Clinical Manager, Clinops FSP

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Thermo Fisher Scientific

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Biotechnology • Pharmaceuticals • Science

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.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Manages staff, providing coaching, mentorship and work direction. • Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. • Interviews, recruits and selects staff. • Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. • Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. • Ensures timeliness and accuracy of timesheets and expense reports. • Supports allocation activities per the local resourcing process. • Supports activities of project leads/functional leads to optimize the operational running of projects. • Escalates appropriately any issues which may impact project deliverables. • Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. • Identifies training gaps and ensures that training requirements are met. • Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. • Manages and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. • Evaluates work of staff, including conducting MAST visits (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable. • Participates in process improvement/development initiatives. • Ensures understanding and facilitation of the risk based monitoring approach. • May provide input into bids and contribute to the procurement of new business where required.

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). • 1+ year of leadership responsibility • Advanced mentoring/leadership/supervisory skills • Excellent clinical trials monitoring skills; Remote and on-site • Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines) • Demonstrated 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 • Demonstrated use of computer to include data entry, archival and retrieval • Ability to travel as needed • Excellent team player with team building skills • Excellent interpersonal and conflict resolution skills • Advanced ability to utilize problem-solving techniques applicable to constantly changing environment • Solid knowledge of medical/therapeutic areas and medical terminology.

🏖️ Benefits

• Health insurance • 401(k) matching • Paid time off • Flexible working hours • Professional development opportunities