Clinical Trial 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, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Experience in clinical trial management, particularly in neurological and psychiatric pipelines
Knowledge of FDA, EMA, ICH GCP guidelines, and SOPs
Ability to manage cross-functional study teams, external vendors (e.g., CROs, central labs, IRBs/ECs), and stakeholders
Skills in study budgeting, site contracting, vendor performance tracking, and invoice review
Capability to anticipate, recognize, and manage issues/risks, including analysis and corrective actions
Experience in quality-by-design efforts and inspection readiness
Familiarity with study management tools, metrics tracking, and reporting

Responsibilities

Manage all aspects of study progress from protocol development and planning to study close-out, including supporting clinical study reports, ensuring adherence to timelines, goals, quality, FDA, EMA, ICH GCP guidelines, and MapLight SOPs
Collaboratively manage cross-functional study team activities and communicate with/manage external vendors and stakeholders (e.g., CROs, central labs, IRBs/ECs)
Participate in evaluation, selection, and oversight of CROs and other external vendors
Communicate with clinical trial sites to ensure optimal Sponsor-Site relationships
Communicate trial status within and outside the study team to align expectations, priorities, and deliverables (e.g., subject enrollment, monitoring, site compliance, data metrics)
Lead clinical study budgeting and site contracting process with the legal team
Provide input to study-level budgets and manage assigned budgets by tracking vendor performance against scopes of work, contracts, invoices; facilitate review of scopes, invoices, change requests, and orders
Anticipate, recognize, and manage issues/risks; inform Senior Management as needed
Analyze clinical study and site risks and implement corrective actions
Drive quality-by-design to identify/manage risks and ensure inspection readiness
Lead development and execution of operational activities in study plans, SOPs, procedures
Coordinate development, review, and distribution of critical study documents (e.g., ICFs, operational plans, protocols, study reports, newsletters)
Assist Global Supply Chain team with oversight of study drug supply, projections, distribution, labeling, and destruction
Track clinical study metrics and report to management
Plan, facilitate, and monitor training at investigator meetings, kick-off meetings, and CRO/vendor meetings
Perform quality assurance checks (e.g., protocol reviews, monitoring trip reports, co-monitoring visits, data listings review)
Coordinate Independent Safety Committees

Skills

Clinical Trial Management

ICH GCP

FDA Regulations

EMA Regulations

CRO Management

Vendor Oversight

Study Budgeting

Site Contracting

Protocol Development

Clinical Study Reports

Cross-Functional Team Management

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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