Principal Clinical Data Manager

Job Description

5! The number of projects you will be leading to develop our growing pipeline of Gene Therapy products. We are looking for an experienced professional in the area of drug product development for Gene Therapy-based drug products, with special focus on viral vectors. As a member of Pharmaceutical Development in the Cell and Gene Therapy Development Unit, Technical Development NBEs, you will play a key role in the development of parenteral dosage forms of viral and non-viral vectors, for gene therapy, for preclinical and clinical studies, as well as in the development of market formulations.Your responsibilities:Your responsibilities include, but are not limited to: Provides Data Management leadership for one or more assigned programs or indications. Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e ensuring consistency across data quality plans. Develops an understanding of CDISC or other recognized industry standards and how these impacts the programming team. Ensures consistency of program level standards. Develops risk management strategies to prevent data quality issues from derailing projects. Communicates and negotiates effectively with all other Program level team members. Primary point of contact for DM at the GPT level. Understands Health Authority requirements and is able to prepare for and participate in Health Authority inspections and audits as required. Maintains awareness of the status of start up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Represents Data Management at cross functional forums, meetings and provides timely feedback to partners. Demonstrates an effective application of knowledge across all DM scenarios. Is able to provide solutions to effectively meet timelines. Coaches and mentors associate as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution. Manages effective customer concern of issues in order to keep partners appraised of DM activities and proposed resolutions. Supervises and drives the overall DM timelines across assigned programs. Reviews the Data Management Metrics on the assigned Program.EEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse team s representative of the patients and communities we serve.Minimum requirements Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines. Excellent understanding of clinical trials methodology, GCP and medical terminology. Must be able to anticipate challenges and risks and proactively suggest/implement solutions. Ability to work under pressure demonstrating agility through effective and innovative team leadership. Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external. 8 years experience in Drug Development with at least 5+ years in Clinical Data Management. University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. Fluent English (oral and written).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 whats 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!Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.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: https://talentnetwork.novartis.com/network,

Keyskills :
data managementclinical trialsgene therapyclinical datarisk managementcomputer sciencedrug developmentproduct developmentinterpersonal skillscareer opportunitiesbusiness understandinggcpeeoriskcell