2

candidati

full time HEAD OF CLINICAL OPERATIONS (Balerna-CH)

Full time

presso OSM NETWORK SA a Mendrisio

OSM Network SA Search for our client:

APR Applied Pharma Research s.a. (“APR”) is a Swiss, independent Pharma Company. APR identifies, develops and commercialize innovative Products (i.e. Medical Device, Medical Food, Orphan Drugs) in niche/rare diseases on a global basis.
To expand the R&D Department in Balerna (Switzerland), creating a new Clinical Operations team, APR is looking for a:

HEAD OF CLINICAL OPERATIONS
(Balerna-CH)
We are seeking a strongly motivated professional with experience as Clinical Research. The person will report to the Pre-Clinical Director and Clinical Director and there are no managers reporting to.

Among key responsibilities are:

• to conceive the study synopsis and drawn protocols of clinical studies for new Products and/or new indications;
• to plan the clinical development strategies of assigned Products in the different therapeutic areas;
• to explore new ideas for clinical trials or new therapeutic areas in both the pre-registrative and post-marketing authorization setting;
• to coordinate clinical activities associated with study start-up and management in Europe, US and, if required, worldwide;
• to select and involve Clinical Investigators in spontaneous clinical experiences/Investigator’s initiated trials or APR-sponsored trials on the assigned Projects/Products and/or key opinion leaders (KOLs);
• to coordinate clinical activities associated with study start-up and management in Europe, US and, if required, worldwide;
• to select of CROs/vendors/clinical centers/Clinical Investigators, and work closely and effectively with them;
• To take actively part to the audits to CROs, if required by the Head of Quality Function;
• to prepare & review all the relevant study documents including synopsis/protocol, subject information & informed consent form, study guidelines, monitoring plans, investigator brochures, CRFs, and clinical study reports;
• To participate to Advisory Boards (planned and coordinate by the Medical Affairs)
• to coordinate, participate to and/or execute Investigator meetings related to the planning and execution of clinical trials, and interpretation and leveraging of clinical trials’ results;
• To prepare and monitor the budget of clinical studies
• to maintain study timelines and monitor study progression;
• to get involved in co-monitoring activities, when required;
• to review of data listings;
• to coordinate study-level investigational product arrangements, accountability and reconciliation; participate in and support investigational study teams, if required, or CRO teams;
• to provide input for screening and enrolment progress, and identify barriers to screening and enrolment and provide solutions;
• to establish solid and professional relationships with existing partners (licensees) and CROs/vendors/clinical centers/Clinical Investigators;
• to continue to increase knowledge of clinical research, clinical operations, and relevant therapeutic areas;
• To draft and/or update the Standard Operating Procedures (SOPs) related to the Clinical Affairs activitiesTo prepare Clinical Evaluations according to MEDDEV 2.7/1:2016 Rev.4 and Annex X of Directive 93/42/EEC; Clinical Evaluations according to MEDDEV 2.7/1:2016 Rev.4 and based on Regulation 2017/745.

Experience & Qualifications:

The ideal candidate should preferably have:
• not less than 8-10-year experience in Clinical Research in CROs or pharmaceutical companies with international presence;
• experience of different stages of study execution (study design and set-up, feasibility, start-up, maintenance, close-out);
• excellent communication skills, and ability to proficiently navigate a matrix management environment;
• good knowledge of the English language (basic knowledge of German language is appreciated), competence in MS Office package, and availability to business travels.

We offer:

• an office-based position, with employment contract and a fixed salary;
• opportunities for professional development and courses;
• chance of taking responsibility and being part of a dynamic, young and growing team.

To formally apply, please submit your resumè/CV, NOW!

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Pubblicato il 12-02-2020
Visualizzato: 214 volte