Clinical Trial Manager/leader

vor 2 Wochen

Allschwil, Schweiz Alentis Therapeutics AG Vollzeit

**Job Profile**:
Alentis' lead therapeutic program, ALE.F02, has finished recruitment into a Ph1a study in healthy volunteers and is currently being developed for the treatment of advanced fibrotic diseases. ALE.C04 will enter clinical studies in oncology in 2023.

**Key words**:
Clinical trial documents authoring; Lead clinical trial team; CROs management; Operational excellence; Clinical trial data review

**Responsibilities**:

- Acts as the ambassador of Alentis towards investigators, external vendors and partners
- Develop effective working relationship with key investigators in assigned therapeutic area to optimize trial execution and scientific interaction
- Plan and support the organization of Investigator meetings and site staff training events
- Optimize trial-related working processes to facilitate collaborations with partners
- Contribute to trial/disease-related advisory boards
- Guide external vendors (including but not limited to CRO) to demonstrate high-quality interactions with investigators/sites.
- Manage and execute the clinical trial preparation and conduct:

- Lead the development of study documents such as the synopsis, protocol, ICF, study-specific guidelines and plans in accordance with internal SOPs and GCP requirements
- Contribute to the development of regulatory documents (e.g. Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents), coordination of responses to Health Authority and EC/IRB questions
- Lead and matrix manage the trial team (either partially or fully outsourced to CRO) to ensure all trial deliverables are met according to timelines, budget, and resource requirements, the activities include but not limited to:

- 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 third-party study vendor invoices to ensure that work is performed in accordance with the scope of work
- 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 risk-mitigation 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
- In collaboration with Alentis medical and clinical pharmacology responsible contribute to the clinical trial data ongoing clinical review, final analysis and interpretation including the development of dose finding reports, clinical trial reports, publications and internal/external presentations
- Contribute to the development and improvement of clinical SOPs
- Implement best practices and standards for trial management with the goal of operational excellence
- Adhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP, applicable regulations and SOPs.

**Qualifications, Experience and Competencies**
- Advanced degree or equivalent university education/degree in life science or healthcare
- 3 years of experience in clinical research, ideally in a biopharmaceutical industry or biotech setup. Early clinical trials experience is an asset.
- Hands-on experience in patient data review, cleaning, analysis and interpretation is recommended
- Experience with data visualization tool (e.g. Spotfire) is recommended
- Demonstrated expertise in global clinical project and risk management
- 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 customer-orientation, 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 spoken and written 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
- Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staf

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