Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need.
Santhera has an exclusive license for all indications worldwide to vamorolone, a first-in-class dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with DMD as an alternative to standard corticosteroids. The clinical stage pipeline also includes lonodelestat to treat cystic fibrosis (CF) and other neutrophilic pulmonary diseases as well as an exploratory gene therapy approach targeting congenital muscular dystrophies. Santhera out-licensed rights to its first approved product, Raxone® (idebenone), outside North America and France for the treatment of Leber's hereditary optic neuropathy (LHON) to Chiesi Group.
For further information, please visit the company's website www.santhera.com
Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as
Scope of Work
The Clinical Trial Assistant assists the Clinical Operations team in activities across clinical studies. She/he supports the Clinical Trial Documentation Manager in the set-up, maintenance, documentation and archive of Trial Master Files (TMFs)/e-TMFs.
The role reports to the Clinical Operations Team & Trial Leader.
The core responsibilities are:
- Logistic and administrative support to the Clinical Operations team across the various studies including planning and preparation of investigator and other meetings
- Optimization & maintenance of electronic filing of study and general clinical operations documents including filing of study documents in TMFs/e-TMFs and assistance to archive Trial Master Files
- Creation and maintenance of tracking tools for key study activities
- Quality control of incoming and assembled documents ensuring coding in accordance with Table of Content
- Assemble and dispatch Investigator Site Files
Required background and experience:
- Bachelor or equivalent degree in life science and/or degree in nursing or equivalent
- Basic medical and business knowledge as well as of essential documents of a Trial Master File according to ICH-GCP and the clinical trial process
- Basic experience in clinical trial documentation and document management including filing and maintenance of TMF/e-TMF
- Basic experience in clinical development
- Advanced computer skills in current programs (i.e. MS Office, tracking systems)
- Fluency in English (any other language is a plus)
- Well organized and structured work style ensuring accurate work results with a pro-active attitude
- Detail oriented and reliable in execution of daily tasks
- Ability to work independently in a fast-paced environment with a sense of urgency
- Strong team-player with good communication and interpersonal skills
- High level of perseverance and energy
If you are attracted by this exciting opportunity and the prospects of joining a motivated international team operating on a global level, please send your CV and motivation letter mentioning the position “Clinical Trial Assistant” as the subjectby email to: firstname.lastname@example.org