Our team is dedicated to the preclinical and clinical development of novel pharmacotherapies to treat disorders of the inner ear with high unmet medical need. Because our employees are the key to our success, we carefully select each new member of the team. We seek colleagues who perform their work with knowledge and dedication, who value integrity and who take initiative both within a team and individually.
Does finding a new job in Berlin, the vibrant capital of Germany, sounds like the perfect next step for you? Are you enthusiastic about making a difference in the lives of people with acute hearing disorders? Would you like to become part of an energetic team of inspired and highly skilled professionals? Then we invite you to explore AudioCure´s current job positions.
We are currently recruiting. Please see the link below for your opportunity to join the AudioCure team:
(Senior) Clinical Project Manager
Position Overview and Responsibilities:
Your focus will be on the preparation and execution of AudioCure’s Phase I and Phase II clinical trials in the audiology field. You will work in close collaboration within our team with international CROs and regulatory agencies to ensure that our clinical program is well designed and conducted to adhere to milestones and timelines. Using your excellent planning and organization skills, you will work across diverse projects and indications to advance AudioCure’s drug development.
- A degree in a drug discovery-relevant subject (e.g. biology, biochemistry, medicine, pharmacology, chemistry).
- Several years of hands-on experience in managing clinical trials, particularly multicentre and early stage (First-in-Human, Phase I, Phase II), to a successful conclusion.
- Experienced in compiling and reviewing regulatory and clinical trial documents (e.g. IB, CSP, CRF, SAP, TFL, CSR, TMF).
- In-depth knowledge of ICH-GCP.
- High level of organization to ensure effective management of complex projects, multiple tasks and problem solving.
- Experienced in selection, building productive relationships with and management of CROs and other vendors.
- Development and maintenance of timelines, resource planning and budgets.
- Excellent communication skills.
- Fluent or business German and English (written and spoken).
Preference will be given to candidates who additionally have:
- Experience in pharmaceutical regulatory processes and agency requirements.
- Extensive relevant post-doctoral experience in academia and/or industry.
- High level of organization as well as time management skills to ensure adherence to timelines.
- Experience in Quality Management and SOP setup and review.
Previous job titles might include:
- Clinical Trial Manager (CTM)
- Clinical Study Manager (CSM)
- Clinical Project Manager (CPM)
- Associate Clinical Trial Manager
- Lead Clinical Research Associate (Lead CRA)
If you wish to be considered for this position, please send your cover letter and resumé by 31st May 2019 to: email@example.com