Novartis CDM Job Opening – Life Sciences Apply Online
Novartis CDM Job Opening – Life Sciences Apply Online. Life Science candidates apply online for a Senior Clinical Data Manager position that is available at Novartis. Novartis is hiring bsc/msc candidates, as per the details below in their Research & Development area:
Job Title: Senior Clinical Data Manager
Job ID: 291554BR
Location: Hyderabad, AP
Division: NBS
Business Unit: PLS NBS
Employment Type: Full-time
Job Description:
Your key responsibilities:
Your obligations consist of, however, are not limited to:
- Serve as Project Data Manager for multiple projects/trials from multiple business units (BUs) and providing professional Data Management input to Clinical Trial Teams (CTTs). Responsible for guaranteeing consistency of protocols, project CRFs, clinical databases for all trials within assigned projects and also provide technical feedback to CROs as needed.
- Provide CDM input to study protocols and also Study Specification Worksheets (SSW) for CRO proposal requests; audit/qualify CROs at India and also provide input on CRO selection. Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings, and Validation and Analysis Plans (VAPs) as appropriate.
- Guarantee full and regular medical term coding using appropriate standard dictionaries; ensure consistency of serious adverse event data across clinical and also drug safety databases.
- Monitor clinical data quality and progress of trials outsourced to international CROs; drive corrective actions as needed; guarantee proper integration of third-party/non-CRF data as applicable. Proactively identify project threats and also resolve issues with clinical trial teams; escalate to US Biometrics management if necessary and also appropriate.
- Ensure up-to-date and precise tracking of report status and progress of data management for allocated trials and also be proactive to guarantee smooth and also successful timely locking of databases. Ensure timely completion of data management archiving; as necessary, respond to Health Authority/FDA/audit requests concerning project-specific data management issues.
- Provide input, review, and also maintenance of local working practices and standards.
- Add to the development of a Data Management organization with his/her leadership role within the DM Group for US Medical in India.
- Lead and also support clinical & non-clinical special projects. May deputize for Head of Statistical Sciences Group for US Medical in India and also aid in hiring, coaching, training, and mentoring of various other Data Management staff.
Minimum requirements:
- University or college degree in life science, computer science, pharmacy, nursing or comparable relevant degree.
- Two or even more years experience in drug development with at the very least 2 years experience in Data Management.
- Understanding of clinical trial methodology, GCP and medical terminology.
- Good organizational and also project management skills. Intermediate presentation and also problem-solving skills.
- Excellent communication and also interpersonal skills. Outstanding written and oral English skills.
- Capability to work well in a team.May coordinate and also provide direction on task to other data management team members.
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