CDC II

The CDC II is the point of contact for day to day activities on a study with key responsibilities to handle the study independently. Reporting to Group Lead/Manager.

• Review CRF/eCRF data for completeness, accuracy and consistency via computerized edits and manual data checks.
• Generate and close/resolve data queries. Freeze and /or lock eCRFs (as appropriate) within the electronic data capture system.
• In accordance with project specific timelines to perform data management activities to ensure the generation of accurate, complete and consistent clinical database.
• To train and guide less experienced clinical data coordinators in data management requirements and activities.
• Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager (CDL) where needed. Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.
• Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards
• Performs DM activities for start up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT). Manage local lab set up for the Clinical Database as applicable
• Performs DM hands on activities during the course of the study. Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
• Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation. Supports and assists Junior staff for assigned trials
• Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner
• Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence. Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks). Ensures adherence to GCP, DM standards, SOPs/WPS and process guidelines
• Complete all assigned trainings ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies. Record all billable and non-billable time in the appropriate timesheet management system.

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• Minimum 4 - 6 Years of experience in core DM activities
• Ability to work under pressure demonstrating agility through effective and innovative team leadership
• Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
• Excellent problem-solving skills
• Excellent verbal and written skills