Senior Manager, Clinical Data Management (Remote)

Oruka Therapeutics Inc; Boston (MA); Ibrido; USD 146.000 - 161.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary & benefits

Vibrant startup culture

Professional growth opportunities

Inclusive team environment

Descrizione del lavoro

Oruka Therapeutics is seeking an experienced Manager of Clinical Data Management to lead data management across multiple trials and ensure high-quality, regulatory-compliant data. The role partners with CROs and internal teams to drive timelines, data standards, and data integrity throughout study lifecycles.

The ideal candidate will have a strong background in EDC systems, data standards, and cross-functional collaboration within a sponsor/CRO setting, with a focus on delivering robust data for

Competenze

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related scientific discipline.
• 10+ years of clinical research experience, including at least 5 years in Clinical Data Management.
• Experience leading Data Management activities across Phase I-IV clinical trials.
• Demonstrated experience managing CROs and external vendors.
• Strong understanding of GCP, ICH Guidelines, FDA, EMA, PMDA, and other regulatory requirements.
• Excellent organizational, analytical, project management, and communication skills.

Mansioni

• Lead and oversee data management activities across assigned studies.
• Develop and manage study timelines with CRO partners to meet milestones.
• Oversee design, development, testing, and validation of clinical databases and eCRFs.
• Review DMPs, CRFs, and data validation specifications.
• Ensure data quality for interim analyses, database locks, and CSR preparation.
• Coordinate with Biometrics, Statistical Programming, and Biostatistics teams.

Conoscenze

Leadership

Project management

Communication

Problem-solving

Formazione

Bachelor's degree in Life Sciences/CS/IT

Strumenti

Medidata Rave

Oracle Clinical

Medrio

Veeva CDMS

eTMF

Descrizione del lavoro

Oruka Therapeutics is seeking an experienced Manager of Clinical Data Management to lead data management across multiple trials and ensure high-quality, regulatory-compliant data. The role partners with CROs and internal teams to drive timelines, data standards, and data integrity throughout study lifecycles.

The ideal candidate will have a strong background in EDC systems, data standards, and cross-functional collaboration within a sponsor/CRO setting, with a focus on delivering robust data for