Senior Clinical Trial Manager
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Taiwan
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Job Level
Tech Stack
About the role
- Manage all clinical operational and quality aspects of allocated studies, of moderate to high 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 (local and central).
- Collaborate with the project manager to prepare, organize, and present at client meetings.
- Regularly communicate with the team and leads team meetings to ensure timelines, resources, interactions, and quality are maintained.
- Ensure achievement of the final clinical deliverable within the contractual time period.
- Communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- 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 8+ years).
- Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
- Strong planning and organizational skills to enable effective prioritization of workload and workload of team members.
- Strong 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, and risk management skills.
- Effective oral and written communication skills, including English language proficiency.
- Capable of evaluating own and team members workload against project budget and adjust resources accordingly.
- Strong financial acumen and knowledge of budgeting, forecasting and fiscal management.
- Strong attention to detail.
- In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
- Capable of independently managing clinical only studies.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical operational managementquality managementclinical monitoringresource managementbudgetingforecastingrisk managementchange managementdata quality planningtrial master file management
Soft skills
leadershipmentoringteam integrationplanningorganizational skillsinterpersonal skillsproblem solvingcommunicationattention to detaildecision making