Job Description

Work Schedule


Standard (Mon-Fri) Environmental Conditions


Office


At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Location/Division Specific Information
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Our Project Delivery colleagues within PPD clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials.


Through our diverse team, our members engage in variety of initiatives and projects, or are part of global project teams gaining cross-cultural experience. Therapeutic scope includes: Hematology/Oncology, Vaccines, Infectious and Respiratory Diseases, General Medicine, Neurosciences and Cardiovascular/Metabolic.

Discover Impactful Work:
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The Clinical Team Manager (CTM) combines deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. The CTM takes ownership of clinical deliverables, anticipates problems, finds solutions and delivers results.

A day in the Life of a CTM:
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• Manages all clinical operational and quality aspects of allocated studies, involving moderate to high complexity, in compliance with ICH-GCP. In accordance with project specific requirements, may assume Lead CTM responsibilities on a global or regional level, or take additional tasks such as process improvements, management of complex programs, or project coordination.
• Develops monitoring strategy (e.g. remote, onsite and/or centralized approach) and clinical tools (e.g. Monitoring Plan, Recruitment Plan templates) in alignment with the study protocol and contract/scope of work with the client.
• Collaborates with the Project Lead for the development of the Project Plan and to prepare or present at client meetings, including bid defense and kick-off meetings.
• Manages project financials for all clinical activities, identifies OOS tasks and supports creation of Contract Modifications with the Project Lead.
• Oversight of the clinical team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained.
• Ensures achievement of the final clinical deliverables within the contractual time specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the Project Lead, by regularly reviewing, tracking and use of management tools, implementing risk management plan, and managing CRF review and verification.
• Collaborates with the start-up team on conducting site feasibility and selection, and ensuring sites are activated based on the study timelines.
• Responsible for the implementation and training of project specific processes and according to corporate standard policies.

Education
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• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience
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• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
• Experience in the following therapeutic area: Hematology/Oncology, Vaccines, Infectious and Respiratory Diseases, General Medicine, Neurosciences and Cardiovascular/Metabolic.

Knowledge, Skills, Abilities
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• Effective leadership, mentoring and training skills; capable of motivating and integrating teams
• Excellent planning and organizational skills to ensure effective prioritization of workload and workload of team members
• Solid 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, critical thinking, and risk management skills
• Effective oral and written communication skills, including English language proficiency
• Provides excellent customer service and fosters collaboration among internal and external stakeholders
• Capable of evaluating own and team members workload against project budget and adjusting resources accordingly
• Sound financial knowledge of budgeting, forecasting and fiscal management i.e managing clinical activities within budget or identifying out of scope activities and raising these accordingly
• Thorough attention to detail
• In-depth understanding of relevant regulations e.g. ICH-GCP, FDA guidelines, EuCTR regulations, etc.
• Robust computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, Teams, PowerPoint, etc.
• Capable of independently managing clinical only studies, based on experience level

Work Environment
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Thermo Fisher Scientific values the health and wellbeing 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 20%, inclusive of traveling in automobiles, airplanes, and trains.
• Employees hired in this role may be assigned to a US government contract and if so would be subject to COVID-19 vaccination and reporting requirements.