Medical and Diagnostic Laboratories

Alentis Therapeutics

51-200

Alentis Therapeutics, the Claudin-1 Company, is on a mission to treat cancer and reverse fibrosis. To this end, we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin-1 and bringing much-needed medicines to patients suffering from solid tumors as well as kidney, liver, and lung fibrosis.
<h2>Tasks</h2>
Manages and executes the clinical trial preparation and conduct. 
Acts as the ambassador of Alentis towards external service providers and partners. 
Supports the Head of Clinical Operations (HCO) and/or Clinical Trial Leader (CTL) in clinical trial management activities.
<ul>
<li>Provide temporary senior-level operational support to strengthen study execution capacity.
</li>
<li>Take ownership of delegated study workstreams and ensure timely delivery in accordance with study timelines, quality expectations, and budget assumptions.
</li>
<li>Support the CTL and/or Head of Clinical Operations in the operational management of assigned clinical trial activities, including but not limited to:
</li>
<li>Contribute to and coordinate the development and approval of study documents as the synopsis, protocol, ICF, study-specific guidelines and plans in accordance with internal SOPs and GCP requirements. 
</li>
<li>Evaluation and selection of service provider, assist in contract preparation. 
</li>
<li>Responsible for service provider oversight and the initial review of service provider / third-party invoices to ensure that work is performed in accordance with the scope of work. 
</li>
<li>Responsible for study start up activities such as initial study risk assessment, review and contribution to the feasibility process incl. countries and investigative sites selection.
</li>
<li>Assist with the development of regulatory documents, coordination of responses to Health Authority and EC/IRB questions. 
</li>
<li>Support the Documentation SMEs with document upload and maintenance within the sponsor eTMF and regular vendor eTMF oversight.
</li>
<li>Oversee monitoring activities. Review monitoring reports and protocol deviations.
</li>
<li>Contribute to the development and update of risk-mitigation plans. Monitor and implement contingencies as required. 
</li>
<li>Ensure set up and maintenance of study reporting tools and tracking systems to oversee and report the study progress to the Management Team.
</li>
<li>Close oversight and management of the recruitment progress and milestone deliverables in accordance with the study timelines.
</li>
<li>Escalate unresolved issues and mitigation options to the CTL and to Alentis Management Team.
</li>
<li>Ensure timely data entry and close oversight of data cleaning activities.
</li>
<li>Proactively address issues, identify, and implement actions to keep study on track in a timely fashion.
</li>
<li>Support/coordinate inspection readiness, audits and CAPA resolution activities to enable satisfactory outcome.
</li>
<li>Ensure overview and adhesions of timelines and budget within the agreed frame.
</li>
<li>Adhere to and maintain training records to demonstrate an appropriate level of compliance with GCP, applicable regulations and SOPs.
</li>
</ul>
<h2>Requirements</h2>
<ul>
<li>Master degree or equivalent/higher university education/degree in life science or healthcare</li>
<li>Senior CTM at least &gt; 6 years of work experience in a fast-paced biotechnology environment and managing studies in rare diseases and/or fibrosis-related indications e.g. liver fibrosis is highly desirable</li>
<li>Demonstrated expertise in global clinical project (e.g. performed worldwide Europe, America, Asia) and risk management</li>
<li>Strong knowledge of current international clinical trial regulations (e.g. EU / US Regulation) with documented experience in ICH-GCP E6 (latest version)</li>
<li>Prior participation in selecting and managing clinical external service providers.</li>
<li>Experience in selecting / managing “non-technical” service providers (e.g. site start-up, monitoring, TMF management) and “technical” service providers (e.g. Data Management, IRT, electronic Source (e.g. ePRO), imaging)</li>
<li>Strong understanding of clinical trial budget</li>
<li>For Senior: Demonstrated experience in executing the entire range of clinical trial activities (e.g. from preparation of synopsis, initiation/launch of trial, execution, closing database and finalizing CSR)</li>
<li>Experience in fibrosis (e.g. liver fibrosis) is an upside</li>
<li>Demonstrated planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently</li>
<li>Strong communication and presentation skills.</li>
<li>Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment.</li>
<li>Ability to collaborate effectively with external partners (including investigator and site staff).</li>
<li>Pro-active attitude, acting with sense-of-urgency and applying an entrepreneurial mindset.</li>
<li>Fluent in spoken and written English (additional languages advantageous).</li>
</ul>
Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. The work location is Allschwil, Switzerland with 2 days home office possibility. Contract duration is 12 months.

Contractor Senior Clinical Trial Manager (12 months)

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