Sr. Manager - Clinical Documentation

About Genetix Biotherapeutics

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

SUMMARY

The eTMF Senior Manager Oversees the eTMF (electronic Trial Master File) creation, maintenance, and archiving, ensuring each are performed in accordance with Standard Operating Procedures (SOP), ICH-GCP Guidelines, EMA, FDA, and other appropriate regulations. As the eTMF Senior Manager, the individual will contribute to the integrity, completeness, and accuracy of Genetix Biotherapeutics’ eTMF. The eTMF Senior Manager will continuously work in a team environment including meeting deadlines, liaising with contractors, balancing work, and projects from multiple sources. The eTMF Senior Manager  will collaborate with Associate Director and Director on projects as needed.

RESPONSIBILITIES

• Ensure end users have access to system and process information. This may include managing the eTMF SharePoint page, conducting eTMF office hours, or initiating an eTMF newsletter.
• Serve as primary eTMF contact for pivotal studies, ensuring questions related to eTMF items are addressed in a timely manner.
• Applies knowledge of ICH-GCP, FDA, and EMA regulations when reviewing documentation to identify if a Quality Issue is warranted and/or needs to be created in the eTMF system for further follow-up.
• Applies knowledge of ICH-GCP, FDA, and EMA regulations when providing guidance or answering questions to study team to ensure adherence to document standards.
• Applies knowledge of the DIA TMF reference model to assist Functional Leads to revise and update study specific Master List templates and Naming Conventions
• Subject Matter Expert for assigned studies, responsible for creating tools, such as monthly dashboards to be presented to stakeholders during team meetings. This involves analysis of key metrics and key performance indicators (KPIs) for completeness, quality, and timeliness.
• Collaborate with Associate Director on annual system Naming Convention updates to ensure documents are correctly uploaded into the eTMF system.
• Leads eTMF kick-off meeting for new studies, ensuring roles are assigned as per eTMF SOP. Drives the creation of eTMF Plans, and Study-specific Master Lists.
• Conducts frequent review of system and process to identify improvements. Includes ability to take information from lessons learned or eTMF community experience.
• Acts as a back-up Subject Matter Expert (SME) for eTMF system and process.
• Primary contact for end-users regarding system issues. Escalate to Associate Director and/or Veeva Help Desk as appropriate.
• Acts as inspection TMF SME for the assigned studies and starts preparing for the Inspection Readiness activities for the studies, which includes the following: Conducting TMF gap analysis activities, updating BIMO checklists, supporting mock inspections.
• During Inspection, readiness activities collaborate with consultants’ and study’s PM to create placeholders; and liaise with study’s PM to identify missing documents and identify remediation strategy to obtain missing documents.
• Attend inspection readiness meetings and provide TMF related updates to team members.
• Act as a part of core inspection team and as a backup for other studies to own the key responsibilities such as document requests, access to the TMF for the auditors and inspectors, ensuring easy retrieval of documents on request and help other subject matter experts (SMEs) as per the inspection plan.

QUALIFICATIONS

• Minimum bachelor’s degree required in a biomedical, life science, or related field of study.
• Minimum of 7 years’ industry experience in supporting the operations of clinical studies, including duties related to records management and maintenance of TMF/eTMF.
• In-depth knowledge of ICH-GCP, FDA, and EMA regulations.
• In-depth knowledge of the DIA TMF reference model.
• Previous project management experience preferred.
• Ability to manage competing priorities.
• Excellent organizational skills, able to multi-task in an extremely fast-paced environment.
• Thrives in a dynamic environment.
• Positive, outgoing and collaborative attitude.

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.