• Principal Clinical Data Manager Jobs in Hyderabad,India

  • Novartis AG

Job Description:

Job ID 274961BR

Position Title Principal Clinical Data Manager

Job Description Your responsibilities
Your responsibilities include, but are not limited to

1 Provides Data Management leadership for one or more assigned programs or indications
2 Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent data management processes and documentation across assigned programs, ie ensuring consistency across data quality plans
3 Develops an understanding of CDISC or other recognized industry standards and how these impact the programming team Ensures consistency of program level standards
4 Communicates and negotiates effectively with all other Program level team members Primary point of contact for DM at the GPT level
5 Maintains awareness of the status of start up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources
6 Demonstrates an effective application of knowledge across all DM scenarios Is able to provide solutions to effectively meet timelines
7 Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions
8 Supervises and drives the overall DM timelines across assigned programs Reviews the Data Management Metrics on the assigned Program
9 Coaches and mentors associates as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution
10 Develops risk management strategies to prevent data quality issues from derailing projects
11 Represents Data Management at cross functional forums, meetings and provides timely feedback to partners
12 Understands Health Authority requirements and is able to prepare for and participate in Health Authority inspections and audits as required

Minimum requirements University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree Fluent English (oral and written)
1 Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines
2 Excellent understanding of clinical trials methodology, GCP and medical terminology
3 Must be able to anticipate challenges and risks and proactively suggest/implement solutions
4 Ability to work under pressure demonstrating agility through effective and innovative team leadership
5 Excellent interpersonal skills and proven ability to operate effectively in a global environment Ability to influence and communicate across functions and to external stakeholders
6 Ideally 8 years experience in Drug Development with at least 5 years in Clinical Data Management
7 Understanding of project management concepts in order to aid delivery across a program 8 Excellent verbal and written skills

Why consider Novartis
750 million Thats how many lives our products touch And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this how can we continue to improve and extend even more peoples lives

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment Where youre given opportunities to explore the power of digital and data Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges

We are Novartis Join us and help us reimagine medicine

Division Global Drug Development

Business Unit GDO GDD

Location India

Site Hyderabad, AP

Company/Legal Entity Nov Hltcr Shared Services Ind

Functional Area Research & Development

Job Type Full Time

Employment Type Regular

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 15th Mar 2020

Key Skills:

Company Profile:

Novartis AGarfix

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