Senior Clinical Data Manager - REMOTE ROLE

POSITION SUMMARY

The Senior Clinical Data will serve as a key member of the data management team. Provide subject matter expertise of data management activities in support of our client’s needs and projects. The Senior Clinical Data Manager will ensure completeness, accuracy and overall quality of the data.

Responsibilities

• Provides operational support for Data Operations
• Represents Data Management on project teams. Manages scheduling of deliverables across multiple projects from data base creation to database lock
• Reviews study protocol(s) to ensure that data collection and CRF design meet study objectives
• Management and creation and maintenance of all essential data management documentation including but not limited to: database specifications (CRF specifications, edit checks, skip logic), UAT Scripts, CRF Completion Guidelines, Data Management Plans
• Ensure data quality of clinical database through database lock with ongoing data review
• Review and reconcile any data received from external sources (SAE, Labs, ECG, etc.)
• Maintain local lab normal ranges. Complete reference range data entry, updating. Manages review of local lab data as part of the DM cleaning activities
• Supports and provides cross-functional collaboration and communications to increase quality of deliverables
• Provide training to project team and sites on EDC and study specific content
• Identifies DM activities outside the scope of contracted work, prepares cost analysis documentation and follows scope issues through to resolution
• Keeps sponsor and team members aware of potential project risks and crafts mitigation strategies with the internal project team to proactively address issues
• Creates and maintains complete and up-to-date study documentations in compliance with WuXi Clinical and regulatory standards
• Recommends technical and process solutions that can be used or developed to increase efficiency of project work
• Adherence to timelines and budgets
• Organization and coordination on multiple projects
• Train and mentor junior level staff in general team leadership skills, company processes, and project specific tasks
• Good understanding of departmental and company procedures which relate to tasks that are performed routinely
• May provide technical leadership and coordination of data-related project activities to other team members
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
• Works under close supervision from supervisor or senior personnel
• Ability to work in a team environment and independently as required
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures
• Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations
• Other duties as assigned
• May be required to assist in other departments

Education and Experience

BS or MS in Life Sciences or technical degree with 5 years DM experience is preferred within the pharmaceutical/biotech industry (Ideal candidate will have 10 or more years of experience and/or combination of experience and education) Must have some experience with DM start up, maintenance and closeout activities in both paper and EDC studies Ability to demonstrate knowledge of Good Clinical Practices (GCP), and International Conference on Harmonisation (ICH)

PLEASE NOTE: We are also seeking to fill Clinical Data Manager II's and Clinical Data Analysts positions.  Please refer to the WuXI Career site for more details.