René Pulles Email & Phone Number

Nijmegen, Gelderland, Netherlands

GCP-Service International is a full service CRO. It has been founded by Andreas Grund in August 2004. GCP-Service provides the pharmaceutical and medical device industry with following services:Training and ConsultingE.g. applicator for submission to Ethical Committees, central and local MOHs / preparation of patient information and informed consents / review of drug labelling/ Review of study protocols) / CRA-Field Training / In-house Training in ICH/GCPClinical MonitoringPre-study / Initiation / Monitoring / Close Out Visits according to ICH/GCPProject ManagementLead CRA / Project Management / Quality Risk ´Management (ICHQ9)Quality Assurance/ GCP-AuditsTMF audits / On-site audits / Un-blinded CRA (quality control of pharmacies)Data Management/StatisticsOwn EDC system, CDISK memberProduct SafetyFull clinical study safety service for drug and medical device studiesVisit us:https://www.gcp-service.com/

Clinical Research Manager responsibilities• Responsible for ensuring study start-up;• Responsible for implementation of monitoring;• Responsible for correct and timely study termination;• Feasibilities;• In conjunction with project team members participate in the development of study procedures;• Review staff timesheets/expenses and creating reports for Finance/Administration;• Responsible for supervision, coaching, training and development of employees (line management and resource management);• Involvement in recruiting process new staff;• Involvement in resource allocation for new projects;• Assist the Managing Director as requestedSrCRA responsibilitiesResponsible for coordination & monitoring of studies in The Netherlands and Belgium including the following activities:• Regulatory submissions to Ethics Committees;• Regulatory submissions to Competent Authorities;• Feasibility studies;• Site-Selections;• Pre-study visits;• Site Initiation;• Monitoring;• Study Closure;• Providing ICH-GCP training;• Contract Negotiations.

Responsibilities• Representing Medpace Netherlands b.v. in day to day business• Interviewing and screening of candidates• Control of the financial status of Medpace Netherlands b.v.• Coordinating the training of new employees• Control and approve of not project related payments• Conduct feasibilities for new trials• Supervision and coaching of CRA’s• Evaluation of CRA’s.• Independently coordinating of (complex) clinical trials• Feasibilities

Responsibilities• Independently coordinating of (complex) clinical trials

Responsibilities• Coordinating of clinical trials

Responsibilities• Direct relations management in the assigned territory at achieving projected objectives and the realization of desired growth

Master’S Degree Biology, Differentiation Chemical/Physiology

Education record

Education record