Senior Clinical Data Manager

You will make an impact:

As a Senior Clinical Data Manager (Sr. CDM) you will independently act as a study lead and are responsible for the oversight, maintenance, and management of clinical trial database(s) for assigned projects through the full data management process life cycle. You are viewed as the CDM expert and will serve as the primary liaison between eClinical personnel and Sponsor personnel. You will create and oversee the database design specifications, validation, maintenance/data cleaning, and closeout activities of project-specific clinical trial databases. As a Senior Clinical Data Manager, you may delegate tasks/responsibilities to multiple team members in multiple projects. You will provide ongoing project oversight to ensure proper planning and timely completion of high-quality Sponsor deliverables.

Your day to day:

• Primary representative for eClinical Solutions and sponsor data management interaction
• Responsible for monitoring and ensuring adherence to study timelines and deliverables
• Accountable for the overall quality of data management activities and deliverables at the study or program level
• Ensure efficiency and consistency for data management tasks across programs
• Communicate with global study teams
• Participate in client study kickoff and closeout/lessons learned meetings
• Create materials for and present at Investigator Meetings
• Develop content and deliver Sponsor CRA and/or site training
• Delegate tasks, support and provide guidance to study data management team
• Oversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text
• Oversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specifications
• Participate in Internal System Testing (IST) on the database/user roles/edit check specifications
• Assist with preparation for implementation of a centralized data management platform for strategic data cleaning and reporting
• Utilization of centralized data management platform including graphical patient profiles and operational analytics
• Compile the sponsor UAT package
• Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications
• Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools
• Oversee and/or perform data review for overall consistency and accuracy
• Oversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database
• Oversee and/or perform query processing/resolution
• Provide ongoing data management reports and metrics
• Oversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study
• Define and develop specifications for database, programming and/or edit check changes as needed throughout the study
• Track data management issues and ensure follow up to resolution
• Identify data issues and/or data trends, communicate to the Clinical Data Management team and Sponsor, assist with development and implementation of action plan
• Maintain data management study documentation
• Perform steps pertaining to database freeze/lock and coordinate all related activities
• Ongoing evaluation of process and participate in process improvement
• Assist in the creation and review of SOPs, WIs, and training materials
• Mentor junior level staff and peers on all associated tasks within a study
• Participate in proposal defenses
• Perform other duties as requested by management

Qualifications:

• Bachelor’s degree in Pharmaceutical/Biotechnology or higher in health-related field preferred
• 8+ years in Clinical Data Management experience preferred
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology
• Strong project management experience and project team leadership skills including work planning and work delegation
• Experience with EDC and performing data management activities
• Excellent verbal and written communication skills
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Experience with EDC and Clinical Data Management Systems