Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; communications; and milestone deliverables. Perform role of Data Team Lead (DTL).
Essential Functions
- Gather Study Set up requirements through discussion and communication with relevant stakeholders.
- Perform Database Set up and validation to ensure quality study design for data collection.
- Support validation of new Device integrations.
- Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
- Ensure that all the deliverables are of expected quality standards and meet customer expectations.
- With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
- Support Training of New joiners.
- Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
- Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required.
- Manage the development and implementation of new technology / database revisions.
- Work closely with the programming team for process innovation and automation.
- Be compliant to trainings and eSOP reading.
- Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
- Communication with Line Manager, and other team members across functions should be collaborative.
- Perform other duties as directed by Line Manager.
- Bachelor's Degree Bachelor Pharmacy or equivalent Pref
- 3 -4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref
- English Fluency Spoken and English Advanced
- Advanced computer applications like Microsoft excel, word, Inbox etc Advanced
- Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced