Trial Master File Manager

South San Francisco, California | Contract

Post Date: 12/01/2017 Job ID: 3635 Industry: Medical Affairs

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They  are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Purpose:
  • The Trial Master File Manager is responsible for the archiving of all TMF related documents.
  • As such this person plans and coordinates the overall management of the Trial Master Files and associated processes, including system and tool development, business process documentation and is ultimately responsible to ensure inspection readiness for the TMF.

 

Manages the governance of the Trial Master File across PD, pRED, gRED and LMA with a focus in the following key areas:
  • Adherence to regulatory requirements and alignment of functional templates to individual functional documents
  • Development and maintenance of business processes
  • Input into supporting system and tool development
  • Input into TMF report development and business use
  • Coordination of TMF training  and support network
  • Ensure and coordinate proactive support for inspection readiness
  • Quality oversight across all Trial Master files
  • Responsible for the archiving of TMF' s
  • Contribute to the success of the group through regular correspondence and meetings
  • Manage KPIs and the assessment of performance
  • Coordinate the creation of domain-specific processes
  • Enable the recruitment and training of TCS associates
  • Support identification and implementation risk management plans
  • Support the Domain specific steering committee operations
  • Develop an environment which fosters a high-performance and innovative organization
  • Coaching of staff in both functional and core competencies
  • Ensure specific focus on talent management, ensuring continuous development and mentoring of all talents
  • Ensure continuous training needs identified for succession and career development of staff
  • Serve as a mentor and role model
  • Collaborate with other business managers to leverage opportunities of job enrichment and development opportunities for staff

Skills: 

  • A significant level of drug development expertise, specifically clinical trial management expertise
  • Good working knowledge of ICH/GCP, particularly in TMF Management
  • Demonstrated ability to think strategically across the drug development process and associated departments
  • Demonstrated ability to interact with all levels of customers and high proficiency in stakeholder management
  • Excellent communication skills at all levels of the organization
  • Proficient computer skills
  • Demonstrated integrity, courage and passion
  • Flexible attitude

 

Education:

  • A Bachelor's degree and a minimum 10 years experience in a clinical development function
  • Previous experience in clinical processes and systems development and maintenance preferred
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