Contractor Senior Clinical Trial Manager (12 months)

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.

Tasks

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.

• Provide temporary senior-level operational support to strengthen study execution capacity.

• Take ownership of delegated study workstreams and ensure timely delivery in accordance with study timelines, quality expectations, and budget assumptions.

• Support the CTL and/or Head of Clinical Operations in the operational management of assigned clinical trial activities, including but not limited to:

• 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.

• Evaluation and selection of service provider, assist in contract preparation.

• 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.

• 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.

• Assist with the development of regulatory documents, coordination of responses to Health Authority and EC/IRB questions.

• Support the Documentation SMEs with document upload and maintenance within the sponsor eTMF and regular vendor eTMF oversight.

• Oversee monitoring activities. Review monitoring reports and protocol deviations.

• Contribute to the development and update of risk-mitigation plans. Monitor and implement contingencies as required.

• Ensure set up and maintenance of study reporting tools and tracking systems to oversee and report the study progress to the Management Team.

• Close oversight and management of the recruitment progress and milestone deliverables in accordance with the study timelines.

• Escalate unresolved issues and mitigation options to the CTL and to Alentis Management Team.

• 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 overview and adhesions of timelines and budget within the agreed frame.

• Adhere to and maintain training records to demonstrate an appropriate level of compliance with GCP, applicable regulations and SOPs.

Requirements

• Master degree or equivalent/higher university education/degree in life science or healthcare
• Senior CTM at least > 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
• Demonstrated expertise in global clinical project (e.g. performed worldwide Europe, America, Asia) and risk management
• Strong knowledge of current international clinical trial regulations (e.g. EU / US Regulation) with documented experience in ICH-GCP E6 (latest version)
• Prior participation in selecting and managing clinical external service providers.
• 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)
• Strong understanding of clinical trial budget
• 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)
• Experience in fibrosis (e.g. liver fibrosis) is an upside
• Demonstrated planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently
• Strong communication and presentation skills.
• Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment.
• Ability to collaborate effectively with external partners (including investigator and site staff).
• Pro-active attitude, acting with sense-of-urgency and applying an entrepreneurial mindset.
• Fluent in spoken and written English (additional languages advantageous).

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.

Alentis is the leading biotech company developing anti-Claudin-1 therapies. Claudin-1 is an extraordinary target that plays a key role in many solid tumors and fibrosis. We are committed to unlocking the broad potential of Claudin-1 and bringing much-needed new medicines to patients.