Trial Master File Manager

South San Francisco, CA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Trial Master File Manager in South San Francisco, CA.  The Trial Master File Manager will be 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.

RESPONSIBILITY

  • Manages the governance of the Trial Master File across PD, pRED, gRED and LMA
  • Alignment of the Client 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 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
  • As a member of the PMO, 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

EXPERIENCE

  • Minimum 10 years experience in a clinical development function
  • 5 years focused in TMF (must have at least some within the last year
  • Previous experience in clinical processes and systems development and maintenance preferred
  • 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 organizationProficient computer skills
  • Demonstrated integrity, courage and passion
  • Flexible attitude

EDUCATION

  • Bachelor's Degree

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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