Senior Clinical Data Manager(Sr.CDM)
- Employer
- Novartis
- Location
- Hyderabad, India
- Salary
- Competitive
- Closing date
- May 30, 2023
View more
- Sector
- Pharmaceutical, Clinical Manager/ Director
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Professional
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Job Description
500 studies across multiple therapeutic areas. This is the exposure and scale our Data Management group has. We are on our journey to Reimagine medicine with Data and Digital and our team is focused on delivering data which is fit for purpose.
Innovation at scale is one of the strategic pillars for us as a Clinical Data Management team and you will have an opportunity to apply your skills to experiment and innovate ways to transform the Clinical Data Management process in Drug Development.
We are looking for individuals with end to end experience in clinical data management. You will play a key role in providing leadership to various teams and developing cross-functional data cleaning strategies.
Your key responsibilities:
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
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
• Ideally 4 years’ experience in Drug Development with at least 3 years' in Clinical Data Management
• 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
• Excellent verbal and written skills
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & 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: https://talentnetwork.novartis.com/network
500 studies across multiple therapeutic areas. This is the exposure and scale our Data Management group has. We are on our journey to Reimagine medicine with Data and Digital and our team is focused on delivering data which is fit for purpose.
Innovation at scale is one of the strategic pillars for us as a Clinical Data Management team and you will have an opportunity to apply your skills to experiment and innovate ways to transform the Clinical Data Management process in Drug Development.
We are looking for individuals with end to end experience in clinical data management. You will play a key role in providing leadership to various teams and developing cross-functional data cleaning strategies.
Your key responsibilities:
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
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
• Ideally 4 years’ experience in Drug Development with at least 3 years' in Clinical Data Management
• 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
• Excellent verbal and written skills
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & 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: https://talentnetwork.novartis.com/network
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