Principal Clinical Data Manager

Jul 27, 2021

Job Description

50 Plus global studies will be the magnitude of the function to which you will be partnering as a team member. Within the Biometrics function you will be playing a key role in taking the accountability and delivering studies end to end of Data Management solutions. Will get opportunity to work on varied clinical studies of all phases which includes Interventional, Non- Interventional, Chart review, Observational, Prospective & Retrospective studies across all therapeutic areas.
At Novartis NBS CONEXTS we aim to provide innovative solutions to help Novartis medical and scientific teams re-imagine medicine, Delivering cost effective and scalable competitive solutions through focus on productivity, Building assets and competitive Novartis solutions, enhancing innovation and our unique service offering, Providing leading edge quality and innovation through our expert global workforce.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Serve as Lead Data Manager for multiple projects/trials from multiple franchises and providing professional Data Management input to Clinical Trial Teams (CTTs) and Data Review Teams (DRT) as applicable. Responsible for ensuring consistency of protocols, project CRFs, clinical databases for all trials within assigned projects and provide technical feedback to stakeholders as needed.
• Provide CDM input to study protocols and Study Specification Worksheets (SSW); provide assumptions to create RFP quotes. Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings, and Data Management documents, 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 with data collection providers; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable. For studies, which have central data monitoring, CDME (central data monitoring expert) will be responsible for all oversight of the data including DM deliverables. Will drive necessary actions as needed and ensure proper integration of central data monitoring requirements.
• Proactively identify project threats and resolve issues with clinical trial teams/data review teams; escalate to Data Sciences management if necessary and as appropriate.
• Ensure up-to-date and accurate tracking of report status and progress of data management activities 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 Data Sciences. Participate in clinical & non-clinical special projects. May assist in hiring, coaching, training, and mentoring of other Data Management staff.

Minimum Requirements

• University or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree with ideally 6 or more years’ experience in drug development, with at least 5 years in Data Management activities.
• Experience in managing outsourced studies or working for a CRO.
• Understanding SAS output and introductory level skills with SAS.
• Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding. Project team leadership experience; good organizational and project management skills. Good technical and problem solving skills.
• Ability to work independently, under pressure, demonstrating initiative and flexibility. Attention to detail and quality focused.
• Good interpersonal and communication skills and ability to operate effectively in an international environment. Good negotiation skills.
• Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners.

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Hyderabad, AP
Research & Development
Full Time
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Principal Clinical Data Manager

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