Clinical Data Management Lead

The Clinical Data Management Lead will provide leadership and guidance when ensuring the data is collected, managed, and reported clearly, accurately, and securely.

RESPONSIBILITIES

• Provide Data Management (DM) leadership across assigned trial(s)
• Prepare the eCRF, Data Handling Plan, Data Review Plan, and perform user acceptance testing
• Share feedback to assure well written protocols and amendments
• Recognize and resolve protocol issues that may impact database design, data validation, and/or analysis and reporting
• Track and report status and progress for assigned trials and indications
• Distribute study level information to the Clinical Trial Team
• Ensure consistency of assigned trials with program level standards across DM documentation
• Verify third-party and other necessary reconciliation activities are performed for the study in a timely manner
• Add input into DM initiatives and innovations for quality, efficiency, and continuous improvement
• Work cross-functionally amongst teams to ensure all data management activities meet corporate objectives and adhere to GCP, DM standards, SOPs, and other process guidelines
• Define and implement the study data cleaning/validation strategy and integrate a risk-based approach

Requirements

• 8+ years experience as CDM and MINIMUM 2 year with direct reports
• Managing studies, people management, project management (budgets/financial oversight), client facing, may assist in BD efforts
• Managing 5-8 studies at once
• Phase 1 primarily so will only have 10-15 patients
• Managing a team of 10-15 CDTL, Sr. CDTL and associate CDM
• Report into AD or Director of CDM
• EDC: rave
• Location: 100% remote
• Salary: $120-130K (flex for right candidate)
• Degree: preferred but flex for strong CDM exp.

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA, Europe and Asia Pac. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organizations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Practice Lead Arlen Morgan on +1 (980) 819-2224, or email amorgan@i-pharmconsulting.com. If this role is not suitable, Arlen is also available to discuss other possible positions or answer any general questions regarding your career and the current market.