Manager Clinical Operations - TMF

Thermo Fisher Scientific; Jashpur; On-site; INR 9,50,000 - 12,00,000; Full time

Job summary

A global scientific services company is seeking a qualified professional to enhance TMF Oversight processes in Jashpur, India. Key responsibilities include developing process frameworks and dashboards to improve study health visibility, along with managing documentation in compliance with industry regulations. The ideal candidate holds a degree in a relevant field and has experience in the pharmaceutical industry, particularly in Clinical Development and TMF management. Fluency in English and strong analytical skills are essential.

Qualifications

• Bachelor's or Master's degree in a relevant discipline like medicine or computer science.
• Experience in Clinical Development/Operations with a focus on TMF management.
• Knowledge of regulations and industry best practices.

Responsibilities

• Develop process frameworks for TMF Oversight.
• Design a TMF Study Health Dashboard for monitoring metrics.
• Support TMF Oversight knowledge management enhancements.

Skills

Healthcare knowledge

Documentation Management

Change management

Data analysis

Communication skills

IT solutions knowledge

Problem-solving

Education

Bachelor's or Master's degree in a related field

Tools

Veeva Vault

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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

• Bachelor´s or Master´s 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)