CTM/Sr CTM - FSP - EMEA
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Key skills for this role
About the Role
Thermo Fisher Scientific seeks a Clinical Trial Manager to oversee clinical operational and quality aspects of studies in EMEA. The role requires managing clinical deliverables, developing clinical tools, and ensuring compliance with ICH GCP.
Key Skills for This Role
Responsibilities
- Manage all clinical operational and quality aspects of allocated studies of low to moderate complexity in compliance with ICH GCP
- Develop clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan
- Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File
- Collaborate with the clinical team and other departments to meet project deliverables
- Regularly communicate with the team and lead team meetings to maintain timelines, resources, interactions, and quality
- Ensure achievement of the final clinical deliverable within the contractual time period by preparing and monitoring clinical activity timelines and metrics
- Continuously monitor or co monitor clinical trials to assess performance and ensure contractual obligations are met
- May communicate with study sites regarding protocol, patient participation, case report form completion and other study related issues
- May coordinate all start up activities and ensure timely ethics committee and regulatory submissions
- May provide input into preparation of forecast estimates for clinical activities
Requirements
- Bachelor's degree or equivalent relevant formal academic/vocational qualification
- Previous experience comparable to 5+ years providing knowledge, skills, and abilities to perform the job
- Good leadership skills, effective at mentoring and training
- Good planning and organizational skills
- Solid interpersonal and problem solving skills
- Familiarity with clinical monitoring practices, processes, and requirements
- Effective oral and written communication skills, including English language proficiency
- Solid understanding of relevant regulations e.g., ICH/GCP, FDA guidelines
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word
Full Job Posting
Job Description
- The Clinical Trial Manager is accountable for achieving the final clinical deliverable within the time period specified in the contract with the customer.
- The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
What You'll Do
- Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP.
- Develop clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
- Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File.
- Collaborate with the clinical team and other departments as needed to meet deliverables of the project.
- Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained.
- Ensure achievement of the final clinical deliverable within the contractual time period by preparing and monitoring clinical activity timelines and metrics.
- Continuously monitor or co monitors clinical trials to assess performance and ensure contractual obligations are met.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study related issues.
- May coordinate all start up activities and ensures that timely ethics committee and regulatory submissions are addressed.
- May provide input into preparation of forecast estimates for clinical activities.
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 5+ years).
Knowledge, Skills, Abilities
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acumen and knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
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.
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