Join a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a fast-growing, fully integrated Copenhagen-based biotechnology company with a highly attractive pipeline. With one product on the market, one candidate in registration and six candidates in the clinical pipeline, Zealand is a unique success story in Danish biotech. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs. In addition to the Søborg Headquarters, Zealand is also located in the United States in Boston (MA), Marlborough (MA), and New York (NY).
We are looking for a Senior Data Manager who can help develop the data management function across all development projects at Zealand Pharma. You will be part of the Biometrics Department, currently consisting of 1 data manager, 1 statistical programmer and 4 statisticians. We help create and implement clinical development strategies, manage standards, and provide expert sparring to external partners.
In your present job, you are an expert within your area and acting as a data management project leader. Now you have an ambition to extend your competencies and involvement.
Responsibilities includes helping us to:
- Develop, administer and drive alignment of our data standards and data collection requirements across all clinical trials by putting CDISC into practice
- Define and lead data management activities within our clinical trials and submission teams through external partners and CROs
- Develop and implement new ideas, focusing on efficiency gains within and across projects
- Review deliverables from CROs: SDTM’s data packages, eCRFs, data management plans and data validation plans
- Maintain our data management processes while keeping up to date with requirements
The successful candidate will have most or all of the below qualifications:
- Masters degree in natural sciences or similar
- At least 5 years of clinical data management experience in the pharmaceutical/biotech industry
- Hands-on experience with submissions and regulatory inspections
- CDISC SDTM/ADaM practical involvement including define.xml and reviewers guides
- Experience with outsourcing of clinical trial activities
- Solid communication skills both towards colleagues and external collaborators
- Ablity to navigate in a small organization where priorities can change fast
- Open to other ways of ‘doing things’
What we offer
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Our work environment is characterized by strong cross functional team-work, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined compensation package which includes a base salary, pension, bonus, and an attractive warrant program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities.