Senior Clinical Data Manager (Mandarin)
- Kuala Lumpur, Malaysia
$9.1bn! Novartis has invested that amount in R&D, and we are committed in the clinical development and getting more patients' access for disease treatments globally. We are hiring potential talent to fill in the role for Novartis Global Service Center in Kuala Lumpur to support the China region.
In this role, you are helping Novartis in generating more evidences to support patients' access and treatment benefits across the world, by providing timely and ongoing Data Management deliverable of clinical trial data with respect to cost and quality for all assigned trials within the Clinical Data Management.
Your Responsibilities include, but are not limited to
• Provide professional DM input as required on in-house and outsourced trials to relevant stakeholders. Participate in Clinical Trial Team/Data Review Team meetings as applicable. Input to and review of clinical trial database design including User Acceptance Testing (UAT).
• Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data.
• Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site/data review team, to ensure high quality and timely database locks.
• Review and contribute to preparation of protocols as required to support stakeholders, specifically related to the data management section, visit schema, study design and standards. Responsible for preparation of Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper.
• For studies which have central data monitoring, CDME(Central Data Monitoring Expert) will be responsible for all oversight of the data including DM deliverables. Will drive necessary actions as needed and ensure proper integration of central data monitoring requirements.
• Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock. Drive the same with data collection providers, as required.
• Perform training on data management software and practices or trial specific topics as required. Prepare training materials for data management activities and processes as required.
• 5 or more years' experience in drug development with at least 3 years' experience in Data Management.
• University Science Degree in Life sciences, Pharmacy, nursing or equivalent relevant experience.
• Excellent in the English and Mandarin language skills (written and spoken). A must have to support the China region.
• Has understanding of clinical trial methodology, GCP and medical terminology
• Good computer skills, good organizational with good project management skills.
• Good communication and interpersonal skill. Has good problem solving skills.
• Ability to work well in a team and may coordinate and provide direction on task to other data management team members
About the Novartis Global Service Center in Kuala Lumpur:
The Novartis Global Service Center (NGSC) in Kuala Lumpur delivers a broad variety of services to the Novartis divisions worldwide. Kuala Lumpur is part of a globalized network of five NGSCs, which form a successful network of services minded associates partnering with the Novartis business around the world.
What makes NGSC special?
Attractive office location, flexible time management, strong work/life balance, flexible working hours, truly multinational and dynamic organization, multicultural environment and cross-functional hub location
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're 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 people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's 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
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