Be our new eTMF Manager
In a biotech company bonding to discover, design and develop innovative peptide-based medicines
We are looking for an eTMF Manager, with experience in eTMF management, user access management, training, and system improvements.
In your daily work, you will work closely together with our Sr System Management Specialist 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 responsibilities within eTMF operations with an independent and collaborative attitude, you are a match for us.
Clinical Oversight and Compliance is a newly established department within Clinical Operations. We are a group of 4 dedicated professionals specializing in sponsor oversight, clinical technologies, processes, and compliance. Our team work as one team and value an informal atmosphere with focus on knowledge sharing and excellence. The position is located at our headquarters in Søborg, reporting to the Head of Clinical Oversight and Compliance.
Responsibilities
- Oversee eTMF System and collaborate with CTAs, QA, IT, Internal Departments, and CROs to ensure compliance and efficiency
- Participate in IT System Oversight bi-yearly meetings
- Provide input for Periodic Reviews (trainings, access, incident tickets, CRs, file plans, deletions, audit trails)
- User access management and maintain the User Access Control Lists for our eTMF applications and conduct quarterly User Access Reviews
- Support in eTMF tickets resolution via Zealand Helpdesk and deliver eTMF System training across all user roles
- Contribute to maintain the eTMF training materials
- Participate in Internal Audits and Inspections
- Participate in eTMF System updates and Join Governance meetings with eTMF vendors on an ad-hoc basis
Candidate profile
- Bachelor’s degree and 3years’ experience with TMF/eTMF management or eTMF System management
- Experience in performing TMF training across an organization, Service Providers and Inspectors
- Experienced collaborator with cross-functional teams including IT, QA, and external service providers
- Enjoys working in changing biotech environment,
- Excellent communication and problem-solving skills
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 April 15, 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
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 presence in the U.S. For more information about Zealand Pharma’s business and activities, please visit www.zealandpharma.com.
