Senior eTMF Specialist

SENIOR eTMF SPECIALIST

Summary:

The Senior eTMF Specialist in TMF Operations under the direction of Business Operations Managers and the Head of Business Operations and Analytics provides subject matter expertise and Clinical Operations Team support required to ensure that the Electronic Trial Master File (eTMF) is audit and inspection ready for ongoing GBT clinical trials.

Primary duties and responsibilities include, but are not limited to, the following:

• Provide oversight for eTMF user access review and routine TMF audits and follow-up activities
• Lead eTMF migration and change control activities
• Lead the development of eTMF-related document updates (SOPs, Guidelines, etc.) and oversee QC review and follow-up activities
• eTMF Lead for inspection-readiness activities, including identification of issues and corrective action plans
• Lead Veeva system updates in partnership with IT and/or vendors
• Lead TMF meetings and provide oversight of eTMF study team and vendor activities
• Lead training for study teams and/or vendors and provide oversight for onboarding new team members
• Support GBT eTMF-related initiatives
• Contribute to the specification, configuration, UAT and implementation of the eTMF Solution
• Provide status reports to senior management and project teams as needed
• Oversight of eTMF activities across clinical programs
• Manage issues and escalations in the TMF Program
• Review and assess CRO's eTMF SOPs to ensure GBT's minimum requirements are met
• Participate in audit and/or inspections of Clinical Operations and study specific eTMFs

Job Requirements:

• BA/BS degree or equivalent experience
• Minimum 7 years' experience in industry, with emphasis in eTMF
• Strong technical knowledge of eTMF solution software (i.e. Veeva Vault)
• Demonstrated current knowledge of ICH, GCP and other regulatory guidance as applicable to management of clinical documentation
• Detailed management of timelines, the ability to multitask, and adaptation to rapid change in the conduct of multiple, sometimes complex, clinical trials
• Demonstrated ability to assess current and future business needs to ensure the clinical documentation function is strategically and operationally positioned to properly support Clinical Operations, Regulatory Affairs, and Clinical QA
• Demonstrated leadership ability
• Experience leading and/or contributing to the selection and/or implementation of an electronic Trial Master File (eTMF)

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Ability to multitask across projects
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

#LI-DK1