- Perform and/or initiate comprehensive data management tasks, pertaining to Database design, programming, and validation and Data transfers.
- Perform quality control procedures for relevant activities.
- Assist in developing and implementing new technology in Database Design.
- Provide Clinical Data Management team with technical expertise.
- Develop and maintain good communication and working relationships with CDM team.
- Review the contract, protocol and any other customer specifications for implementing any client specifications.
- Perform tasks/activities as communicated by Clinical Programmer, SDM or Alliance Manager.
- Create/review the Data Management Plan documents.
- Attend/Conduct telephone conferences/meetings as required.
- Adherence to SOPs/Regulatory requirements/project specific guidelines.
- Escalation of identified unresolved issues to Clinical Programmer/SDM/ Alliance Manager.
- Provide inputs/status reports on monthly basis during the life cycle of the project.
- Knowledge transfer & sharing experience/lessons learned.
- Study Database Design/Build and Checks/procedure programming
- Review /update Study build specification documents.
- Build/amend & Validate Study database as per the study build specification documents.
- Program/modify checks/procedures as per the study build specification documents.
- Update and upload the relevant documents on shared client portal on completion of the tasks.
- Update the database for any QC/User acceptance test findings.
- RAVE Custom Functions Programming
- Knowledge for debugging Custom Functions through Medidata CF debugging utility
- Reviews the Data Validation Specification documents and Categorizes the Edit Checks and Custom Functions
- Strong Knowledge on Medidata Rave Custom Functions utility and program Custom Functions
- Has knowledge on various Simple to Complex Custom Functions.
- Work with Standards team and suggest updates/deviations on Standard Custom Functions used across studies.
- Analyze the Custom Function related issues in Production and provide effective solutions on fixing those issues.
- Performs the Peer Review of the Custom Function code developed by the other Custom Function Programmer
- Participate in knowledge sharing sessions and mentor/train the team on Custom Functions programming
- Excellent interpersonal and communication skills
- Capability to lead by motivation and example
- Ability to prioritize schedule and organize
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