FSP Manager Clinical Operations

Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as Manager Clinical Operations – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As a Manager Clinical Operations, you will oversee, train, resource, coach and performance manage a team, which may be inclusive of various clinical operations focused staff. You will focus on end results using metrics and key performance indicators to lead performance. You will act as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs.

Responsibilities

• You will also work in collaboration with the leadership team for resourcing needs.
• 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.

Requirements

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). • 1+ year of leadership responsibility 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.
• 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 Why Join Us?

Benefits

• When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence.
• You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Knowledge, Skills and Abilities

Apply today to help us deliver tomorrow’s breakthroughs.