Trial Master File Manager W2 ONLY 7333361

South San Francisco, CA

Post Date: 08/28/2017 Job ID: 3121 Industry: Professional Positions

W2 ONLY    12 Month Contract

 

Position 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 for our client and associated processes, including system and tool development, business process documentation and is ultimately responsible to ensure inspection readiness for the TMF.

 

Major Responsibilities:

Manages  the governance of the Trial Master File across PD,  pRED, gRED and LMA with a focus in the following key areas:
  • Alignment of our client' s Reference Model (RRM), including adherence to regulatory requirements and alignment of functional templates to individual functional documents
  • Development and maintenance of business processes
  • Input into supporting systems 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 
  • As a member of the PMO, contribute to the success of the group through regular correspondence and meetings

 

The TMF Manager provides the key link between our client' s functional department and TATA Consultancy Services with a focus in the following key area:
  • Manages KPI' s and he 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

 

Qualifications:
  • 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

 

 

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
  • Developing yourself Collaboration & Teamwork
  • Decision Making / Change Management Skills
  • Driving for Results / Efficiency
  • Analytical Expertise

 

*Ability to travel internationally up to 15% and work across different geographically located sites.

Calley Molina


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