Thermo Fisher Scientific

Manager, Clinical Operations – TMF

Thermo Fisher Scientific

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇮🇳 India

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud PlatformVault

About the role

  • 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.

Requirements

  • 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)
Benefits
  • Reasonable accommodation for individuals with disabilities
  • Equal Opportunity Employer

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
process framework developmentTMF Oversightdata-driven insightsdocumentation managementclinical developmentchange managementstakeholder managementrisk managementsystem optimizationuser enablement
Soft skills
effective communicationpresentation skillsproblem-solvingcreativityinnovation