Assistant Director, Clinical Data Management

Location: Texas, USA
Job Type: Permanent
Specialisation: Life Sciences
Salary: Negotiable
Reference: BBBH2002_1634052946
Contact: Jessica Charles
Email: email Jessica
Role: Assistant Director, Clinical Data Management

Looking for an experience Clinical Data Manager to join a mid-size consulting and reimbursement company assisting both pharmaceutical and biotechnology manufacturers to thrive in the global healthcare markets. They have supported more than 30 countries and contributed to nearly 600 global projects with their area of expertise including health economics and outcomes research, reimbursement and global market access strategy, market research, and health policy analysis, as well as the development of value demonstration tools, scientific publications, training programs and outsourced field reimbursement teams.

Responsibilities:
Accountable for oversight of all data management deliverables including the design of CRFs and associated annotated CRFs in accordance with the final study protocol and building eCRFs independently using selected EDC platform
Develops user acceptance testing (UAT) specifications and testing plans in support of EDC deployment. Ensures all documentation is in place prior to EDC deployment
Works with the study analyst to develop statistical analysis plans (SAP), tables, listings, and figures (TLF)
Responsible for maintaining Data Management component of Trial Master File
Ensures adherence to protocol, ICH, GCPs, SOPs
Contributes to the development and/or revision of Clinical Data Management SOPs and related documentation

Requirements:
BSc in Life Science degree
Broad technical knowledge of outcomes research and health economics
8 years+ of hands-on CDM experience
Experience of data building, testing and deployment of e-CRFs using various EDC platforms
Strong working knowledge of GCPs and Federal Regulations
Understanding of medical term coding concepts (WHO, MedDRA)
SAS programming skills (desirable)


If this sounds of interest, please reach out to me at 01737 236729 /