Clinical Trial Manager

Alentis Therapeutics the Claudin1 Company is on a mission to treat cancer and reverse fibrosis. To this end we are rapidly advancing a clinical pipeline of antiClaudin1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin1 and bringing muchneeded medicines to patients suffering from solid tumors as well as kidney liver and lung fibrosis.

Tasks

• Contribute to and coordinate the development and approval of study documents such as the protocol ICF studyspecific guidelines and plans in accordance with internal SOPs and GCP requirements.
• Assist with the development of regulatory documents coordination of responses to Health Authority and EC/IRB questions.
• Oversee forecasting of IMP and study material supplies.
• Review and contribute to the selection of countries and investigative sites.
• Contribute to vendor evaluation and selection assist in contract preparation.
• Responsible for vendor oversight and the initial review of CRO and other thirdparty study vendor invoices to ensure that work is performed in accordance with the scope of work.
• Plan and support the organization of Investigator meetings CRA and site staff training events & review related material.
• Ensure overview and adhesions of timelines and budget within the agreed frame.
• Ensure set up and maintenance of study reporting tools and tracking systems to oversee and report the study progress to the Management Team.
• Contribute to the develop of recruitment and riskmitigation plans. Monitor and implement contingencies as required. Escalate unresolved issues and mitigation options to the Management Team.
• Oversee monitoring activities. Review monitoring reports and protocol deviations.
• Ensure timely data entry and close oversight of data cleaning activities.
• Proactively address issues identify and implement actions to keep study on track in a timely fashion.
• Support/coordinate inspection readiness audits and CAPA resolution activities to enable satisfactory outcome.
• Ensure that proper study documentation is maintained and archived in the sponsor and CRO (e)TMF.
• May contribute to the development and improvement of clinical SOPsAdhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP applicable regulations and SOPs.

Requirements

• Master degree or equivalent university education/degree in life science or healthcare.
• >3 years of experience in Oncology clinical study management is required ideally in a biopharmaceutical industry or biotech setup. Early clinical trials experience is an asset.
• Demonstrated expertise in global clinical project and risk management.
• Extensive and documented experience in ICH GCP E6 (latest version).
• Used to work in a multidisciplinary setting strong cooperative team player ability to be flexible and adapt to a changing environment.
• Good planning prioritization problem solving and organizational skills; strong customerorientation used to work independently.
• Experience in oncology or fibrosis is an upside.
• Advanced knowledge of current clinical trial regulations (e.g. ICH GCP).
• Strong communication and presentation skills.
• Fluent in English (additional languages advantageous).
• Demonstrated experience in executing the entire range of clinical trial activities (from preparation initiation to execution and closing).
• Prior experience in selecting and managing external service providers and vendors.
• Good understanding of clinical trial budget.
• Proactive attitude acting with senseofurgency and applying an entrepreneurial mindset.
• Ability to collaborate effectively with the study team crossfunctional team members and external partners (including investigator and site staff).

Benefits

We offer a competitive salary and opportunities for career growth and development. If you are a highly motivated and skilled scientist looking to join a dynamic and innovative team please submit your CV.

Work permit: Swiss or EC national with appropriate work permit.