Sr. Clinical Trial Manager at Abata Therapeutics

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Experience managing all aspects of clinical study progress (from vendor selection, protocol development and planning to study close-out, including supporting clinical study reports)
Knowledge of FDA, EMA, ICH GCP guidelines, and SOPs
Experience managing FSP site monitors, reviewing trip reports, overseeing visit cadence, conducting oversight visits, and resolving site management activities
Ability to manage cross-functional study teams and external vendors/stakeholders (e.g., CROs, central labs, IRBs/ECs)
Experience evaluating, selecting, and overseeing CROs and external vendors
Skills in communicating with clinical trial sites to maintain Sponsor-Site relationships
Ability to communicate trial status for cross-functional alignment on expectations, priorities, and deliverables (e.g., enrollment, monitoring, compliance, data metrics)
Experience leading clinical study budgeting and site contracting processes
Proficiency in tracking vendor performance against scopes of work, contracts, and invoices
Ability to facilitate review of scopes of work, invoices, change requests, and change orders
Capability to anticipate, recognize, and manage issues/risks, with judgment on escalation to Senior Management
Skills in analyzing study and site risks and implementing corrective actions
Experience driving quality-by-design to manage risks and ensure inspection readiness
Ability to lead development and execution of operational activities in study plans, SOPs, and procedures
Experience coordinating development and distribution of critical study documents (e.g., ICFs, operational documents, reference documents, newsletters, site materials)

Responsibilities

Manage all aspects of study progress (from vendor selection, 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
Manage FSP site monitors to achieve study milestones, including reviewing trip reports, overseeing visit cadence, conducting oversight visits, and assisting Associate Director in site management
Collaboratively manage cross-functional study team activities and communications with external vendors/stakeholders (e.g., CROs, central labs, IRBs/ECs)
Evaluate, select, and oversee CROs and external vendors
Communicate with clinical trial sites to ensure optimal Sponsor-Site relationships
Communicate trial status within and outside the study team for cross-functional alignment on expectations, priorities, and deliverables (e.g., enrollment, monitoring, compliance, data metrics)
Lead clinical study budgeting and site contracting process with legal team
Provide input to study-level budgets and manage assigned budgets by tracking vendor performance, scopes of work, contracts, invoices; facilitate reviews of scopes, invoices, change requests, and orders
Anticipate, recognize, and manage issues/risks; seek assistance or inform Senior Management as needed
Determine appropriate decision-making level (study team vs. escalation to Senior Management)
Analyze clinical study and site risks and implement corrective actions
Drive quality-by-design to identify/manage risks and ensure MapLight inspection readiness
Lead development and execution of operational activities in study plans, SOPs, study procedures
Coordinate development and distribution of critical study documents (e.g., ICFs, operational documents, study reference documents, newsletters, site materials)

Skills

Clinical Trial Management

Protocol Development

Vendor Management

GCP Compliance

FDA Regulations

EMA Regulations

ICH Guidelines

Site Monitoring

SDV

Trip Report Review

Oversight Visits

Study Close-out

Clinical Study Reports

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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