Senior CTM - Non Interventional Studies/Phase IV Studies

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Join Us as a Senior Clinical Team Manager - Make an Impact at the Forefront of Innovation

The Senior Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. The role involves working to ensure that all clinical deliverables meet the customer's time/quality/cost expectations, and maintaining profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically the Senior Clinical Trial Manager works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.

We are looking for experienced Sr CTMs with previous experience in the role and preferably experience in the Start Up Team Manager role. Previous experience in non-interventional / Phase IV studies is also preferable

What You'll Do:

• Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities, e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.
• Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.

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 8+ years).
  
  

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:

• Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
• Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
• Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization
• Solid understanding of change management principles
• Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
• Strong judgment, decision making, escalation, and risk management skills
• Effective oral and written communication skills, including English language proficiency
• Capable of evaluating own and team members workload against project budget and adjust resources accordingly
• Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
• Strong attention to detail
• In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
• Capable of independently managing clinical only studies.
  
  

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—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

Unfortunately, we cannot consider CRAs at this time due to current business needs.