Manager, Clinical Data Management

The posting, as Oruka Therapeutics wrote it

About Us

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Job Title: Manager of Clinical Data Management

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

Role Overview

Oruka Therapeutics is seeking an experienced and highly motivated Manager, Clinical Data Management, to support our expanding clinical development portfolio. This position is responsible for leading and overseeing all clinical data management activities across assigned clinical studies, ensuring the delivery of high-quality, reliable clinical data in compliance with applicable regulatory requirements, ICH-GCP guidelines, and Oruka Therapeutics Standard Operating Procedures (SOPs).

The Manager will serve as the lead Clinical Data Manager for approximately three to four clinical studies across various stages of the study lifecycle, including study start-up, conduct, database lock, and closeout. This individual will collaborate closely with cross-functional teams, CRO partners, and external vendors to ensure the successful execution of data management deliverables while maintaining quality, timelines, and budget.

This position reports to the Senior Director, Data Management.

Key Responsibilities

Clinical Data Management Leadership

• Serve as the lead Clinical Data Manager for assigned Phase I-IV clinical trials.
• Provide strategic oversight of all CRO data management activities from database start-up through database lock, clinical study report (CSR), and regulatory submission.
• Serve as the primary Data Management representative and point of contact for CROs, third-party vendors, and internal cross-functional study teams.
• Develop and manage study timelines in collaboration with internal teams and CRO partners to ensure all data management milestones and deliverables are achieved.

Database Development & Study Start-Up

• Oversee the design, development, testing, and validation of clinical databases, including User Requirements, electronic Case Report Forms (eCRFs),

[…]
icable global regulatory requirements.

• Experience reviewing clinical databases, edit checks, CRFs, Data Management Plans, and database validation documentation.
• Excellent organizational, analytical, project management, and problem-solving skills.
• Strong written and verbal communication skills with the ability to collaborate effectively across multidisciplinary teams.
• Ability to independently manage multiple clinical studies and competing priorities in a fast-paced environment.

Preferred

• Working knowledge of CDISC standards, including CDASH and SDTM.
• Familiarity with Pinnacle 21.
• Experience with eCOA/ePRO and IRT/IVRS systems.
• Experience supporting regulatory inspections and sponsor/vendor audits.
• Previous experience mentoring or leading Clinical Data Managers is preferred.

Compensation

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $146,000 to $161,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.
Salary Range for the Role
$146,000 — $161,000 USD

What We Offer

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.