Principal Clinical Data Manager

Principal Clinical Data Manager
Company:

Novartis Ag


Principal Clinical Data Manager

Details of the offer

Job ID 296807BR

Position Title Principal Clinical Data Manager

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.
Lead functional activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
Co-ordinate activities of Data Managers either internally or externally. Make data management decisions and propose strategies at study or project level.
Ensure application of consistent data management processes, influence increased standardization and documentation across assigned project/programs
Comply with company, department and industry standards and processes. Provide and implement data management solutions; ensure knowledge sharing.
Leads process and training deliverables within multiple platforms, franchises or therapeutic areas Develops strategies to ensure effective training and knowledge retention.
Progresses DO towards complete, compliant, agile and simple end to end processes and effective training (Protocol/Measure through Analysis and Reporting). Drives towards agreed deliverables, proactively addressing potential issues before they become problematic
Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical data management aspects.
Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response.
Manages and measures quality -Coordinates exception requests, deviations and corrective/preventative action plans Ensure timely and quality development/ validation of CRFs and edit specifications for assigned studies/programs Responsible for quality control and audit readiness of all assigned data management deliverables as well as accuracy and reliability of the clinical database.
Coaches and mentors associates as required -Act as subject matter expert (SME) or, as assigned, lead process improvement/non -clinical project initiatives. Develops risk management strategies to prevent data quality/coding issues from derailing projects
Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions
Represent Data Management at audits and in Health Authority (HA) meetings for assigned project(s)
Provide Functional/technical Coding leadership for Therapeutic Area/Franchisee having multiple trials or mega trials in the role of Lead Coder and ensures that Clinical Coding is performed at a consistently high standard. Serves as the primary program/therapeutic area lead ensuring timely and quality deliverables by establishing strong working relationships with study teams & functional lines. Lead independently or participate in improvement initiatives and/or non-clinical projects.

Minimum requirements University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. Ideally 8 years experience in Drug Development with at least 5 years' in Clinical Data Management
Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines
Excellent understanding of clinical trials methodology, GCP and medical terminology
Must be able to anticipate challenges and risks and proactively suggest/implement solutions. 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
Understanding of project management concepts in order to aid delivery across a program 8. Excellent verbal and written skills
Why consider Novartis?
799 million. Thats how many lives our products touched in 2019. 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.

Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Shift Work No


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