Be our new Senior Oversight Manager, Clinical Oversight & Compliance
Are you ready to make a significant impact within Clinical Oversight and Compliance? Join us as our Senior Oversight Manager, where you'll focus on Sponsor Oversight and Quality Risk Management. In this role, you will perform various oversight activities of our Service Providers and play a key role in developing our BI oversight tool. You'll also continue to advance our Quality Risk Management processes, ensuring that SOPs and procedures are up-to-date.
In your daily work, you will work closely together with our Senior Oversight Manager, Clinical Trial Teams, QA GCP and collaborate both with internal departments and external service providers, including CROs. If this sounds appealing to you, and you are ready to take on a broad area of responsibility within sponsor oversight and quality risk management with an independent yet collaborative approach, you could be a match for us.
Clinical Oversight and Compliance is a department within Clinical Operations. We are a group of 6 dedicated professionals specializing in sponsor oversight, clinical technologies, processes, and compliance. Our team works as one team and values an informal atmosphere with a focus on knowledge sharing and excellence.
Key Responsibilities:
- Continue developing Sponsor Oversight expertise, focusing on both functional and fully outsourced models. Identify key areas for improvement,
- Facilitation of Sponsor oversight set-up and training in procedures,
- Maintain procedures for Sponsor Oversight of clinical trials and programs reflecting best practices and regulatory requirements,
- Perform Sponsor Oversight of Service Providers and coordinate follow-up of oversight outcome with the Service Provider (SP),
- Ensure development, maintenance and execution of Sponsor Oversight Visit plan and perform oversight visits,
- Facilitate eTMF oversight with Clinical Research Associates (CRAs) and eTMF Managers,
- Maintain procedure for Quality Risk Management (QRM) and perform training
- Continue developing Quality Risk Management expertise within Clinical Oversight & Compliance Department,
- Participating in Regulatory inspection readiness, Regulatory inspections and Audits.
Candidate Profile:
- Master’s degree in Life Sciences or a related field,
- Process a minimum of 6 years of experience in Sponsor Oversight and Quality Risk Management within the biotech or pharmaceutical industry,
- Demonstrate in-depth knowledge of clinical trial regulations and guidelines, including ICH-GCP, FDA, and EMA requirements,
- Strong analytical and problem-solving skills, with a strategic mindset, emphasizing experience in risk mitigation and data-driven decision-making,
- Excellent communication and interpersonal skills, with the ability to foster collaboration across departments,
- Detail-oriented with robust project management capabilities.
Bonding to innovate
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.
Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.
We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise.
We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.
The Zealand Pharma 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.
Let’s bond and be bold
We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our 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 https://www.zealandpharma.com/careers/zealand-as-a-workplace/
Interested? Please apply no later than October 19, 2025, or as soon as possible. The applications will be reviewed as they come in.
For further information, please contact Helle Maach-Møller, Head of Clinical Oversight and Compliance on hmaachmoller@zealandpharma.com or +45 5060 3687
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a team in the U.S. For more information about Zealand Pharma’s business and activities, please visit www.zealandpharma.com.
