Overview
Join our dynamic team as a Clinical Data Management Manager and lead the charge in ensuring the integrity, accuracy, and compliance of clinical trial data. This pivotal role involves overseeing data collection processes, managing clinical data teams, and ensuring adherence to regulatory standards such as FDA regulations, ICH GCP guidelines, and HIPAA compliance. As a key driver of clinical development projects, you will facilitate seamless data management workflows, support clinical trials management, and uphold the highest standards of quality in research environments. Your expertise will directly impact the success of innovative medical research and patient care advancements. Duties
- Design, review, and maintain clinical trial databases and electronic Case Report Forms (eCRFs)
- Develop and review Data Management Plans (DMPs), edit check specifications, and data validation rules
- Perform data cleaning, discrepancy management, and query resolution activities
- Ensure accuracy, consistency, and completeness of clinical trial data
- Conduct User Acceptance Testing (UAT) for clinical database systems
- Coordinate data transfers with external vendors and reconcile external data
- Support database lock activities and archival processes
- ICH-GCP guidelines
- CDISC standards
- SOPs and regulatory requirements
- Generate status reports and metrics related to data management activities
- Participate in study meetings and cross-functional collaboration
- Assist during audits and regulatory inspections
Required Qualifications
- Bachelor’s degree in:
- Life Sciences
- Pharmacy
- Biotechnology
- Nursing
- Health Sciences
- Related field
- 0–4 years of experience in clinical data management
- Knowledge of clinical trial processes and regulatory requirements
- Experience with EDC systems such as:
- Medidata Rave
- Oracle Clinical
- Veeva Vault
- OpenClinica
- Familiarity with:
- CDISC standards (SDTM/CDASH)
- GCP guidelines
- Clinical trial lifecycle
- Strong analytical and problem-solving skills
- Excellent attention to detail and organizational skills
- Good communication and teamwork abilities
Preferred Qualifications
- Certification in Clinical Data Management (e.g., CCDM)
- Experience in oncology, cardiology, or other therapeutic areas
- Knowledge of SQL, SAS, or data visualization tools is a plus
- Develop and review Data Management Plans (DMPs), edit check specifications, and data validation rules
- Perform data cleaning, discrepancy management, and query resolution activities
Pay: $60,000.00 - $65,000.00 per year
Work Location: In person
