Senior Clinical Data Manager

Job Description

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. Lead and support clinical & non-clinical special projects. May deputize for Head of Statistical Sciences Group for US Medical in India and assist in hiring, coaching, training, and mentoring of other Data Management staff.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 membersWhy consider Novartis 799 million. That s how many lives our products touched in 2019. And while we re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people s lives We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks, and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges.Imagine what you could do at Novartis! Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network,

Keyskills :
datamanagement databaseadministration programming customerrelations datavalidation drugsafety dataquality correctiveactions linicalprojectmanagement behavioral