Be the new
Clinical Trial Administrator
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is seeking an experienced Clinical Trial Administrator to the Clinical Operations Department. The department is responsible for setting up, overseeing and directing clinical trials from early development phases to market approval typically with the use of and collaboration with Clinical Research Organizations (CROs).
The department is part of Clinical and Medical Affairs and is composed of a dynamic team with enthusiastic and professional colleagues. We have an open and respectful working environment with great team spirit and high quality mind-set encouraging knowledge sharing and development of people and processes.
We value proactiveness and engagement in order to continue to find better solutions.
The successful candidate will be:
An essential member of the Trial Management team
An active member of the CTA group and proactively plan tasks and continuously evolve processes
Responsible for establishing and overseeing the Trial Master Files (TMFs); overseeing the CRO maintenance of TMFs in accordance with standard procedures, ICH-GCP and EMA guidelines and regulations
Superuser/application manager of the Zealand Pharma eTMF system and involvement in the management of the system, training of users and implementation of any relevant updates
Working in close collaboration with CROs on relevant plans and TMF filing
Performing quality control of the final TMF and ensure final archiving
Responsible for appropriate indexing, uploading and quality control (QC) of relevant documents to the electronic document management system (EDMS) in adherence with guidelines and Zealand Pharma SOPs
Responsible for supporting and advancing the clinical operational procedures in the Department for Clinical Development
Supporting Clinical Trial Managers in the planning and management of Zealand Pharma’s clinical trials from preparation of trial synopsis until reporting.
The successful candidate will have:
Previous experience (at least 3 years) of working as a CTA in the Pharmaceutical Industry
Experience from working in a CRO or from collaborating with CROs will be an advantage
A B.Sc. degree in a relevant field preferably
Thorough experience and interest in management and oversight of TMFs
Interest and experience in management of eTMF system(s)
Ability to work independently and proactively with clinical trials
Knowledge of ICH-GCP and FDA/EMA regulations and guidelines
A quality mind-set with a sense for details
Proficiency in both written and spoken English
Experience with Microsoft Office Package
Team spirit and motivation to work with new challenges.
What we offer
Zealand’s employees are one of the company’s most important assets. We strive to attract, develop and retain the best talents, and to be a company where every employee can thrive.
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 salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities.
To find out more about working at Zealand, visit our careers site and view our company video at:
Please apply no later than November 24, 2019.
For further information, please contact Director, Clinical Operations, Gertrud K. Rasmussen
at +45 5060 3773 or firstname.lastname@example.org
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: 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. Zealand’s portfolio also includes two clinical license collaborations 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
or follow Zealand on LinkedIn or Twitter @ZealandPharma.