Clinical Records Manager TMF Operations Remote with Travel

Profile

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development.  **MEMBERS ONLY**SIGN UP NOW***. is located in Emeryville, CA.

GENERAL SUMMARY:
The TMF Manager will manage the set-up, quality review, oversight documentation, compliance improvement, and archival of all study-specific Trial Master Files (TMFs) at 4DMT in accordance with 4DMT SOPs, industry best practice, and ICH/GCP Guidelines. The TMF Manager will support study teams to apply consistent process and quality standards across all TMFs to ensure audit readiness at all times.
RESPONSIBILITIES:

• Conduct trainings and/or kick-off meetings to educate internal and external staff and contributors about 4DMT Veeva Vault TMF business and systems procedures; Maintain training materials in alignment with current practice
• Perform the role of the Records Manager for all Clinical Trials at 4DMT throughout the TMF lifecycle, from study start up and document collection to oversight and archiving
• Responsible to develop, distribute, approve, and maintain study-specific TMF Plans and TMF Indexes
• Provide leadership in promoting TMF compliance, continuous improvement, and inspection readiness
• Participate in Quality Assurance audits and/or regulatory authority inspections
• Support Study Teams to proactively maintain current Expected Documents List (EDL) counts and to file essential documents in a timely manner according to TMF Plans and Indexes;  including adjustments due to unanticipated events during trial conduct
• Perform quality checks on individual documents as required by SOPs, TMF workflows, study-specific TMF plans, and TMF transfers/migrations; ensure quality issues are resolved and documents are approved in a timely manner
• Manage the schedule for Quality Oversight Reviews and ensure completion by their due dates; ensure TMF Compliance Milestones are adhered to during the entire study
• In collaboration with study-specific cross-functional teams, execute risk-based TMF oversight strategy and ensure standardized compliance criteria are applied across all studies
• Perform, or delegate and ensure, adequate documentation of periodic TMF Quality Reviews for inspection readiness in accordance with SOPs and the TMF Plan;
• Manage and provide study-specific quality oversight reports, metrics, KPIs to management
•  Identify study-specific TMF compliance gaps (missing or low quality documents) and track resolutions to closure quickly
• Manage the performance of external vendors responsible for TMF-related deliverables
• Escalate issues and/or process improvement suggestions and collaborate cross-functionally to define and implement solutions, Veeva Vault system changes, or corrective and preventative actions
• With the TMF Director, co-manage Sharepoint site for TMF User Information and other user support initiatives
• Contribute to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, tools
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS:

• Bachelor's degree

Experience:

• 7 years experience with Clinical Trial Operations
• Extensive experience with Veeva Vault TMF
• 3 years of TMF QC Review
• Clinical documentation content experience - Required
• Development and maintenance of TMF Plans
• Demonstrated understanding of the DIA Reference Model filing structure and contents
• Knowledge of and ability to apply applicable regulations and guidelines (ICH/GCP/Good Documentation Practice)
• Experience working with and managing cross-functional teams to improve TMF compliance (quality, completeness, and timeliness)

Preferred Experience:

• Creating and using enterprise system reports to calculate metrics and troubleshoot issues
• Managing CROs performing TMF activities
• All aspects of clinical trial conduct (startup through close-out)
• Experience with additional Veeva products such as CTMS or Vault RIM
• Experience using collaborative tools like Sharepoint and Microsoft Teams and Channels
• Gene therapy, rare/orphan disease, and/or early phase trials

Skills:

• Expert knowledge of cross-functional TMF content requirements throughout the trial
• Proficiency in Microsoft Office Suite for collaboration with team members
• Especially proficient in Excel for tracking, sorting, filtering, and managing large sets of metadata
• Excellent communication skills (written and verbal)
• Interpersonal skills, including conflict resolution in a fast-paced, deadline-driven environment
• Strong attention to detail and organizational skills
• Ability and drive to follow through on detailed tasks to closure
• Analytical skills to evaluate and interpret complex situations/problems using multiple sources of information

Physical Requirements:

• Adhere to 4DMT COVID protocols and policy, including proof of current vaccination status to work on-site
• May require to travel up to 10% on-site, but the role is fully remote until deemed safe to travel to the Emeryville office

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

About 4DMT:
**MEMBERS ONLY**SIGN UP NOW***., Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused on three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated, and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity, and, where relevant, having resistance to pre-existing antibodies.

Attention: Search Firms / 3rd Party Recruitment Agencies*
The Talent Acquisition / HR team manages the recruiting for all positions at **MEMBERS ONLY**SIGN UP NOW***.. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to **MEMBERS ONLY**SIGN UP NOW***. will be considered property of **MEMBERS ONLY**SIGN UP NOW***.. **MEMBERS ONLY**SIGN UP NOW***. will not be responsible for any fees associated should we hire from unsolicited resumes.

Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions. Recruiters interested in working with **MEMBERS ONLY**SIGN UP NOW***. can submit their information to ****– should we have a tough-to-fill role, we will ****T04:19:55 00:00,validThrough:2022-04-02T03:59:59 00:00,employmentType:FULL_TIME,hiringOrganization:{name:**MEMBERS ONLY**SIGN UP NOW***.,@id:399574,url:****CA,address:{addressCountry:US,addressLocality:California,addressRegion:California,postalCode:94608,@type:PostalAddress},@type:place},industry:Clinical, Clinical Research, Manufacturing & Production,workHours:Full time,educationRequirements:Bachelors Degree,@type:JobPosting,@context:****

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