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Manager, Clinical Data Management
Oruka Therapeutics. Lead and oversee clinical data management activities across assigned Phase I-IV clinical studies .
Posted 10/6/2026full-timeWaltham • Massachusetts • United StatesSeniorLead💰 $146,000 - $161,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Clinical Data Management, overseeing Phase I-IV clinical studies, ensuring compliance with regulatory requirements, and managing CROs and vendor relationships. Proficient in utilizing Electronic Data Capture systems and maintaining data quality throughout the clinical trial process.
Highest-signal resume keywords
Clinical Data ManagementElectronic Data Capture (EDC) SystemsRegulatory Compliance (GCP, ICH)CRO ManagementData Quality Assurance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Data ManagementData ValidationDatabase DesignData CleaningStatistical ProgrammingProject ManagementData Management PlansECRF DevelopmentInterim AnalysisPerformance Metrics
Soft Skills
Organizational SkillsAnalytical SkillsProblem-Solving SkillsCommunication SkillsCollaboration Skills
Tools & Technologies
Medidata RaveOracle ClinicalMedrioVeeva CDMSETMF
Industry Keywords
Clinical ResearchPhase I-IV TrialsBiotechnologyPharmaceuticalFDA RegulationsEMA GuidelinesPMDA ComplianceData Management TMF
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- Lead and oversee clinical data management activities across assigned Phase I-IV clinical studies
- Serve as lead Clinical Data Manager for approximately three to four studies across study start-up, conduct, database lock, and closeout
- Oversee CRO and vendor data management activities, timelines, deliverables, budgets, and contractual obligations
- Oversee design, development, testing, and validation of clinical databases, eCRFs, edit checks, data validation specifications, and UAT
- Review and approve Data Management Plans, CRFs, completion guidelines, review guidelines, edit check specifications, and related documentation
- Oversee data cleaning and reconciliation of laboratory, ECG, imaging, eCOA/ePRO, and other vendor data
- Ensure data quality for interim analyses, database freezes, unlocks, and final database lock
- Maintain data review logs and resolve queries and data issues with CROs
- Partner with Biometrics, Statistical Programming, and Biostatistics on listings, reports, patient profiles, and programming checks
- Ensure compliance with regulatory requirements, ICH-GCP guidelines, and company SOPs
- Maintain Data Management TMF/eTMF documentation and support audits and regulatory inspections
- Develop and report data management performance metrics and implement process improvements
- Lead or participate in study kick-off, investigator, vendor, and cross-functional meetings
- Build relationships across Clinical Operations, Medical, Safety, Regulatory Affairs, Quality Assurance, Biostatistics, Statistical Programming, and external partners
- Report to the Senior Director, Data Management
Requirements
What you’ll need- Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related scientific discipline
- Minimum of 10 years of clinical research experience, including at least 5 years of direct Clinical Data Management experience within a Sponsor, CRO, or biotechnology/pharmaceutical environment
- Experience leading Data Management activities across Phase I-IV clinical trials
- Demonstrated experience managing CROs and external vendors
- Strong experience with Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle Clinical, Medrio, Veeva CDMS, or comparable platforms
- Experience with electronic Trial Master Files (eTMF)
- Strong understanding of GCP, ICH Guidelines, FDA, EMA, PMDA, and other applicable global regulatory requirements
- Experience reviewing clinical databases, edit checks, CRFs, Data Management Plans, and database validation documentation
- Excellent organizational, analytical, project management, and problem-solving skills
- Strong written and verbal communication skills with the ability to collaborate effectively across multidisciplinary teams
- Ability to independently manage multiple clinical studies and competing priorities in a fast-paced environment
Benefits
Comp & perks- Competitive salary and benefits package
- Equity
- Performance-related bonus opportunity
- Supportive and inclusive team environment
- Opportunities for professional growth and development
- Vibrant startup culture
- Opportunity to directly impact bringing new medicines to patients