Karin De Wit Email & Phone Number

Netherlands

South Holland, Netherlands

Leiden, The Netherlands

Leiden, The Netherlands

The Netherlands

The Clinical Research Liaison is a therapy-area-specific position responsible for developing long-term relationships with clinical investigators, enhancing the image and reputation of the company and for providing an interface between the company, the investigator and the service provider in outsourced global trials to create the environment for successful clinical trials.

The Netherlands

Manage the Clinical Monitoring organisation to ensure that trials are conducted with concern for ethics and patient safety and in compliance with Good Clinical Practice and in accordance with the Standard Operating Procedures (SOP’s), Work Instructions (WI”s) and conventions.-serve as local expert for site and study management-maintain excellent relationships with trial sites and EMD Serono’s /Merck Serono’s commercial organisation-plan and manage the operational performance of the Clinical Monitoring organisation to ensure that appropriate targets for time, cost and quality are set and managed.-responsible for recruitment, train, develop and motivate staff. (CRA’s, CML’s, CRL’s, LSR’s)-set goals and objectives in line with department and study goals-manage individual performance including performance appraisal and salary review-forecast, plan, manage and optimize the resources needed for trials run in the country, maintaining sufficient flexibility to respond to changing priorities-serve as the local expert for site and study management, providing input to feasibility, site selection, recruitment plans, local ethics, regulatory submissions and importations as applicable.-provide solutions to local problems in trial management through local knowledge and relationships-build and maintain strong relationships with EMD Serono / Merck Serono commercial management and ensure full collaboration on clinical trial activities performed in the country-promote the consistency and harmonisation of processes and deliverables across trials and locations.-contribute to the development of the country specific budget. -ensure adherence to the budget on an ongoing basis and optimize the spending to yield maximum results.-ensure that project timelines and milestones are met.

To provide local site and study management and central co-ordination of the monitoring function from feasibility to study completion, across all regions, phases and therapy areas.

Rotterdam Area, Netherlands

monitoring clinical studies in different phases and therapeutic areas, involved by start-up processes including submissions to the CCMO/ethics committees, give guidance to starting CRAs (lead CRA), train site personnelSince Nov 2007:Clinical Research Organisation (CRO) contact person; intermediate between International Study Team and CRO: oversight several clinical studies executed by CROs,control submissions to ethics and CCMO,follow up on Safety reports, resolving problems or issues as intermediate between sites, Study team and CRO

Rotterdam Area, Netherlands

responsible for sales several products CNS and cardiovascular

responsible for promoting SAFEHIP and allergy treatment

The Hague Area, Netherlands

responsible for sales several cardiovascular products