Be the new
Senior Clinical Trial Manager
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a fast-growing, fully integrated Copenhagen-based biotechnology company with a highly attractive pipeline. With one product on the market, one candidate in registration and six candidates in the clinical pipeline, Zealand is a unique success story in Danish biotech. 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. In addition to the Søborg Headquarters, Zealand is also located in the United States in Boston (MA), Marlborough (MA), and New York (NY).
- Would you like to conduct clinical trials in collaboration with skilled and passionate colleagues?
- Do you thrive in an environment where you can make a difference?
- Are you driven by boldness and ambitious timelines as well as the processes to ensure compliance with guidelines?
- Would you like to become a “Zealander”?
We are seeking an experienced Clinical Trial Manager to join the Clinical Operations Department. Our department consists of 16 engaged and professional colleagues. We work as one team and value an informal atmosphere with focus on knowledge sharing and excellence. We are responsible for driving forward the clinical project portfolio by setting up, overseeing and reporting clinical trials in collaboration with CROs. Together with your Zealand Pharma colleagues and CRO team, you will be responsible for delivering well conducted clinical trials within agreed timelines, quality, and budget.
As a Senior Clinical Trial Manager, you will be responsible for:
The successful candidate will have most or all of the below qualifications:
- Designing, planning, conducting and reporting of local and global clinical trials
- Leading the clinical trial team - ensuring good collaboration and communication within the team
- Securing a successful trial conduct and trial deliverables
- Leading the development and internal approval of trial protocols
- Setting up trial oversight plans and all relevant tools to ensure continuous trial oversight
- In collaboration with the outsourcing manager, driving the selection of CROs and vendors according to trial needs and requirements
- Overseeing CRO performance continuously during the trials
- Ensuring a successful collaboration with CROs
- Implementing risk assessment and quality risk management of the clinical trials
- Building and maintaining good relationships with clinical trial sites
- Providing input to the clinical development plans and regulatory authority interactions when relevant
- Actively contributing to development of SOPs and clinical operational processes to ensure continuous compliance with new and current guidelines.
What we offer
We have a company culture, which is driven by innovation, mutual respect and excellence. Our work environment is characterized by an informal atmosphere with room for individual contribution and development, and where our employees are encouraged to take initiative and are close to the decision processes.
- A passion for clinical trials and the process required for a successful outcome
- A dynamic team player attitude, with eyes set on the best way forward
- A degree within life-sciences
- A minimum of 5 years relevant clinical trial execution experience
- Strong project management skills
- Experience from collaborating with CROs or working in a CRO
- Solid knowledge and experience within GCP, ICH and FDA/EMA regulations
- Proficiency in written and spoken English
- Strong communication skills and the ability to inspire people around you
- A quality mind-set and a strong knowledge and interest in best practices and procedures
- Ability to juggle with multiple tasks and able to prioritize in a busy work environment
We focus on mutual respect, cross functional teamwork, high work-ethics, engagement, and fun.
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.
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.
We offer a combined compensation package which includes a base salary, pension, bonus, and an attractive warrant 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 our careers site and view our company video at:
Please apply no later than February 19, 2021.
For further information, please contact Christina Sylvest
at +45 5060 3890 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. 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.