NOVARTIS Senior Clinical Data Manager life science, computer science,
pharmacy, nursing or equivalent relevant degree
Your key responsibilities:
Your responsibilities include, but 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 ensuring consistency of
protocols, project CRFs, clinical databases for all trials within assigned
projects and provide technical feedback to CROs as needed.
• Provide CDM input to study protocols and Study
Specification Worksheets (SSW) for CRO proposal requests; audit/qualify CROs at
India and 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.
• Ensure complete and consistent medical term coding using
appropriate standard dictionaries; ensure consistency of serious adverse event
data across clinical and drug safety databases.
• Monitor clinical data quality and progress of trials
outsourced to international CROs; drive corrective actions as needed; ensure
proper integration of third-party/non-CRF data as applicable. Proactively
identify project threats and resolve issues with clinical trial teams; escalate
to US Biometrics management if necessary and appropriate.
• Ensure up-to-date and accurate tracking of report status
and progress of data management for allocated trials and be proactive to ensure
smooth and successful timely locking of databases. Ensure timely completion of
data management archiving; as necessary, respond to Health Authority/FDA/audit
requests pertaining to project-specific data management issues.
• Provide input, review, and maintenance of local working
practices and standards.
• Contribute to the development of a Data Management
organization through his/her leadership role within the DM Group for US Medical
in India.
Minimum requirements
• University or college degree in life science, computer
science, pharmacy, nursing or equivalent relevant degree
• Two or more years experience in drug development with at
least 2 years experience in Data Management.
• Understanding of clinical trial methodology, GCP and
medical terminology
• Good organizational and project management skills.
Intermediate presentation and problem solving skills
• Good communication and interpersonal skills. Excellent
written and oral English skills
• Ability to work well in a team.May coordinate and provide
direction on task to other data management team members
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