Job Description
Clinical Data Manager Job Title Clinical Data Manager
Job Summary We are seeking a detail-oriented Clinical Data Manager to oversee the collection, validation, management, and quality of clinical trial data throughout the study lifecycle. The ideal candidate will work closely with clinical operations, biostatistics, medical, and regulatory teams to ensure clinical data is accurate, complete, and compliant with applicable regulatory standards and Good Clinical Practice (GCP) guidelines.
Key Responsibilities - Develop and maintain clinical data management plans (DMPs) for clinical studies.
- Design, review, and validate electronic Case Report Forms (eCRFs) and clinical databases.
- Coordinate data collection, cleaning, validation, reconciliation, and database lock activities.
- Create and maintain data validation rules and edit checks to ensure data quality.
- Review and resolve data queries in collaboration with clinical sites and study teams.
- Perform data reconciliation with external vendors, laboratories, imaging providers, and safety databases.
- Ensure compliance with study protocols, GCP, SOPs, and regulatory requirements.
- Support User Acceptance Testing (UAT) for clinical data management systems.
- Generate data quality metrics, status reports, and study progress updates.
- Collaborate with clinical operations, biostatistics, statistical programming, pharmacovigilance, and regulatory affairs teams.
- Participate in database lock, data transfers, and study closeout activities.
- Maintain complete and accurate study documentation and audit-ready records.
Required Qualifications - Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Health Sciences, Computer Science, or a related field.
- 2-5 years of experience in clinical data management or clinical research.
- Strong knowledge of clinical trial processes and clinical data management practices.
- Familiarity with Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
- Experience with Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle InForm, Veeva, or REDCap.
- Knowledge of clinical database design, data validation, query management, and database lock procedures.
- Proficiency in Microsoft Excel and clinical reporting tools.
- Basic understanding of SQL or SAS is an advantage.
- Strong analytical, organizational, and problem-solving skills.
Preferred Qualifications - Experience working with CROs, pharmaceutical companies, or biotechnology organizations.
- Knowledge of CDISC standards, including SDTM and CDASH.
- Familiarity with clinical coding dictionaries such as MedDRA and WHO Drug.
- Experience supporting multiple clinical trial phases (Phase I-IV).
- Certification in Clinical Data Management or Clinical Research is preferred.
- Experience participating in regulatory inspections or sponsor audits.
Technical Skills - Electronic Data Capture (EDC) Systems
- Medidata Rave
- Oracle InForm
- REDCap
- Veeva Vault
- Microsoft Excel
- SQL (basic)
- SAS (preferred)
- Clinical Trial Management Systems (CTMS)
- Microsoft Office Suite
Soft Skills - Strong attention to detail and data accuracy.
- Excellent analytical and problem-solving skills.
- Effective communication and cross-functional collaboration.
- Strong organizational and time management abilities.
- Ability to manage multiple studies and deadlines.
- Commitment to regulatory compliance and data integrity.
Nice to Have - Experience with risk-based monitoring and centralized data review.
- Knowledge of pharmacovigilance and safety data reconciliation.
- Familiarity with electronic Trial Master File (eTMF) systems.
- Experience with AI-enabled clinical data review or analytics tools.
- Understanding of clinical study reporting and submission requirements.
Benefits - Competitive salary and performance-based incentives.
- Comprehensive health and wellness benefits.
- Paid time off and flexible work arrangements.
- Professional development, certification, and training opportunities.
- Opportunity to work on global clinical trials and innovative therapies.
- Collaborative and quality-focused work environment.
Job Tags
Work at office, Remote work, Flexible hours