities.

• Effective oral and written communication skills, including proficiency in the English language.

• Ability to assess personal and team workload against project budgets and adjust resources as needed.

• Strong financial insight and knowledge of budgeting, forecasting, and fiscal management.

• Exceptional attention to detail.

• Deep understanding of relevant regulations, such as ICH/GCP, FDA guidelines, etc.

• Proficient computer skills for effectively utilizing automated systems and applications like Outlook, Excel, Word, etc.

• Capable of independently managing clinical-only studies.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options