Clinical Trial Manager
hace 7 meses
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**:
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 include: General Medicine.
**Discover Impactful Work**:
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**:
- 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**:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
**Experience**:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- Experience in the following therapeutic area: General Medicine - Dermatology, GI, (UC/CD), Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia).
**Knowledge, Skills, Abilities**:
- 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.
- Capable of independently managing clinical only
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