Clinical Operation Manager, FSP

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🕒 Julho 2

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• 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. • Raises 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. • May contribute to development of training programs, where appropriate. • Assures adherence to good ethical and regulatory standards. • Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. • Handles 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 PAVs (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. • Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. • May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

🎯 Requisitos

• 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.

🏖️ Benefícios

• Health insurance • Professional development opportunities