Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.
Post : Statistician II
Job Description
• 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
• 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 Assistant Manager/Manager/Senior Manager – CDM 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/ departmental/ organizational meetings and initiatives
• Participates in the review of cross-functional department procedures
• Continuous improvement of departmental 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 departmental procedures
• To carry out other responsibilities as and when assigned by the management
Candidate Profile
Qualification : B.Tech, B.Pharm
Experience : 6 -10 Years of End to End CDM
Additional Information
Experience : 6 -10 Years
Qualification : B.Tech, B.Pharm
Location : Bangalore
Industry Type : Pharma
End Date : 10th September, 2023
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