Job for Clinical Data Manager at Novartis | Degree in Life science, Pharmacy
Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Lead - Clinical Data Manager
1. 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.
2. Responsible for ensuring consistency of protocols, project CRFs, clinical databases for all trials within assigned projects and provide technical feedback to CROs as needed.
3. Provide CDM input to study protocols and Study Specification Worksheets (SSW) for CRO proposal requests; provide input on CRO selection.
4. Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings, and Validation and Analysis Plans (VAPs) as appropriate.
5. Ensure complete and consistent medical term coding using appropriate standard dictionaries; ensure consistency of serious adverse event data across clinical and drug safety databases.
6. 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.
7. Proactively identify project threats and resolve issues with clinical trial teams; escalate to CDS management if necessary and appropriate. 8. 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.
9. Ensure timely completion of data management archiving; as necessary; respond to Health Authority/FDA/audit requests pertaining to project-specific data management issues.
10. Provide input, review, and maintenance of local working practices and standards.
11. Participate in the development of a Data Management organization through his/her leadership role within the DM Group for CDS.
12. Participate in clinical & non-clinical special projects. May assist in hiring, coaching, training, and mentoring of other Data Management staff.
Candidate Profile :
Bachelor’s degree in Life Sciences, Computer Science, Medical Informatics or equivalent. Preferred Post-graduate university or college degree in Life Sciences, Computer Science, Medical Informatics Fluent English (oral and written).
1. Significant relevant experience and knowledge in the Pharmaceutical or Device Industry including experience in CDISC standardization, ICH and other Health Authority guidelines.
2. At least 7 years of experience in global drug development, within the pharmaceutical or device industry
3. A demonstrated leader and expert in Data Standards
4. Strong leadership skills including leading without direct authority, operations, and innovation globally in complex matrix structures and business models.
5. Superior interpersonal and communication skills. Builds positive departmental and inter-departmental relationships.
6. Proven ability to proactively identify issues, recommend and implement solutions
Experience: 4 or more
Qualification: Degree in Life Science, pharmacy, nursing
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Research & Development
Job ID: 182442BR
Last Date: 15th July, 2017
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