Abata Therapeutics

Manager of Clinical Data Management

Remote

Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries

Requirements

The Manager of Clinical Data Management should have experience in supporting clinical trial portfolios and a strong understanding of data management processes from database start-up through lock and submission. A proven ability to manage CRO activities, develop study timelines, and oversee the creation of key data management documents like CRFs and DMPs is necessary. Experience with EDC systems, ePRO/eCOA, and IVRS, as well as familiarity with regulatory authority regulations and SOPs, are required.

Responsibilities

The Manager of Clinical Data Management will oversee all data management CRO activities, serving as the primary point of contact for CROs, vendors, and internal teams. Responsibilities include developing study timelines, ensuring timely delivery of data management deliverables, and overseeing the development and validation of clinical databases and related documents. The role involves managing data cleaning activities, reconciling external databases, reviewing study budgets and SOWs, and ensuring the quality of clinical data within EDC and external sources. Additionally, the manager will participate in the review of clinical research documents and maintain internal data review logs to resolve issues.

Skills

Clinical Data Management
Clinical Trials
Database Lock
Regulatory Compliance
SOPs
Working Practices

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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