Clinical trial senior specialist

Acino part Arcera  is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

We are constantly expanding our market position and therefore, we are looking for a dedicated and motivated person to strengthen our Team. 

 Requirements to candidates:

• Past experience as Clinical Trial manager, preferably also in bioequivalence studies
• Experience in due diligence of clinical parts of dossier and gap analysis
• Experience in communication with CROs, Health authorities, partners
• Exceptional knowledge in ICH and GCP
• Used to work in matrix environment
• Proactive, responsible, accountable, thinking out of the box, problem-solving mindset

 Main responsibilities:

• Acting as Clinical Trial manager in current projects
• Participate in due diligence of partner dossiers
• Response to clinical questions from Authorities
• Participate in SOP revisions
• Regulatory intelligence reporting on alerts related to clinical trials
• Hands on work in Clinical trial data bases and TMF maintenance
• Coordination of Monitoring of studies and study insurance

Specific knowledge and skills required:

 Exceptional knowledge in ICH and GCP

What we Offer:

• EMPLOYMENT ON THE TEMPORARY CONTRACT  due to maternity leave of permanent employee.
• International experience and professional growth
• Working in a friendly, dynamic, supportive and diverse environment