Associate Manager/Manager Clinical Operations/Sr Manager Clinical Operations

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Discover Impactful Work:

Oversees daily line management responsibilities of assigned team. Serves as positive leadership and professional role model for respective staff. Provides direct coaching and development support to operational teams. Ultimately responsible for effective resourcing, alignment, training and on-going professional and technical development for staff. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Primary focus on line and performance management of team members assigned to any monitoring modality and/or environment. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.

A Day in the Life:

• 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) and Standard Operating Procedures (SOPs), 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.

Keys to Success:

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.

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.

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 upto-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) and Standard Operating Procedures (SOPs), 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.

Work Environment:

Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
• This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Compensation and Benefits
The salary range estimated for this position based in North Carolina is $95,000.00-$159,100.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards