Clinical Trial Manager/Senior Clinical Trial Manager

1w1 week ago

Oruka Therapeutics

Waltham, US · Full-time · $146,000 – $187,000

About this role

Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to set a new standard for chronic skin diseases like plaque psoriasis. The mission offers patients complete disease clearance with dosing as infrequently as once or twice per year. This role ensures trial compliance, regulatory alignment, and operational efficiency while advancing the clinical pipeline.

Independently manage clinical trials from initiation through completion, ensuring quality deliverables within budget and timeframe. Oversee preparation and review of protocols, informed consent forms, case report forms, and study reports. Collaborate with investigators, vendors, and cross-functional teams for study execution.

Drive cross-functional internal study teams with alignment, risk management, and coordination across functions. Interface with Data Management, Biostatistics, and Clinical Development for seamless monitoring and data cleaning. Partner with Program Management to develop and drive study timelines for setup and execution.

Join the core team at a growing company passionate about dermatologic innovation. Contribute to an engaged, inclusive, and positive culture. Be part of something bigger, making a difference for patients with chronic skin conditions.

Requirements

Experience independently managing clinical trials in pharmaceutical development
Strong knowledge of clinical trial compliance, regulatory requirements, and GCP guidelines
Proficiency in overseeing trial documentation such as protocols, ICFs, CRFs, and study reports
Demonstrated ability to lead cross-functional teams and manage study risks
Background collaborating with investigators, vendors, and CROs in trial execution
Familiarity interfacing with Data Management, Biostatistics, and Clinical Development functions
Expertise in biologics trials for dermatology or inflammatory diseases

Responsibilities

Lead and manage multiple clinical trials from initiation through completion, ensuring adherence to study timelines and budgets
Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence
Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports
Develop and drive cross-functional study timelines related to trial setup and execution in partnership with Program Management
Drive the cross-functional internal study team ensuring appropriate alignment, risk management, and coordination across all participating functions
Interface with Data Management, Biostatistics, and Clinical Development to ensure seamless monitoring and data cleaning initiatives to meet study deliverables

Benefits

Hybrid schedule with 3 days per week in office if near Waltham, MA or Menlo Park, CA
Remote work may be considered for qualified candidates
Opportunity to build core team and company culture
Mission-driven work advancing best-in-class antibodies for skin diseases