Thermo Fisher Scientific

Senior/Principal Clinical Team Manager – Neuroscience

Thermo Fisher Scientific

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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.
  • 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).
  • Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
  • 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.
  • Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies.
  • Responsible for the timely archiving of documents and study materials for the department.
  • Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics.
  • Provide status updates to the project manager, regularly reviewing projects using tracking and management tools.
  • 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 (if appropriate) are addressed.
  • Ensure that essential document quality meets the expectation of Regulatory Compliance Review.
  • May provide input into preparation of forecast estimates for clinical activities.
  • Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

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)
  • Good leadership skills, effective at mentoring and training
  • 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
  • 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.
Benefits
  • Collaborative and development-oriented environment
  • Opportunities to make a significant impact in the clinical trial process
  • Professional growth and advancement opportunities
  • Access to cutting-edge research and methodologies
  • Supportive work culture focusing on innovation and excellence
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical monitoringproject managementresource managementbudgetingforecastingregulatory compliancequality assurancedata quality planningclinical trial performance assessmentdocument archiving
Soft Skills
leadershipmentoringplanningorganizational skillsinterpersonal skillsproblem solvingjudgmentdecision makingattention to detailcommunication
Certifications
Bachelor's degreeICH GCP certificationFDA guidelines knowledge