Senior Clinical Data Manager (d/f/m) limited contract
- Holzkirchen, Germany
limited until April 2022
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 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.
Your responsibilities include, but not limited to:
• Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed.
• Provides feedback to ensure well written protocols and amendments.
• Disseminates study-level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
• Responsible for leading study start-up activities such as preparing the electronic Case Report Forms (eCRFs), Case Report Form Completion Guidelines (CCGs), DHPs, DRPs and performing User Acceptance Testing (UAT) (if required)
• Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation
• Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
• Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks)
• Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner
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)
• 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, 4 years' experience in Drug Development with at least 3+ years' in Clinical Data Management with Medidata RAVE experience.
• 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.
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, 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.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
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
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