Mandy Bosch - van de Pas

Per4mance Training & Coaching aims to improve performance in clinical research by developing on-line, virtual and classroom training programs that focus on the development of skills.

• Answering questions and providing advice on ICH-GCP, SOPs, regulations and guidelines. • Design, organization and delivery of on-line and classroom training programs for department staff to further increase knowledge on ICH-GCP, SOPs, regulations and guidelines. • Involved in several projects aiming to align controlled documents across departments and functions. •Leader and facilitator of several projects aiming to document the main departmental clinical trial activities in a process map

•Delivering standard and ad-hoc training to Clinical Trial Administrators, Clinical Research Associates, Clinical Team Leaders and line managers across Europe, with focus on ICH-GCP, international laws and guidelines, Standard Operating Procedures (SOPs), GMP, coaching, project management, leading teams, communication, working in teams, 4 day line management training. • Development and delivery of several training courses on ICH-GCP for physicians. • Design and delivery of communication program for CRA

• Outsourced as study manager for medical device (cardiovascular) trial in 10 countries (quality, conduct, time-lines). Lead international project team. • Coaching junior CRAs on 3 large international clinical trials. Coordination of the local project teams for these trials. Site selection visits and project start-up. • Member of project start-up team.

• Responsible for 3 respiratory clinical trials within the Netherlands. (quality, conduct, time-lines, budget). With regard to project-related tasks, lead local project team.

• Several tasks in large international cardiovascular trial. Co-monitoring, training, CRO management, organisation of investigator meeting and social event for 200 investigators. Involved in trial management at operational level. • Site management and in-house quality check of CRFs for international neurological trial, organisation of international CRA training. • Global CRA coordinator for international neurological trial. Involved in trial management and decision making.

July 1996-July 1997: In-house CRA for large international cardiovascular trial. August 1997-February 1999: Field CRA for large international cardiovascular trial.

Supervise implementation of Electronic Patient File in practice of family doctor and interpretation/data entry of patient records.

Performing scientific research in the field of the Human Immunodeficiency Virus (HIV). Supervise HLO and University students during learning project.

Immunology Microbiology