Clinical Data Manager at Abata Therapeutics

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in life sciences, computer science, or a related field. Advanced degree preferred
Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry
Proficiency in Medidata Rave electronic data capture (EDC) system
Strong understanding of Good Clinical Practice (GCP) guidelines, regulatory requirements (e.g., FDA, EMA), and industry standards (e.g., CDISC)
Excellent communication, organizational, and problem-solving skills
Ability to work effectively in a fast-paced, cross-functional team environment
Attention to detail and commitment to data quality and integrity

Responsibilities

Manage and lead all aspects of clinical trial data management activities from study start-up to database lock
Develop and implement data management plans, data validation plans, edit check plans and data entry guidelines in compliance with regulatory standards and company SOPs
Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs to ensure data quality and integrity throughout the trial lifecycle
Oversee Medidata Rave electronic data capture (EDC) system setup, configuration, user management, coding and data extracts
Perform data cleaning, discrepancy management, SAE and vendor integration reconciliation activities to ensure timely database lock
Conduct periodic data reviews and generate weekly data quality metrics to identify trends and outliers
Identify Protocol Deviations
Produce medical monitor, coding listings and ad hoc listings for team review (Jreview, SAS, Business Objects)
Participate in the development and review of clinical study protocols, case report forms (CRFs), and clinical trial documentation
Provide support for regulatory submissions, audits, and inspections related to clinical trial data management
Stay current with industry standards, best practices, and regulatory requirements related to clinical data management

Skills

Medidata Rave

EDC

SAS

JReview

Business Objects

Data Validation

Edit Checks

Data Cleaning

SAE Reconciliation

CRF Design

Protocol Deviations

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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