Lead Clinical Data Management - Remote

oruka; United States; Hybride; USD 120 000 - 180 000; Plein temps

Résumé du poste

Oruka Therapeutics, a Nasdaq-listed biotech, seeks an experienced Manager, Clinical Data Management to lead data management across Phase I–IV studies. You will ensure timely delivery of high-quality data in compliance with ICH‑GCP and SOPs, and act as the primary DM lead for assigned trials.

In a remote or hybrid role (office in Waltham, MA when onsite), you will oversee CROs, study start-up, database development, data cleaning, and final database lock, collaborating with Biometrics, Statistics,

Responsabilités

• 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.
• Oversee the design, development, testing, and validation of clinical databases, including User Requirements, electronic Case Report Forms (eCRFs), edit checks, data validation specifications, and User Acceptance Testing (UAT).
• Review and approve key data management documentation, including: Data Management Plans (DMPs), Case Report Forms (CRFs), CRF Completion Guidelines, Manual Data Review Guidelines, Edit Check Specifications, Data Validation Specifications, Other study-specific data management documentation.
• Participate in the development and review of specifications for related clinical technologies, including eCOA/ePRO and IRT/IVRS systems.
• Oversee all study-related data cleaning activities, including reconciliation of external data sources such as laboratory, ECG, imaging, eCOA/ePRO, and other vendor data.
• Ensure clinical and external data meet quality standards required for interim analyses, database freezes, unlocks, and final database lock.
• Conduct ongoing internal review of study data throughout study conduct to proactively identify and resolve data quality issues.
• Maintain the internal Data Review Log and collaborate with CROs to ensure timely resolution of all outstanding queries and data issues.
• Partner with Biometrics, Statistical Programming, and Biostatistics to develop oversight listings, patient profiles, reports, and programming checks that support efficient data review.
• Provide oversight of Data Management CROs and external vendors to ensure high-quality deliverables, adherence to timelines, and compliance with contractual obligations.
• Review Statements of Work (SOWs), Requests for Proposals (RFPs), budgets, and Change Orders for completeness, accuracy, and alignment with study objectives.
• Review vendor metrics, reconciliation reports, and quality indicators while ensuring timely escalation and resolution of identified issues.
• Ensure all data management activities comply with applicable regulatory requirements, ICH‑GCP guidelines, and Oruka Therapeutics SOPs.

Description du poste

Oruka Therapeutics, a Nasdaq-listed biotech, seeks an experienced Manager, Clinical Data Management to lead data management across Phase I–IV studies. You will ensure timely delivery of high-quality data in compliance with ICH‑GCP and SOPs, and act as the primary DM lead for assigned trials.

In a remote or hybrid role (office in Waltham, MA when onsite), you will oversee CROs, study start-up, database development, data cleaning, and final database lock, collaborating with Biometrics, Statistics,