Trial Master File Manager W2 ONLY 7527032 / 7333361 old

South San Francisco, CA

Post Date: 12/01/2017 Job ID: 3285 Industry: Professional Positions

7527032 Trial Master File Manager

W2 Only 12 Month Contract

LOCATION: South San Francisco, CA

 

Top Skills:

5 years of TMF experience (Trial Master Files), Drug Development / Clinical, ICH/GCP, gRED, and FDA

 

This position is in the PDG department, which deals with late stage clinical trials, and provides infrastructure to ensure trials are running smoothly and are completed on time, etc. 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 company and associated processes, including system and tool development, business process documentation and is ultimately responsible to ensure inspection readiness for the TMF across the company.

 

Duties:

 

Manage Trial Master File Manager operations (currently paper/electronic) across PD, pRED, gRED and LMA with a focus in the following key areas:

 
  • Oversee the backend work for TMF, communications, change management
  • 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 the assessment of performance
  • Coordinates the creation of domain specific processes
  • Enables the recruitment and training of TCS associates
  • Supports identification and implementation risk management plans
  • Supports the Domain specific steering committee operations
  • Develops an environment which fosters a high performance and innovative organization
  • Coaches staff in both functional and core competencies
  • Ensures specific focus on talent management, ensuring continuous development and mentoring of all talents
  • Ensures continuous training needs identified for succession and career development of staff
  • Serves as a mentor and role model
  • Collaborates with other business managers to leverage opportunities of job enrichment and development opportunities for staff

 

Skills:

 
  • Global experience with Trial Master File Manager and the regulations (FDA, DMA, etc)
  • Previous experience in clinical processes and systems development and maintenance preferred
  • Experienced enough to contribute to the several initiatives currently underway to make files more efficient
  • Capable of working with the Health Authority and answering any questions
  • Minimum 5 years of experience (recent) with TMF. If not recent experience, must be knowledgeable with current regulations
  • Must be comfortable with an ambiguous environment
  • Must be a self-starter. Someone who can assess a situation, propose a plan and then execute
  • Critical Thinking (Strategic)
  • 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.

 

Education:

 
  • A Bachelor' s degree and a minimum 10 years of experience in a clinical development function

Maurice Minnis


Not ready to apply?

Send an email reminder to:

Share This Job:

Related Jobs: