Manager Clinical Operations - TMF
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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
Key Skills
- Six Sigma
- Lean
- Management Experience
- Process Improvement
- Microsoft Outlook
- Analysis Skills
- Warehouse Management System
- Operations Management
- Kaizen
- Leadership Experience
- Supervising Experience
- Retail Management
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
