Novartis Senior CDM Job For Life Sciences – Apply Online
Novartis Senior CDM Job For Life Sciences – Apply Online. BSc/MSc Life Science candidates apply online for a Senior Clinical Data Manager position that is available at Novartis. Novartis is hiring msc/bsc candidates, as per the details below in their Research & Development area:
Job Title: Senior Clinical Data Manager
Job ID: 298264BR
Division: Global Drug Development
Business Unit: GDO GDD
Employment Type: Full-time
Your key responsibilities:
Your responsibilities include, however, are not restricted to:
- Provide professional DM input as required on in-house and also outsourced trials to relevant stakeholders. Participate in Clinical Trial Team/Data Review Team meetings as applicable. Input to as well as a review of clinical trial database design consisting of User Acceptance Testing (UAT).
- Responsible for the Validation as well as Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study-specific validation checks and also necessary reports to guarantee high quality and also consistent data. Drive the same with data collection providers, as required.
- Identify errors and inconsistencies; resolve them or initiate their resolution either by means of the field monitor or directly with the investigational site/data review team, to make sure high quality and also timely database locks. Review as well as contribute to prep work of protocols as needed to support stakeholders, specifically related to the data management section, visit schema, study design and standards.
- Responsible for prep work of Case Report Forms (CRFs) as well as CRF completion Guidelines (CCGs), electronic or paper. Drive the same with data collection providers, as needed.
- For studies which have central data monitoring, CDME( central data monitoring ex-pert) will certainly be accountable for all oversight of the data consisting of DM deliverables. Will drive necessary activities as needed as well as make certain proper integration of central data monitoring requirements. Support and also provide leadership for data management staff for allocated trials.
- Freeze and also lock data as appropriate in time for statistical review, blinded interim quality review, interim as well as final database lock. Drive the same with data collection providers, as required.
- Perform training on data management software as well as practices or trial-specific topics as needed. Prepare training materials for data management activities and also procedures as required. Travelling if required as needed.
- University or college degree in life science, computer science, pharmacy, nursing or an equivalent relevant degree with 5 or even more years’ experience in drug development with a minimum of 3 years’ experience in Data Management.
- Outstanding written and oral English skills. Good communication and interpersonal skills.
- Understanding of clinical trial methodology, GCP and medical terms.
- Great organizational and also project management skills.
- Intermediate presentation and also problem-solving skills.
- Ability to work well in a team. May coordinate as well as provide direction on task to various other data management team members.
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