Senior Clinical Data Scientist
Location
Secunderabad | India
Job description
About The Role
Senior Clinical Data Scientist
Location – Hyderabad Hybrid
About the Role: Provide timely and professional ongoing management of Data Management deliverables and of clinical trial data with respect to cost, quality and timelines for all assigned trials within Clinical Data Management. Ensure consistently high quality data available for analysis and reporting.
Key Responsibilities:
- Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed. Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.
- Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards
- Performs DM activities for start up of a study including preparing the eCRF, CCG's where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT). Manage local lab set up for the Clinical Database as applicable
- Performs DM hands on activities during the course of the study.Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM).
- Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation.Supports and assists Junior staff for assigned trials
- Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner.Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
- Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).Ensures adherence to GCP, DM standards, SOPs/WPS and process guidelines
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements Essential Requirements:
- University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
- Ability to work under pressure demonstrating agility through effective and innovative team leadership.
- Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders.
Desirable Requirement:
- Excellent problem solving skills.
- Ideally 4 years' experience in Drug Development with at least 3 years' in Clinical Data Management.
- Excellent verbal and written skills.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Division Development
Business Unit GCO GDD
Work Location Hyderabad, AP
Company/Legal Entity Nov Hltcr Shared Services Ind
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Shift Work No
Early Talent No
Job tags
Salary