Hybrid Associate Director, Clinical Data Management

Clinical Dynamix, Inc.; Waltham (MA); Hybride; USD 140 000 - 210 000; Plein temps

Résumé du poste

Clinical Dynamix, Inc. in Waltham, MA is seeking an Associate Director of Clinical Data Management to define and lead the CDM strategy, overseeing start-up and execution of complex trials with CROs while ensuring data quality and regulatory compliance.

You will manage eCRF design, data validation, and data management plans, coordinate with cross-functional teams, and drive data integrity throughout the trial lifecycle.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree a plus
• 10+ years in biotech/biopharma and/or CRO
• Experience with CDM systems, EDC, and CDISC data standards
• Experience managing multiple CROs/vendors
• Strong written and verbal communication skills
• Proactive, detail-oriented, able to drive for results

Responsabilités

• Drive development of databases and eCRF design
• Plan and implement UAT, data specs, data entry guidelines
• Develop data validation guidelines for accurate data collection
• Review eCRF changes and coordinate database updates
• Oversee start-up and execution of trials with CROs/vendors
• Ensure data quality and timeliness of CDM deliverables
• Manage clinical trial data queries and SAE reconciliation
• Maintain data integrity in compliance with GCP and regulatory requirements
• Collaborate with cross-functional stakeholders to meet timelines
• Develop data management SOPs aligned with business priorities
• Uphold data integrity and compliance

Connaissances

Data management

Communication

Attention to detail

Independent worker

Project coordination

GCP knowledge

Formation

Bachelor’s degree in a scientific discipline

Outils

Microsoft Office

SharePoint

Description du poste

Clinical Dynamix, Inc. in Waltham, MA is seeking an Associate Director of Clinical Data Management to define and lead the CDM strategy, overseeing start-up and execution of complex trials with CROs while ensuring data quality and regulatory compliance.

You will manage eCRF design, data validation, and data management plans, coordinate with cross-functional teams, and drive data integrity throughout the trial lifecycle.