Experience

1MED SA

• Switzerland
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Clinical Project Manager

  • Sep 2021 - Present



Medical Trials Analysis

• Switzerland
• Research Services
• 1 - 100 Employee

• Project Manager

  • Jan 2020 - Aug 2021



APR Applied Pharma Research s.a.

• Switzerland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Clinical Affairs Manager

  • Jan 2018 - Dec 2019

  Clinical Trials: Post-Market Clinical Follow-up studies, Interventional Studies with class III medical device intended for wound management (debridement, irrigation, cleansing and moistening of acute and chronic wounds).Main activities: -Draft clinical reports and contribute in drafting of clinical documentation (e.g. protocol, CRF and PIS-ICF).-Control and medical review of clinical data.-Contribution in creating database for Data Management activities.-Review of clinical statistical data. .-Draft Post Market Clinical Follow-up Plans and Clinical Evaluation Reports in accordance with Annex X of Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EEC and based on MEDDEV 2.7.1:2016.-Perform monitoring visits-Draft SOPs related to clinical activities.-Deliverables should meet quality standards and meet company timelines.



Industrie Biomediche Insubri SA

• Switzerland
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Manager Clinical Operations

  • Jan 2017 - Dec 2017

  Post-Market Clinical Follow-up studies, Observational Studies with class III implantable medical device intended for filling bone defects and bone augmentation .Main activities : Responsible of the following: -Coordinate clinical activities associated with study start-up and management of clinical studies-Set-up all the study documentation for clinical studies (writing of study protocols, study specific guidelines, subject information & informed consent form, lnvestigator Brochure, CRF etc.)-Post-Marketing Surveillance: Feedback from the customer, complaint handling, writing and handling of CAPA’s and follow-up on the action items), according to Swiss Regulatory Requirements, local applicable Regulations and MEDDEV 2.12-2-Contribute in writing of Clinical Evaluations in accordance with Annex X of Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EEC and based on MEDDEV 2.7.1:2016 -Perform pre-study visits, selection of potential investigators , site initiation visits and co-monitoring visits-Deliverables should meet quality standards and meet company timelines. Achievements: Increase knowledge in the Medical Devices’ field



INC Research

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Site Identification Specialist II

  • Apr 2016 - Dec 2016

  Phase I, II, III clinical trials in various indications.Main activities: Responsible of the following:-Establish and maintain relationships with key investigators, perform the identification of suitable sites for a study and coordinate global efforts for site identification.-Act as primary contact with investigational sites to collect data for feasibility, site ID and building the investigator database. Track and QC data.-Interact with internal and external personnel to coordinate the collection of feasibility and Site ID data and support rapid start-up of sites as needed.-Interfacing directly with the project director of the study and being primary contact for the sponsors regardins site identification. Participate in Kick-off meetings explaining Site-ID procedures and status to the sponsorAchievements: Increase communication skills as acting as interface with investigators at a global level in various indications



Telormedix SA

• Clinical Operations Associate

  • Jan 2008 - Dec 2015

  Clinical Trials : phase II clinical projects in immunotherapy of Bladder Cancer. Main activities : Collaboration with the Head of Clinical Operations and management of the following : -Drafting of protocol, clinical study report review of tables, listings and figures, Investigators' Brochure, Briefing Documents and conduct quality review of the essential documents. -Contribute in the preparation of an IND application. -Interact with auditor for the preparation and conduct of site audits and in house audits, and assist the auditor during audits. -Assist in the selection of CROs and other external vendors -Verify the performance of the CROs and interface with the management for resolution of issues : ensure G(X)P compliance, adherence to SOPs, EMA and FDA regulations. -Deliverables should meet quality standards and meet company timelines. -Perform pre-study visits selection of potential investigators , site initiation visits, co-monitoring visits and close-out visits. -Organize international Clinical Advisory Meetings and Investigator's meetings. -Set up, control and update of a paper and electronic Document Archiving System of essential documents relating to non-clinical and clinical activities for due diligence purposes. Additional activities: -Contribute to the preparation and revision of Telormedix guidelines and SOPs conduct training on SOPs and ensure that training activities related to G(X)P, EMA and FDA regulations are conducted. -Handle the internal CAPA's and follow-up on the action items. Follow-up on CAPA's of CRO's after audits. -Assist the QA consultant and handle internal deviations in order to ensure that quality standards are applied by the personnel.Achievements : Contribute to the successful development of a novel therapy for bladder cancer from preclinical to end of Phase 2 meeting at FDA in March 2014



mondoBIOTECH AG

• Switzerland
• Food Production

• Clinical Assistant

  • Aug 2005 - Jan 2008

  Clinical Trials : Phase II clinical project in pulmonary and systemic vasodilation for the treatment of PAH_Pulmonary Arterial Hypertension . Main Activities: Collaboration with the Clinical Project Manager and management of the following : -Planning and coordination of clinical trials. -Set-up and update of the study documentation Trial Master File. -Collaboration with CROs and consultants for the preparation of study -Protocols and supporting documentation for INDs and CTAs. -Assist the Quality Assurance consultant during external audits. -Writing and updating SOPs. -Preparation and coordination of International Steering Committee and Investigators meetings.