TMF Specialist

Job Title: TMF Specialist

 The TMF Specialist will support the Project Lead in all aspects of TMF development, tracking, and cleaning. In addition, this position will provide general administrative support to the Clinical Operations Department as needed.

Job Description:

• Perform aspects of the TMF process, with a high degree of accuracy and in accordance with GCP and SOPs, that include but are not limited to document upload, QC reviews, and document reconciliation.
• Support the Project Lead and Project Manager where necessary with vendor/document management, and internal document creation and maintenance.
• Work in tandem with the clinical team to develop a standardization of TMF design, documentation, QC, and approval of the TMF.
• Provide input and review of TMF Plans.
• Assist with organizing document reviews and issue management from internal, cross- functional and client monitoring reviews.
• May serve as a resource for and interact with other functional areas to resolve issues and facilitate trial timelines.
• May be assigned additional Clinical Operations tasks.
• Help create a fun, rewarding, and collaborative environment.

Requirements/Qualifications:

• High school diploma or equivalent; college degree preferred
• Knowledge and working experience with TMF Reference Model
• Knowledge in Veeva eTMF a plus
• 2-3 years of relevant clinical experience in a Pharmaceutical, Biotech or CRO environment preferred
• GCP and regulatory knowledge including FDA and ICH regulations
• A flexible attitude with respect to work assignments and continued industry related education
• Efficiently organizes workload of several simultaneous studies to ensure critical milestones are met, while also maintaining an expectation of quality work
• Must have ability to innovate, think strategically and conceptually, and manage multiple projects simultaneously
• Ability to handle difficult situations professionally and maintain a professional and caring demeanor
• Proven ability to collaborate in a team environment and work independently
• Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
• Must be responsible, creative and highly motivated
• Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills
• Ability to perform several tasks simultaneously to meet deadlines

Job Type: Full-Time; occasional weekend and evening hours

Location: San Diego, CA (Work Remotely due to COVID-19)

Work Remotely:

• Temporarily due to COVID-19
• This position will be based out of our San Diego, California office. Due to the COVID-19 pandemic, this position does not currently require regular in-office work (unless otherwise directed) until after Jan, 2022 at the earliest. Employee will primarily work with our internal Project Managers and Analysts. At present time, we have discouraged travel, however, as COVID-19 restrictions are lifted, some local travel may be required, with additional limited overnight travel.
• Travel
  • Must be able to travel by car/air to other CrO Biosciences meetings and events as needed.

COVID-19 Precaution(s):

• Remote interview process