[Remote] Associate Director, Data Review at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

Registered Nurse (RN), or equivalent clinical/medical background (e.g., PA) strongly preferred
Experience in clinical research, including experience as a Clinical Research Associate (CRA) or in a data oversight role
Strong understanding of data platforms, clinical trial processes, GCP, and regulatory requirements
Experience working with CROs and managing outsourced data review activities
Strong experience in reviewing EDC systems and clinical data listings
Excellent analytical, organizational, and communication skills
Ability to work independently in a fast-paced, startup environment

Responsibilities

Lead and manage clinical data review activities across assigned studies
Collaborate with internal colleagues, clinical trial sites, and external vendors / partners to support data cleaning, query resolution, and database lock processes
Review clinical data platforms, listings and reports to identify inconsistencies, trends, and potential issues and communicate and / or present findings, trends or analyses to relevant cross functional team as required
Review, from a medical and clinical aspect, data, anomalies and protocol deviations and communicate and / or present findings, trends or analyses to relevant cross functional team as required
Partner with cross functional teams including Clinical Operations, Clinical Development, PV, Data Sciences and Biostatistics to ensure data quality and compliance
Contribute to, and implement, data review plans and contribute to data management plans
Participate in vendor oversight, including performance monitoring and issue resolution
Support audit readiness and regulatory inspections by ensuring data traceability and documentation
Mentor junior team members and contribute to process improvement initiatives

Skills

Data Review

Clinical Trial Data

Query Resolution

Data Cleaning

Regulatory Submissions

Scientific Publications

CRA

Cross-functional Team Collaboration

Data Integrity

Data Completeness

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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