Clinical Trial Manager – Observational Studies
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Brazil
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Job Level
Tech Stack
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.
- Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File.
- Collaborate with the project manager to prepare, organize, and present at client meetings.
- 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.
- Ensure achievement of the final clinical deliverable within the contractual time period specified.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion.
- May coordinate all start-up activities and ensures timely ethics committee and regulatory submissions are addressed.
- Responsible for clinical resource management, assignment, and delegation of responsibilities.
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, 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.
- 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
- Health insurance
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical operational managementquality assuranceclinical monitoring processesresource managementbudgetingforecastingfiscal managementdata quality plan developmentTrial Master File managementprotocol compliance
Soft Skills
leadershipmentoringteam integrationplanningorganizational skillsinterpersonal skillsproblem-solvingjudgmentdecision-makingattention to detail
Certifications
Bachelor's degreeICH GCP certification