摘要
To partner and support the functional mentors within the community to set up learning networks across all communities within CDAM. Work seamlessly with partner groups. Lead, contribute to and implement initiatives to establish and maintain Novartis Clinical Data Acquisition and Management as best in class in the industry.
About the Role
Major accountabilities:
- Co-ordinate activities of data managers either internally or externally. Make data management decisions and propose strategies at project or disease level.
- May act as a local manager of global associates including providing supervision and advise to these data managers on functional expertise and processes
- Build and maintain effective working relationship with cross-functional teams incl. Trial Management, Trial Monitoring and Statistical Reporting counterparts, able to summarize and discuss status of deliverables and critical Data Management aspects impacting outcomes.
- Comply with company, department and industry standards (e.g. CDISC) and processes, ensuring data management innovations and foster data management solutions, ensure their efficient implementations and knowledge sharing within the project(s) or disease area.
- Maintain up-to-date advanced knowledge of industry software and reporting tools (e.g. Jreview/Spotfire) as well as industry requirements (e.g. CDISC SDTM/ADaM), attend functional meetings and trainings.
- Represent Data Management at audits and in Health Authority (HA) meetings for assigned project(s), or on data management aspects in external conferences or groups (e.g. SCDM).
- Provide authoritative technical and professional recommendations as representative of the data management function at project level or for a major non-clinical initiative. Provide thought leadership level support and guidance.
- Develops risk management strategies to prevent data quality issues from derailing projects. Carries out lessons learned in order to feedback and further enhance the DM processes
- Help with the recruitment of talent, coach and develop data managers. Leads/supports non-clinical special projects and initiatives like process simplification, automation, capability build.
- Provides subject matter expertise to special projects as needed
- Maintain external focus by interacting and influencing industry working groups and organizations
Key Performance Indicators:
- Achieve overall goals as set each year by Global Head, Clinical Data Acquisition and Management (CDAM)
- All assigned project deliverables meet targets for quality, time and productivity in adherence with business standard operating procedures
- No critical audit findings due to Clinical Data Acquisition and Management
- Adequate representation of the Data Management function as Strategic Lead in the cross-functional forums and initiatives.
- Ability and effectiveness as a data management representative on major non-clinical initiatives.
Impact on the organization:
- Management of strategic deliverables impacting quality of study startups, high quality database locks affecting submission to Health Authorities in a timely manner
- Supports recruitment and retention of talent and effective development of staff
- Innovative technical solutions and enhancements, as well as standardization efforts ensuring timely and efficient drug development
Education (minimum/desirable):
- University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Languages:
Fluent English (oral and written).
Experience/Professional requirement:
- 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 stakeholders
- 2+ years as a PDM including co-ordination of large team of internal or external data managers
- Ideally 10+ years’ experience in Drug Development with at least 8 years' in Clinical Data Management Excellent verbal and written skills.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
