Trial Master File Specialist (Contract)

Location
Brisbane, CA
Posted
Jun 03, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

Manager: Sr. Manager, Clinical Oversight and Optimization
Department: Clinical Operations
Location: Remote

Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.

We are seeking top talent to join our mission. Let’s build a better future together.

JOB SUMMARY:   
Sangamo Therapeutics is seeking a contract Trial Master File Specialist who will facilitate the day-to-day management and oversight of Sangamo’s Veeva eTMF, participate in oversight/inspection readiness of CRO managed eTMFs, and support study teams with activities related to the maintenance and quality of TMFs.


ESSENTIAL FUNCTIONS: 

  • Oversight of Veeva eTMF administration inclusive of provisioning access, periodic access reviews, training new users, training all users on new features/configurations.
  • Acting as the Clinical department contact for Veeva eTMF system support (e.g., password resets, responding to questions).
  • Acting as the lead for Veeva eTMF change controls including periodic system releases and configuration changes and suggesting new configurations based on department needs.
  • Updating/creating training materials to align with new configurations and/or release features or to clarify use procedures.
  • Leading the update of necessary SOP revisions to align with new processes related to use of the Veeva eTMF system and/or new configurations.
  • Developing and making relevant updates to a template TMF plan for use with Veeva eTMF.
  • Assisting study teams with the development of study-specific Trial Master File Plans.
  • Performing Inspection Readiness QCs as needed or requested (either along with the assigned CTA or as 3rd party oversight)
  • As requested, providing or configuring reports out of Veeva eTMF to support study team oversight.
  • Liaising with and training Inspectors or auditors who are provisioned direct system access for inspections or audits.
  • Supporting the Clinical department with TMF related items that may include activities related to externally managed TMFs.


EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

  • Bachelor’s degree in a scientific discipline or RN
  • At least 2 years of clinical research experience
  • Prior experience with Veeva eTMF (experience with implementation and/or configuration of Veeva eTMF a plus)
  • Ability to multi-task and prioritize time to complete assigned work.
  • Self-motivated, high attention to detail, and able to function independently or as part of a team.
  • Effective communication and organizational skills


OTHER QUALIFICATIONS:

  • Requires little instruction on routine work and general instruction on new assignments.
  • Knowledge of pharmaceutical regulatory requirements
  • Knowledge of ICH GCP guidelines and clinical study regulations
  • Understands clinical study design and processes


Sangamo is an equal opportunity employer

The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.

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