Sr. Clinical Data Manager Job in Novartis
Sr. Clinical Data Manager
Novartis
4+ weeks ago
- Hyderabad, Telangana
- Not Disclosed
- Full-time
- Permanent
Job Summary
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
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
Excellent problem solving skills
Qualification : Bachelors degree in life science, computer science, pharmacy, nursing
Job Description
Your responsibilities include, but are not limited to: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
Minimum requirements
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree with Ideally 5 years experience in Drug Development with at least 4 years in Clinical Data ManagementAbility 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
Excellent problem solving skills
Qualification : Bachelors degree in life science, computer science, pharmacy, nursing
Experience Required :
4 to 5 Years
Vacancy :
2 - 4 Hires
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