TMF Specialist at Abata Therapeutics

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

Minimum of 2 years of experience managing TMF activities to support clinical studies
Experience managing multiple TMFs in paper, electronic, and hybrid format, with process consistency, quality, and in compliance with regulatory requirements
Deep understanding of clinical trial documents and industry standard TMF Reference Model and requirements for processing documentation into the eTMF system
Strong working knowledge of the drug development process, Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations
Working knowledge of international regulatory and ethics record requirements
Working knowledge of relevant global privacy regulations
Experience with TMF archiving and global records retention requirements for clinical trials, including preparing a TMF for archival, executing final quality checks, working with internal and external stakeholders to resolve findings

Responsibilities

Set up study eTMF in accordance with study requirements
Support document filing in MapLight’s internal eTMF
Support TMF Quality in accordance with MapLight SOPs and regulatory requirements (ICH GCP)
Create study-specific TMF Plans and Maps to align with system usage and TMF quality requirements in collaboration with CROs and vendors
Liaise with core study team members to secure alignment on study specific TMF processes
Perform roles and responsibilities for filing and document QC
Perform TMF quality checks and completeness/content reviews
Perform routine QC of the study TMFs as outlined in study TMF Plans and escalate risks and/or issues related to TMF quality to the study team
Ensure overall TMF completeness with MapLight’s functional groups, CROs, and vendors
Monitor TMF metrics for compliance (e.g., document processing times)
Escalate TMF quality issues and drive resolution of required CAPAs and/or process improvement, as applicable
Review documents submitted to eTMF for suitability and quality
Generate and oversee resolution of TMF findings related to QC, completeness reviews, audits, and inspections
Act as eTMF SME at study Kick-off meeting and Investigator meetings (CRA training) and attend regular study team meetings to report on the status of the TMF
Support the study teams to ensure study TMFs are submission and inspection ready at all times
Support TMF Archival Activities, as assigned (including pre-archival QC for CRO managed TMFs transferred to MapLight, completing archival documentation, and archiving TMFs in MapLight’s eTMF)
Support study teams in archiving the TMFs
Other such duties as requested or assigned
Embody and demonstrate MapLight’s core values of Integrity, Collaboration, Bravery, and Dedication

Skills

eTMF

TMF Management

ICH GCP

Quality Control

SOP Compliance

Document QC

Trial Master File

CRO Collaboration

Inspection Readiness

Regulatory Compliance

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters

2021Year Founded

$184.8MTotal Funding

EARLY_VCCompany Stage

BiotechnologyIndustries

11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.

Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.

Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.

Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.

Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.

FDA's accelerated approval pathways may expedite Abata's clinical trials.

Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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