Senior Principal Clinical Data Manager (m/w/d)
|Division||Global Drug Development|
|Standort||Holzkirchen (near Munich)|
|Funktionsbereich||Research & Development|
|Art der Stelle||Vollzeit|
8 biosimilars across immunology, oncology and endocrinology are already on the market, Sandoz Biopharmaceuticals has a leading biosimilars pipeline with additional molecules in various stages of development. As Senior Principal Clinical Data Manager you contribute to the future success of our biosimilars development and you are responsible for Data Management relevant aspects related to e.g. eCRF development, data cleaning. In addition, you provide nonclinical expertise to assigned biosimilar program teams and lead the timely planning of the nonclinical development programs.
• Provides Data Management leadership for one or more assigned programs/projects 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 impact the programming team. Ensures consistency of program level standards
• Communicates and negotiates effectively with all other Program level team members. Primary point of contact for DM at the GPT level.
• Maintains awareness of the status of start-up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting led by DO DUs & Sr GHs/GHs.
• Demonstrates an effective application of knowledge across all DM scenarios. Is able to provide solutions to effectively meet timelines
• Manages effective escalation of issues in order to keep stakeholders 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.
• Coaches and mentors associates as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution.
• Develops risk management strategies to prevent data quality issues from derailing projects
• Represents Data Management at cross functional forums, meetings and provides timely feedback to partners
• Understands Health Authority requirements and is able to prepare for and participate in Health Authority inspections and audits as required
What you’ll bring to the role:
• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• Fluent English (oral and written).
• 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
• Ideally 8 years’ experience in Drug Development with at least 5+ years' in Clinical Data Management
• Understanding of project management concepts in order to aid delivery across a program
• Excellent verbal and written skills
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Join us, and help reimagine access to medicine.
Sandoz stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
Auf diese Stelle bewerben Stelle empfehlen Zurück zur Übersicht