Katy Kerschen Email & Phone Number

Switzerland

Zurich, Switzerland

𝐖𝐞 𝐟𝐨𝐜𝐮𝐬 𝐨𝐧 4 𝐤𝐞𝐲 𝐚𝐫𝐞𝐚𝐬:🔺𝑨𝒅𝒗𝒂𝒏𝒄𝒊𝒏𝒈 𝑾𝒐𝒎𝒆𝒏Increasing the representation of women in board and corporate leadership🔺𝑪𝒐𝒏𝒏𝒆𝒄𝒕𝒊𝒏𝒈 𝑾𝒐𝒓𝒌 & 𝑻𝒂𝒍𝒆𝒏𝒕𝒔Sponsoring Women/Talents programs for organizations to attract, recruit, and retain female talents and leaders 🔺𝑴𝒐𝒓𝒆 𝑫𝒊𝒗𝒆𝒓𝒔𝒊𝒕𝒚, 𝑬𝒒𝒖𝒊𝒕𝒚 & 𝑰𝒏𝒄𝒍𝒖𝒔𝒊𝒐𝒏Taking Diversity, Equity & Inclusion to the next level🔺𝑷𝒓𝒐𝒗𝒊𝒅𝒊𝒏𝒈 𝒂.

Root, Lucerne, Switzerland

• Oncology/Medical Devices
• Assists in leading Lung cancers therapeutic area program
• Member of Global Clinical Operations Extended Leadership Team
• Leads process improvements and initiatives to enhance operations (includes SOP writing)
• Line Management
• Accountable for project financial planning, management, and change control

Root, Canton Of Lucerne, Switzerland

• Senior CTM: Oncology / Medical devicesPhase II and Phase III (Pivotal trial) trials
• Oversee all areas of Clinical Trial Management for Medical Device Studies
• Ensuring GCP and ISO requirements are followed
• Management of Contract Research Organizations (CROs), vendors and Investigator sites
• Contract and Budget oversight
• Line Manager for Clinical Trial Associates

Zürich Area, Switzerland

• Global CTM for phase I Oncology study (USA and Europe)Global CTM for phase II Pain study (Europe)
• Subject matter expert for investigator payments set up/system
• Mentors CTMs / CRAs
• Leads/participates in ICON initiatives for process improvements accross functional lines
• Reviews and inputs into protocol and protocol amendments
• Responsible for investigator and site selection, including feasibility and pre-trial assessment

France

• Lead CTM for a program of phase III Gastrointestinal studies (USA and Europe)
• Reviews and inputs into protocol and protocol amendments
• Responsible for investigator and site selection, including feasibility and pre-trial assessment
• Selection of national coordinating investigators as needed per country
• Oversight of study start up ensuring site initiation occurs according to timelines
• Oversight of site contract and budget negotiations

Geneva Area, Switzerland

• Central lab project manager across 10 studies in various therapeutic areas
• Acts as the primary liaison between the Sponsor and Covance Central Laboratories
• Accountable for the review of the clinical protocol to define feasibility, assess risk and provide consultative approach for the lab database and lab kit design
• Responsible for the study set-up, database design and closely monitoring critical study milestones
• Pro-actively manages the assigned budget and taking appropriate actions as needed
• Manages day-to-day project related activities including the implementation of CAPAs as needed

• CTM for Phase I Oncology study (AsiaPac, Europe) CTM for Phase III Inflammation study (Europe) CTM for program of Phase III Pulmonary Arterial Hypertension studies (AsiaPac, Europe & USA)
• Delivering the operational aspects of clinical studies from protocol feasibility through database release. Primary deliverable is high-quality, timely and cost-effective data
• Oversight of a Global set of countries to ensure the Protocol and Monitoring Plan are consistently and appropriately implemented across investigator sites and country operations
• Oversight of study vendors, including Central Labs.
• Proactively identifies and resolves study operations-related issues as they arise
• Develops study level documentation including; monitoring plans, informed consent documents, subject directed recruitment materials and site training/procedure binders

• Supervision of the administration department, including line management of administration staff
• Management of monthly account reconciliations for >30 insurance companies, processing timely payments, raising and resolving account queries
• Managing debtors and creditors reports, pursuing outstanding payments and issuing refunds where due
• Staff training
• Ensuring compliance of FSA regulations in the day to day work procedures of the administration department

Bsc, Bachelor Of Science Degree “Open”

A-Level Equivalent, Natural Sciences, Pass

Good Clinical Practice And Clinical Research Diploma, Clinical Research

Syllabus: Guidelines & regulations: Design & analysis of clinical trials: Process of conducting a clinical trial:

Effective Clinical Trial Project Management, Project Management

Syllabus: Definition of project management terms The role of the project manager The life cycle of a project Defining a project and.

Education record