Senior Manager, Clinical Operations – FSP

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

📋 Description

• Supervise, train, allocate resources, coach, and manage the performance of a team of clinical operations personnel.

• Drive performance using metrics and key performance indicators.

• Serve as the escalation point for performance-related concerns and training requirements.

• Collaborate with leadership to determine resourcing needs.

• Manage staff while providing coaching, mentorship, and work direction.

• Conduct performance evaluations and career discussions; facilitate employee development.

• Interview, recruit, and select prospective staff members.

• Manage and conduct induction/orientation programs for new hires.

• Maintain updated staff CVs, training records, position profiles, and experience profiles.

• Ensure the timely and accurate submission of timesheets and expense reports.

• Support allocation activities and project/functional leads to enhance project operations.

• Raise any issues that could affect project deliverables.

• Provide training on WPDs, SOPs, local regulations, and clinical operations topics.

• Identify training gaps and ensure compliance with requirements.

• Ensure adherence to ethical and regulatory standards.

• Notify management of quality issues and facilitate or request QA audits.

• Review clinical operations systems including Activate, CTMS, Preclarus, and Clarity to assess metrics, KPIs, and project status.

• Evaluate staff performance, including conducting remote or on-site PAVs.

• Engage in process improvement and development initiatives.

• Ensure comprehension and implementation of risk-based monitoring.

• Provide input on bids and the procurement of new business as needed.

• Collaborate with senior management and executive staff on strategic planning and business development.

• Work with local client/sponsor teams to achieve program KPIs and address issues.

• Lead or contribute to initiatives aimed at enhancing departmental and company-wide performance.

⛳️ Requirements

• Bachelor's Degree in Life Science is preferred.

• Over 12 years of experience in Clinical Monitoring, Trial Management, eTMF management, and Onsite Monitoring-related activities.

• More than 4 years of experience managing CRAs, CTCs, and Project Support Coordinators.

• Experience managing one or multiple FSP Clients as a Single Point of Contact.

• Familiarity with Workflow Allocation, Performance Management, Quality/CAPA, and Reporting activities.

• Willingness to travel to Clinical Trial Sites across India (up to 25% travel required).

• Advanced mentoring, leadership, and supervisory skills.

• Excellent clinical trials monitoring skills, both remote and on-site.

• Understanding of, or ability to learn, the company's SOPs, WPDs, and relevant regulations (e.g., ICH/GCP, FDA guidelines).

• Capability to evaluate medical research data.

• Strong organizational and negotiation skills.

• Exceptional attention to detail.

• Advanced written and verbal communication skills.

• Proficient in English language and grammar.

• Computer skills encompassing data entry, archival, and retrieval.

• Ability to travel as required.

• Team-building, interpersonal, and conflict resolution skills.

• Strong problem-solving skills in a dynamic environment.

• Knowledge of medical/therapeutic areas and medical terminology.

🏝️ Benefits

• Be part of a global team at Thermo Fisher Scientific.

• Opportunities for collaboration and professional development.

• Chance to contribute to scientific excellence and meaningful work.

• Fully remote work arrangement, with travel to clinical trial sites across India up to 25%.