Manager Clinical Operations - TMF
Manager Clinical Operations - TMF
Posted on :
12-09-2025
Employer Active
1 Vacancy
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Job description:
- Develop a process framework by investigating analyzing and designing the integration of recurring milestone functionality into the TMF Oversight process
- Design a TMF Study Health Dashboard by investigating and analyzing current processes to effectively leverage the TMF Health Oversight process enabling improved visibility and proactive management of study health metrics
- Establish Inspection Readiness milestone tasks along with corresponding user enablement activities and comprehensive guiding documentation to ensure effective implementation and user adoption.
- Support the enhancement of the TMF Oversight knowledge management landscape by analyzing current guidance material and processes to enhance the organization accessibility and usability of critical information.
- Support the evolution of the existing TMF health analysis outcomes and metric set by refining current measures and identifying enhancements to drive improved oversight insights and decision-making.
- Investigate the utilization of system User Tasks within the TMF Oversight process to identify opportunities for optimization and alignment with oversight objectives ensuring enhanced efficiency and accountability.
Required Skills:
- Bachelors or Masters degree in related field preferably in medicine / science paramedical science computer science business management
- Sound knowledge across healthcare/pharmaceutical industry digital/IT industry incl. general understanding of pharma industry rules and regulations corresponding regulations and industry best practice (e.g. ICH-GCP FDA EMA ALCOA)
- Experienced in the pharmaceutical industry preferably in an international role with experience in Clinical Development/Operations with focus on Documentation Management and the management of the Trial Master File (TMF)
- Experienced in business/process consulting incl. change & stakeholder management
- Knowledge in implementation of processes and systems in the GCP area in a global setting
- Affinity for data and digitalization proven ability to utilize technologies to access information generate data-driven insights be creative innovative solve problems
- Effective communication and presentation skills
- Proficient in developing and maintaining process documentation
- Knowledge of relevant IT solutions and systems used in Clinical Documentation Management (Veeva Vault)
- Experience in managing and mitigating risks associated with clinical trial documentation.
- Fluent in English (both written and verbal)
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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