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 Development 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:
The successful candidate will have:
- 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 maintainance of TMFs in accordance with standard procedures, ICH-GCP and EMA guidelines and regulations.
- Application Manager (Zealand Super User) 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.
- Driving eTMF migrations and relevant documentation from initialization to finalization.
- 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.
- 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.
- Experience in eTMF migrations can be beneficial.
- 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 send your cover letter/CV no later than August 7, 2020.
For further information, please contact Director of Clinical Operations, Metabolic Disease & Systems, Christina Sylvest at +45 5060 3890 or CSY@zealandpharma.com.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, development, and commercialization of next generation peptide-based medicines that change the lives of people living with metabolic and gastrointestinal diseases. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s robust pipeline of investigational medicines includes three candidates in late stage development, and one candidate being reviewed for regulatory approval in the United States. Zealand markets V-Go®, an all-in-one basal-bolus insulin delivery option for people with diabetes. License collaborations with Boehringer Ingelheim and Alexion Pharmaceuticals create opportunity for more patients to potentially benefit from Zealand-invented peptide therapeutics. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in New York, Boston, and Marlborough (MA). For more information about Zealand’s business and activities, please visit http://www.zealandpharma.com.