Manager of Clinical Data Management

The Manager of Clinical Data Management at Oruka Therapeutics oversees all data management activities for clinical trials. This includes ensuring compliance with regulatory standards, managing CRO relationships, and developing key documentation necessary for effective data flow. The role also involves problem-solving and coordination to ensure data accuracy through the trial phases.

To be considered for the Manager of Clinical Data Management position at Oruka Therapeutics, you should possess a Bachelor’s degree in a science-related field or computer systems, with at least 8 years of experience in clinical research and 5-6 years specifically in data management. Familiarity with CDISC standards and EDC software like Medidata and Oracle is beneficial.

To ensure data quality, the Manager of Clinical Data Management at Oruka Therapeutics is responsible for establishing data validation checks, conducting regular reviews of all study data, and managing data cleaning processes. Collaboration with CROs and internal teams is vital for identifying and resolving data issues efficiently.

The Manager of Clinical Data Management position at Oruka Therapeutics offers both remote and hybrid options. Candidates residing near the Waltham, MA office will be required to work on-site 3 days a week, while those outside of commuting distance may work remotely with periodic trips to the office.

At Oruka Therapeutics, the Manager of Clinical Data Management can expect numerous opportunities for professional growth and development. We have a vibrant company culture that supports learning and collaboration, ensuring that our team members can enhance their skills and advance their careers while directly impacting patient care.

When answering this question, focus on specific roles you've held and your responsibilities in data management. Detail your familiarity with EDC systems and how you ensured data integrity throughout trials, emphasizing any successes or challenges you overcame.

To effectively respond, discuss strategies you use for task prioritization. Mention using project management tools or methodologies, setting clear deadlines, and how you communicate with teams to ensure alignment on priorities.

Explain the processes you follow to stay compliant with regulations. Talk about your experience with SOPs, working with regulatory bodies, and conducting audits to ensure all documentation and data handling meet necessary standards.

Describe your approach to conflict resolution, emphasizing communication and collaboration. Share specific examples where you successfully navigated challenges and maintained productive relationships with CROs.

Provide examples of the key documents you've developed, such as Data Management Plans or data validation specs. Discuss your approach to creating these documents and how they contribute to the overall quality of clinical trials.

Share a detailed story about a specific project, focusing on your role, the strategies you implemented, and the results achieved. Highlight any metrics that demonstrate the project's success and what you learned from the experience.

Discuss how you collect feedback from team members and stakeholders, emphasizing the methods you use for continuous improvement. Share any frameworks or systems you have in place to integrate feedback effectively.

List the software and tools you are proficient in, such as SAS, R, or specialized EDC systems. Discuss how you utilize these tools to analyze data effectively and generate reports for stakeholders.

Explain your methods for ensuring clear communication, such as regular meetings, updates through email or project management platforms, and establishing clear channels for questions and feedback.

Articulate your passion for the organization’s mission and how your values align with its goals. Discuss specific aspects of the role that excite you and contributions you envision making to the team and patient outcomes.