Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office

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)

Skills Required