Director/Senior Director, Clinical Data Management (Oncology)
- Position Title: Director/Senior Director, Clinical Data Management
- Department: Biometrics / Clinical Data Management / Clinical Development
-

Location:
[Hyderabad]
- Reports to: [e.g., Head of Biometrics / VP of Clinical Operations / Chief Medical Officer] Role Overview The Director/Sr. Director of Clinical Data Management will lead the end-to-end clinical data management strategy, execution, and operational oversight for oncology clinical development programs (Phase I through Phase III / Registrational studies). This individual will set departmental standards, manage internal CDM teams and external vendors/CROs, and ensure the highest standards of data integrity, quality, and regulatory compliance.

Key Responsibilities
Strategic & Operational Leadership
- Program Oversight: Own the clinical data management strategy, deliverables, and data integrity across a portfolio of complex oncology, immuno-oncology, or biomarker-rich trials (e.g., dose-escalation, antibody-drug conjugates, and late-phase studies).
- Team & People Management: Lead, mentor, and scale a global or local team of Clinical Data Managers, including managers and senior individual contributors.
- Modernization & Innovation: Drive CDM process modernization, including risk-based data review, automated data cleaning, advanced analytics, or AI/ML-enabled capabilities.
- Cross-Functional Collaboration: Partner closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Translational Science,



Pharmacovigilance, and Regulatory Affairs. Data Management Execution
- Oversee eCRF design, eCRF specifications, completion guidelines, annotated CRFs (aCRFs), edit checks, and User Acceptance Testing (UAT).
- Manage end-to-end data cleaning, query management, SAE (Serious Adverse Event) reconciliation between safety and clinical databases, and external data reconciliation (e.g., central lab, imaging, genomics).
- Ensure strict adherence to RECIST criteria, complex oncology endpoints, and protocol-specific data flows.
- Oversee database locks, freeze/unfreeze milestones, and data migration/archiving readiness for statistical analysis. Vendor & Resource Management
- Select, govern, and manage external CROs, Electronic Data Capture (EDC) providers, and third-party data vendors, evaluating scopes, timelines, budgets, and quality metrics.
- Oversee departmental budget forecasting, resource allocation, and vendor invoice reconciliation. Quality, Compliance & Regulatory Submissions
- Ensure all data management activities comply with ICH-GCP, GCDMP, 21 CFR Part 11, and relevant health authority regulations.
- Drive and support regulatory submissions (e.g., NDA, BLA, MAA)



and health authority inspections/audits.
- Author and maintain departmental Standard Operating Procedures (SOPs) and work instructions. Qualifications & Requirements Education
- Bachelors degree in Life Sciences, Data Science, Statistics, Computer Science, Health Informatics, or a related field; Advanced degree (MS/PhD/PharmD) preferred. Experience
- 15+ years of progressive experience in Clinical Data Management within the pharmaceutical, biotechnology, or CRO industry.
- Substantial oncology clinical trial experience, including early-phase (dose escalation/biomarker) and/or late-phase/registrational trials.
- 3+ to 5+ years of direct line management and leadership experience managing CDM staff, team leads, or external teams.
- Demonstrated experience supporting major regulatory submissions (NDA/BLA) and health authority inspections. Technical & Regulatory Knowledge
- Deep expertise in leading EDC platforms (e.g., Medidata Rave, Veeva EDC, Oracle Clinical).
- Strong command of CDISC standards (SDTM, CDASH, SEND) and medical coding dictionaries (MedDRA, WHODRUG).
- Thorough understanding of ICH-GCP, FDA/EMA regulations, and risk-based quality management (RBQM) approaches. Skills & Competencies
- Exceptional strategic thinking combined with a hands-on attitude when problem-solving complex data issues.
- Strong communication, negotiation, and cross-functional leadership skills.
- Ability to work in a fast-paced, agile biotech or pharma environment.

📌 Director Clinical Data Management(Oncology) (Hyderabad)
🏢 Maxis Clinical Sciences
📍 Hyderabad