Senior Data Manager

in a biotech company focused on the discovery, design and development of innovative peptide-based medicines

Zealand Pharma A/S (Zealand) is a Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. 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. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence the U.S. as well.

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 2 data managers, 3 statistical programmers and 6 statisticians. We help create and implement clinical development strategies, manage standards, overseeing critical processes 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.

Job Profile

Responsibilities include:

• 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 CRO's: protocols, RFP's, eCRF's, data management plans, data transfer agreements, lab contracts and data validation plans
• Maintain our data management processes while keeping up to date with requirements

Candidate Profile

The successful candidate will have most or all of the below qualifications:

• Master’s 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
• Experience with outsourcing of clinical trial activities
• Solid communication skills both towards colleagues and external collaborators
• Ability to navigate in a small organization where priorities can change and is:
• A strong team-player who works with both the project teams and within the DM team
• Open to other ways of ‘doing things’ 5+ years in experience with quality systems in the pharmaceutical/biotech industry

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.

Zealand DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.

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 employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities. To find out more about working at Zealand, visit www.zealandpharma.com.

Application

Please apply no later than April 6, 2023.

For further information, please contact Kim Mark Knudsen at +45 5060 3780 or KMKnudsen@zealandpharma.com.

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About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.