Clinical Trials Data Management Lead — Client-Facing

ClinChoice; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

ClinChoice is seeking a Senior Data Manager Consultant to lead data management activities for clinical trials, including database setup, study conduct, and close-out. You will collaborate with a cross-functional team to deliver high-quality DM deliverables and meet timelines.

Responsibilities include creating DM documents, developing eCRF specifications, testing data entry screens, and training clinical teams and sites, while maintaining strong client relationships and adherence to GCP/ICH

Qualifications

• Minimum 3 years data management experience in pharmaceutical industry.
• Experience reviewing clinical trial documents (protocols, CRFs).
• Proficiency with eCRF design and data management deliverables.
• Familiarity with data quality checks, DB locks, and data reconciliation.

Responsibilities

• Lead data management activities to meet timelines and quality
• Review clinical study documents (protocols, CRFs)
• Create and review eCRF specifications
• Develop DM documents: DM Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines, Data Review Plan
• Develop edit rules, query logic and messages
• Develop UAT plan and test data entry screens
• Provide training to clinical team and sites
• Perform data reviews and patient tracking for data cleanup
• Coordinate database lock/unlock and final database lock
• Coordinate archival of study databases and related docs
• Create Data Transfer Specifications and perform external vendor reconciliation
• Maintain client satisfaction with high-quality data management services

Skills

Data management

eCRF development

DM plan development

Regulatory knowledge (GCP/ICH)

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field

Tools

Medidata Rave

Oracle InForm

OpenClinica

Medrio

Job description

ClinChoice is seeking a Senior Data Manager Consultant to lead data management activities for clinical trials, including database setup, study conduct, and close-out. You will collaborate with a cross-functional team to deliver high-quality DM deliverables and meet timelines.

Responsibilities include creating DM documents, developing eCRF specifications, testing data entry screens, and training clinical teams and sites, while maintaining strong client relationships and adherence to GCP/ICH