Website Teva Pharma ltd
Post Name: Data Management Associate II
We Are Teva:
We’re Teva, a leading innovative 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 participation in appropriate project/ functional/ organizational meetings and initiatives
Participates in the review of cross-functional procedures
Continuous improvement of functional processes and procedures to ensure DM is consistently maximizing efficiencies
Provide training to site personnel in person or via electronic meetings
Training and Mentoring of team members in accordance with established functional procedures
To carry out other responsibilities as and when assigned by the management.
Your Qualification and Experience:
Bachelor’s / Master’s degree in Lifesciences, Pharmaceutical Sciences, Biotechnology or related discipline.
5-7 years of relevant Clinical Data Management experience.
