Manager of Clinical Data Management
$140k/y-$155k/y
2 days ago
Highlight
HybridFull-timeSenior
Summary
Oruka Therapeutics is seeking a Manager of Clinical Data Management to join their team in a Remote or Hybrid role based in Waltham, MA. The role involves providing data management support for clinical development programs while ensuring compliance with regulatory standards.
About the Role
As the Manager of Clinical Data Management, you will oversee data management activities for 3 to 4 clinical studies, ensuring high quality standards and compliance with regulatory guidelines. You will be the primary contact for CROs and internal teams, develop study timelines, oversee clinical database development, and manage data cleaning activities. Additionally, you will participate in the review of clinical research documents and ensure timely resolution of data-related issues.
About You
Required:
- Bachelor's degree in a science-related field or computer systems/IT background.
- At least 8 years of experience in clinical research and 5-6 years of direct data management experience.
- Strong experience with various EDC software such as Medidata RAVE, Medrio, Oracle, and Veeva CDMS.
Preferred:
- Familiarity with CDISC/CDASH and the SDTM model.
- Experience with Electronic Trial Master file and regulatory inspection experience.
Benefits
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- A supportive and inclusive team environment.
Oruka Therapeutics
Advancing novel biologics that aim to offer the greatest possible freedom from disease to people with plaque psoriasis and other associated conditions
Waltham, MA