Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a global healthcare and clinical research company supporting pharmaceutical and biotechnology clinical trials. The Manager, Clinical Operations in FSP oversees, trains, coaches, resources, and performance-manages clinical operations staff while ensuring adherence to SOPs, WPDs, ethical and regulatory standards, quality requirements, and project performance objectives.

Responsibilities

• 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

Skills

• 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 teammate 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
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

Benefits

• Fully remote work arrangement
• Coaching and mentorship
• Employee career development
• Induction/orientation programs for new employees
• Training on Working Practice Documents (WPDs), Standard Operating Procedures (SOPs), local requirements, and other clinical operations subjects
• Collaboration and development as part of the everyday experience

Company Overview

Company H1B Sponsorship