Data Management Associate II (India)

Data Management Associate II (India)

02 Oct
|
Teva Pharmaceutical
|
India

02 Oct

Teva Pharmaceutical

India

We Are Teva

We’re Teva, a leading cutting-edge biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

How You’ll Spend Your Day
- Perform Lead Data Manager role; oversee/ drive the DM deliverables for the project, communications with the stakeholders, ensuring adherence to timelines
- Proactively coordinate and perform start-up, maintenance and close out activities, as detailed in our SOPs and guidelines
- Lead study setup including but not limited to;
- Review of the study protocol
- Preparation and review of eCRF specifications, Time and Event Schedule, ECS, eCRF Completion Guidelines, DMP, Safety Reconciliation Plan, Manual Listings,



UAT Summary, Change Log documents
- Create and review of the test scripts for the UAT
- Performing UAT for the study
- Performing query management which include, query generation and query resolution
- Perform SAE reconciliation and Lab/Vendor data reconciliation
- Performing manual review of data, Pinnacle 21 and smart listings
- Locking the database as detailed in SOP as per timelines for the statistical review
- Performing post production changes and assessment of impact on database in consultation with the Database Programmer
- Generating metric reports / status reports for the CDM status of the study and informing of any study related issues to relevant stakeholders when required for further action
- Maintain study specific documentation as per in-house standards, procedures & regulatory requirements
- Participation in reviewing and responding to or sponsor audits/ inspection reports
- Proactive

📌 Data Management Associate II (India)
🏢 Teva Pharmaceutical
📍 India

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