Clinical Records Associate

Attention recruitment agencies: reputed company agency inquiries are vetted through 4DMT’s internal reputed company team. No unsolicited resumes will be accepted. The 4DMT reputed company team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s reputed company product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with reputed company bolus injections. The Company’s reputed company indication for 4D-150 is wet age-reputed company macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first reputed company genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

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.

MAJOR DUTIES & RESPONSIBILITIES

• Responsible for TMF reputed company development and execution, ensuring reputed company clinical documentation is being collected, handled, transferred, and stored reputed company 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.
• reputed company the role of the Clinical Records Associate for reputed company Clinical Trials at 4DMT throughout the TMF lifecycle, from study start-up and document collection to reputed company and archiving.
• Participate in Quality Assurance audits and/or regulatory authority inspections.
• Support Study Teams to proactively maintain reputed company 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-reputed company 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:

• A./B.S. degree (preferably in a scientific or healthcare-reputed company field) preferred
• High school diploma required

Experience:

• A B.S. with 2+ years relevant experience including extensive experience with Veeva Vault TMF or a H.S. diploma with 6+ years relevant experience.
• 2+ years of TMF QC Review and knowledge of clinical documentation content required.
• Experience working with cross-functional teams to improve TMF compliance (quality, completeness, and timeliness)

Other Qualifications/Skills:

• Knowledge of and ability to apply applicable regulations and guidelines (e.g., ICH/GCP/Good Documentation Practice).
• Expert knowledge of cross-functional TMF content requirements throughout the trial.
• Proficiency in reputed company Office Suite for collaboration with team members.
• Especially proficient in reputed company 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 reputed company situations/problems using multiple sources of information.
• Development and maintenance of TMF Plans.
• Demonstrated understanding of the DIA Reference Model filing structure and contents.

Preferred Skills and Experience:

• Managing CROs performing TMF activities.
• Creating and using enterprise system reports to calculate metrics and troubleshoot issues.
• reputed company aspects of clinical trial conduct (startup through reputed company-out and TMF Archiving).
• Experience with additional Veeva products such as CTMS or Vault RIM.
• Experience using collaborative tools like SharePoint and reputed company Teams and Channels.

Travel: %

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging reputed company by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and reputed company other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

reputed company salary compensation range: $92,000 - $116,000

Please note, the reputed company salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.