Senior Manager, Clinical Operations – FSP

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Oversee, train, resource, coach, and performance-manage a team of clinical operations staff • Lead performance using metrics and key performance indicators • Act as point of escalation for performance concerns and training needs • Collaborate with leadership on resourcing needs • Manage staff and provide coaching, mentorship, and work direction • Conduct performance appraisals and career discussions; facilitate employee development • Interview, recruit, and select staff • Manage and conduct induction/orientation programs for new employees • Maintain staff CVs, training records, position profiles, and experience profiles • Ensure accurate and timely timesheets and expense reports • Support allocation activities and project/functional leads to optimize project operations • Raise issues that may impact project deliverables • Deliver training on WPDs, SOPs, local requirements, and clinical operations topics • Identify training gaps and ensure requirements are met • Assure adherence to ethical and regulatory standards • Alert management to quality issues and request or facilitate QA audits • Review clinical operations systems including Activate, CTMS, Preclarus, and Clarity to evaluate metrics, KPIs, and project status • Evaluate staff work, including conducting remote or on-site PAVs • Participate in process improvement and development initiatives • Ensure understanding and facilitation of risk-based monitoring • Provide input into bids and procurement of new business as required • Collaborate with senior management and executive staff on strategic planning and business development • Work with local client/sponsor teams to meet program KPIs and resolve issues • Lead or contribute to initiatives improving department and company-wide performance

🎯 Requirements

• Bachelor Degree in Life Science is Preferred • 12+ year of Experience in Clinical Monitoring, Trial Management, eTMF management, Onsite Monitoring related activities • Experience managing CRAs, CTCs, and Project Support Coordinators for more than 4+ years • Experience managing one or multiple FSP Clients as Single Point of Contact • Experience in Workflow Allocation, Performance Management, Quality/CAPA, Reporting related activities • Willingness to travel to Clinical Trial Sites across India (up to 25% Travel) • Advanced mentoring/leadership/supervisory skills • Excellent clinical trials monitoring skills; Remote and on-site • Understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines) • Ability to evaluate medical research data • Strong organizational and negotiation skills • Strong attention to detail • Advanced written and oral communication skills • Good knowledge of English language and grammar • Computer skills including data entry, archival, and retrieval • Ability to travel as needed • Team building, interpersonal, and conflict resolution skills • Problem-solving skills in a constantly changing environment • Knowledge of medical/therapeutic areas and medical terminology

🏖️ Benefits

• Global team environment at Thermo Fisher Scientific • Collaboration and development opportunities • Opportunity to contribute to scientific excellence and impactful work • Fully remote work arrangement, with travel to clinical trial sites across India up to 25%