FSP Associate Manager Clinical Operations

Regulatory Toolkit; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking an Associate Manager Clinical Operations to lead a team of clinical operations personnel, provide coaching, and ensure effective resourcing, training, and performance development. You will collaborate with senior management on strategic planning and drive execution across monitoring modalities and environments.

Responsibilities include inducting new staff, maintaining training and qualification records, overseeing project allocation, and driving process

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 0-5 years of related experience; 1+ year of leadership responsibility.

Responsibilities

• Manage induction/orientation programs for new employees.
• Ensure staff CVs and training records are up-to-date.
• Support allocation activities and optimize project operations.
• Escalate issues affecting project deliverables.
• Deliver training on WPDs and SOPs and identify gaps.
• Participate in process improvement initiatives.
• Manage risk-based monitoring understanding and application.
• Oversee QA audits and audit responses.
• Review systems to evaluate metrics and project status.
• Manage staff hiring, salary actions, and time/expense approvals.

Skills

Leadership

Induction & Training

Resource Planning

Performance Management

Staff Coaching

Education

Bachelor's degree

Tools

CTMS

Preclarus

Clarity

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an Associate Manager Clinical Operations - Make an Impact at the Forefront of Innovation

The Associate Manager Clinical Operations oversees the daily line management responsibilities of the assigned team. This role serves as a positive leadership and professional role model for respective staff, which may include CAS, CS, CRAs, RSMs, PAs (if applicable), and other clinical operations-focused personnel. The Associate Manager Clinical Operations provides direct coaching and development support to operational teams and is ultimately responsible for effective resourcing, alignment, training, and ongoing professional and technical development for staff. The role involves collaboration with clinical operations senior management and executive staff on strategic planning and business development is required. The primary focus is on the line and performance management of team members assigned to any monitoring modality and/or environment (e.g., FSO, FSP, Government). The Associate Manager Clinical Operations acts as the point of escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. Additionally, the Associate Manager Clinical Operations works in collaboration with the leadership team to address resourcing needs.

What You'll Do:

• Manage and conduct induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
• Ensure all staff CVs, training records, position profiles and experience profiles are complete and up-to-date.
• Support allocation activities per the local resourcing process. Support activities of project leads/functional leads to optimizing the operational running of projects.
• Escalate appropriately any issues which may impact project deliverables.
• Deliver training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations. Identify training gaps and ensure that training requirements are met.
• May contribute to development of training programs, where appropriate.
• Participate in process improvement/development initiatives.
• Ensure understanding and facilitation of the risk based monitoring approach.
• Alert management to quality issues, requests QA audits as appropriate, and support direct reports and project team in providing audit responses as required.
• Manage and review systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
• Evaluate work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
• Manage staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approve courses of action on salary administration, hiring, corrective action, and terminations. Review and approve time records, expense reports, requests for leave, and overtime.

Education & Experience 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 0 to 5 years).
• 1+ year of leadership responsibility

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities:

• 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.
• 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), local requirements and any other subjects that impact clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.
• Participates in process improvement/development initiatives.
• Ensures understanding and facilitation of the risk based monitoring approach.
• Alerts management to quality issues, requests QA audits as appropriate, and supports direct reports and project team in providing audit responses as required.
• Manages and reviews systems (e.g. 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.
• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.

Why Join Us?

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 - where your contributions truly make a difference.