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Manager of Clinical Data Management

Remote

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 in Waltham, MA office, will be required 3 days/week if located near office.          

Role Overview: 

Oruka Therapeutics is currently looking to expand its team and is searching for an individual to support our expanding Clinical Trial portfolio.

The Manager of Clinical Data Management (CDM) role is responsible for providing data management support to the Oruka Therapeutics, Inc clinical development program. This will be done while maintain high quality standards and in compliance with Regulatory Authorities’ regulations/guidelines and Oruka Therapeutics SOPs/Working Practices. The Manager, CDM will be the lead data manager for 3 to 4 studies based on study start up, maintenance or database lock phase. The candidate will report to the Sr. Director of Data Management.

Key Responsibilities: 

  • Responsible for the oversight of all data management CRO activities supporting Oruka Therapeutics, Inc clinical programs from database start-up through database lock and CSR/submission.
  • Primary point of contact with the DM CROs, 3rd party vendors and internal study teams.
  • Develop study timelines in conjunction with the internal team and DM CRO and ensure all DM related deliverables are met.
  • Oversee the development of the clinical database (DB), including user requirements, eCRF, edit rules/checks, data validation and User Acceptance Testing.
  • Oversee the development of key data management documents such as case report forms (CRF), data validation specifications, manual data review guidelines, CRF Completion Guidelines, programable edit checks, Data Management Plans (DMP) and other related documents. Ensures compliance with these study documents.
  • Participate in the development of other study related systems such as ePRO/eCOA and IVRS study specifications.
  • Oversee all study related data cleaning activities including reconciliation with all external databases.
  • Responsible for the review and accuracy of the study statement of work, RFPs, budgets, and Change Orders.
  • Work with the CRO to ensure the clinical data within EDC and all external data (ex: ePRO; Labs; EKG) are in good quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock.
  • Work within the Biometrics group to create and implement oversight listings, reports, programing checks and/or patient profiles.
  • Responsible for the internal review of all data regularly during study conduct leading to database lock.
  • Responsible for the maintenance of Oruka internal Data Review Log and working with DM vendor to get all issues resolved.
  • Participate in the review of various Clinical research documents (e.g. Protocols, Safety Monitoring Plans, Communication Plans).
  • Responsible for the review of all DM CRO metrics, reports and reconciliation logs to ensure quality and escalation/resolutions of issues are done in a timely matter.
  • Develop, tracks, analyze and report, as applicable, on data management performance metrics from study start to database lock.
  • Trouble shoots any data-related issues and finds immediate solutions.
  • Create, present, and implement lessons learned related to DM activities for process improvement.
  • Assist/participate in the preparation and oversight of study audits/inspections both internal and external.
  • Responsible for the oversight of all DM documents in the TMF (Trial Master File) or eTMF.
  • Attend and present during Study Kick Off meetings and/or Investigator Meetings
  • Responsible for creating and maintaining meeting minutes for internal DM lead meetings/decision logs.
  • Provide input during the development and/or review of Data Management SOPs, Work Instructions and templates/standards incorporating the industry’s best practices and any applicable Regulatory guidelines and requirements.

Qualifications:

  • Bachelor’s degree in a science related field and/or computer systems/IT background.
  • At least 8-yrs experience in clinical research (Site, Sponsor, CRO level) and 5-6 direct data management experience
  • Familiarity with CDISC/CDASH including the SDTM model a plus but not required
  • Familiarity with standard international coding dictionaries (e.g. WHODD, MedDRA)
  • Familiarity with Pinnacle 21 a plus but not required.
  • Experience with Electronic Trial Master file
  • Strong experience with various EDC software such as Medidata RAVE, Medrio, Oracle, Veeva CDMS as well as different IXRS and eCOA/ePRO systems a plus.
  • Ability to handle multiple tasks and to prioritize based on timelines. Strong organizational and project management skills a must.
  • Strong experience with Microsoft Word, Excel, PowerPoint and other Microsoft tools
  • Strong experience working with CROs and with vendor oversight.
  • Ability to interact effectively with various functions such as Clinical Operations, Medical, Regulatory, Safety, Quality Assurance, Programming, and Biostatistics.
  • Experience with working in clinical research and experience working in Phase I-IV study trials.
  • Excellent verbal and written skills, good organizational, interpersonal, and team skills.  
  • Must be able to work independently and report to the Sr. Director of DM, as appropriate.
  • Critical thinking and problem-solving a must
  • Strong knowledge of Good Clinical Practices, Clinical research, Clinical Trial process and related regulatory requirements and terminology both US and outside US.
  • Strong knowledge of regulatory agencies requirements such as the FDA, EMA, PMDA and others.
  • Regulatory Inspection and sponsor/vendor audit experience a plus.

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 $140,000 to $155,000. 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.

Location:

  • Hybrid, with 2-3 days in the office if within commuting distance of SF Bay Area or Boston location OR
  • Remote with up to 2 trips (2-3 days each) per month to office if not within commuting distance of SF Bay Area or Boston location

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

$140,000 - $155,000 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.

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