- Responsible for TMF Oversight development and execution, ensuring all clinical documentation is being collected, handled, transferred, and stored via secured and authorized methods, ensuring compliance with global and local standards, requirements, and guidelines.
- Manage TMF performance objectives for end-to-end processes ensuring quality, timeliness, and completeness throughout the lifecycle of the study by overseeing and/or ensuring ongoing reviews to confirm documents are collected and maintained per ICH guidelines and global regulatory requirements.
- Perform the role of the Clinical Records Associate for all Clinical Trials at 4DMT throughout the TMF lifecycle, from study start-up and document collection to oversight and archiving.
- 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 promptly according to TMF Plans and Indexes, including adjustments due to unanticipated events during trial conduct.
- 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.
- 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:Education:
- Applicants are expected to have either a bachelor's degree (preferably in a scientific or healthcare-related field) or, in the absence of a formal degree, a minimum of four years of relevant training and work experience in document control.
Experience: - 2 years relevant experience including extensive experience with Veeva Vault TMF.
- 2+ years of TMF QC Review and knowledge of clinical documentation content 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 (e.g., ICH/GCP/Good Documentation Practice).
- Experience working with cross-functional teams to improve TMF compliance (quality, completeness, and timeliness).
Required 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.
Preferred Skills: - Managing CROs performing TMF activities.
- Creating and using enterprise system reports to calculate metrics and troubleshoot issues.
- All aspects of clinical trial conduct (startup through close-out and TMF Archiving).
- Experience with additional Veeva products such as CTMS or Vault RIM.
- Experience using collaborative tools like SharePoint and Microsoft Teams and Channels.
Base salary compensation range:
$85,000/yr - $107,000/yr
Bay Area Range:
$95,000/yr - $124,000/yr
Please note that compensation varies on a variety of factors including location, experience, etc.
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 -
Clinical Records Associate, TMF Operations
1 week ago
4D Molecular Therapeutics Emeryville, United StatesWe are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative enviro ...
-
Clinical Records Associate, TMF Operations
1 week ago
4D Molecular Therapeutics Emeryville, United StatesWe are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative enviro ...
-
BridgeBio Pharma San Francisco, CA, United StatesEidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of ...
-
Clinical Trial Manager Associate
1 week ago
Vera Therapeutics Brisbane, United States**Title: Clinical Trial Manager Associate** · **Location**:Brisbane, CA** · **About Us**: · Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ...
-
Sr. Clinical Trial Associate
3 weeks ago
4D Molecular Therapeutics Inc. Emeryville, United StatesGENERAL SUMMARY: · 4DMT seeks a motivated and experienced Senior Clinical Trial Associate to support the Company's clinical trial activities. This position reports to the CTM/Sr. CTM, Clinical Operations and will be responsible for supporting the day-to-day operations of one or m ...
-
Clinical Trial Manager
3 weeks ago
Dynavax Emeryville, United StatesThis position can be 100% remote. · Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. We operate with the highest level of quality, integrity and safety for the betterment o ...
-
Clinical Research Associate Ii
3 weeks ago
Abbott Laboratories Alameda, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
Sr. Clinical Trial Associate
1 week ago
BioSpace Emeryville, United StatesJob Details · Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching ou ...
-
Clinical Trial Manager
3 weeks ago
Dynavax Technologies Emeryville, United StatesThis position can be 100% remote. · Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. We operate with the highest level of quality, integrity and safety for the betterment ...
-
Sr. Clinical Trial Manager
1 week ago
4D Molecular Therapeutics Inc. Emeryville, United StatesGENERAL SUMMARY: · * This is a 6 month contract role* · 4DMT is recruiting for a motivated and experienced Sr. Clinical Trial Manager to support the Company's clinical trial activities. This position reports to the Associate Director/ Director of Clinical Operations. This role wi ...
-
Manager, CGP Compliance
3 weeks ago
BeiGene Emeryville, United States**General Description:** · This position will report directly to the Director, GCP Compliance within the Clinical Operations Americas group. This individual will be integral to GCP inspection readiness efforts at BeiGene and will serve as a GCP compliance expert to the organizat ...
-
Sr. Clinical Trial Manager
1 week ago
4D Molecular Therapeutics Inc. Emeryville, United StatesGENERAL SUMMARY: · 4DMT is recruiting for a motivated and experienced Sr. Clinical Trial Manager to support the Company's clinical trial activities. This position reports to the Associate Director/ Director of Clinical Operations. This role will be within the ophthalmology progra ...
-
Global Clinical Study Senior Manager
1 week ago
BeiGene Emeryville, United States**General Description:** · + Accountable for global study delivery with appropriate inspection readiness quality, within agreed timelines and budget · + Leads all aspects of assigned clinical study(ies) · + Leads global cross-functional study team (including oversight of external ...
-
Sr. Clinical Trial Associate
2 weeks ago
4D Molecular Therapeutics Emeryville, United StatesAttention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to h ...
-
Sr. Clinical Trial Associate
2 weeks ago
4D Molecular Therapeutics Emeryville, United StatesAttention recruitment agencies: · All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly t ...
-
Sr. Clinical Trail Manager
3 weeks ago
BioSpace Emeryville, United StatesJob Details · Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching ou ...
-
Sr. Clinical Trial Manager
1 week ago
BioSpace Emeryville, United StatesJob Details · Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching ou ...
-
Sr. Clinical Trial Manager
1 week ago
BioSpace Emeryville, United StatesJob Details · Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching ou ...
-
Regional Clinical Study Senior Manager
1 week ago
BeiGene Emeryville, United States**Position Summary:** · + Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget · + Acts as regional lead for multiple studies across an indication or across a program as required · + Leads the regional clinical ...
-
Sr. Clinical Trial Manager
1 week ago
4D Molecular Therapeutics Emeryville, United StatesGENERAL SUMMARY: · 4DMT is recruiting for a motivated and experienced Sr. Clinical Trial Manager to support the Company's clinical trial activities. This position reports to the Associate Director/ Director of Clinical Operations. This role will be within the ophthalmology progra ...
Clinical Records Associate, TMF Operations - Emeryville, United States - 4D Molecular Therapeutics
Description
Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future. 4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases. We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency. To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases. In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT. Company Differentiators: GENERAL SUMMARY: We are seeking a Clinical Records Associate for our TMF Operations Department Reporting to the Associate Director of TMF Operations. This position is responsible for collecting, reviewing, maintaining, and archiving essential documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and 4DMT's Standard Operating Procedures (SOPs) as appropriate. RESPONSIBILITIES:
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
