Job Description for Clinical Data Manger at Novartis:
Ensure quality and timely clinical data delivery for multiple CPO local studies and projects outsourced to international Contract Research Organizations (CROs) and establish appropriate application of data standards, monitor CRO progress, and perform quality assurance review of key clinical data management (CDM) deliverables. 
- Serve as Project Data Manager for multiple projects/trials from 1-2 business units (BUs) and providing professional Data Management input to Clinical Trial Teams (CTTs) and CPOs as needed.
- 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; 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 CDS 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.
- Participate in the development of a Data Management organization through his/her leadership role within the DM Group for CDS.
- Participate in clinical & non-clinical special projects. May assist in hiring, coaching, training, and mentoring of other Data Management staff.
Exp: 8 – 12 yrs
About Novartis:
Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.
