JULIEN BEAL

From July 2007 to present: Senior Study Coordinator
i3 Research (Ingenix company), France

Based in WYETH Research as Global Trial Leader

Therapeutic Area Experience
• Oncology – 18 months

Clinical Research Projects
• Metastatic Breast Cancer
o Phase I/II, International, combo, dose escalation, 95 patients, 12 countries, 50 sites
o Phase I/II, International, combo, dose escalation, 85 patients, 10 countries, 40 sites
o Phase I/II, International, combo, dose escalation, 50 patients, 6 countries, 15 sites
• Metastatic renal cell carcinoma
o Phase III, International, second line, 480 patients, 15 countries, 120 sites
o Phase III, International, combo, first line, 800 patients, 30 countries, 200 sites

Key areas of Responsibility:
• Plan, manage and execute study
• Feasibility and selection (countries, sites)
• Budget review and approval (vendors, monitoring and clinical fees)
• Plan, facilitate and lead study team meetings (international teleconference and Webex)
• Vendors selection (central lab, IVRS/IWRS, Tumor Imaging, Courier…)
• European Investigator meeting planning
• Create and drive study level timelines
• Review and validation of the site qualification visit reports, site initiation reports and monitoring reports
• Develop study level enrolment plan and enrolment projections
• Interim analysis management
• Writing and review of the study documents (protocol, synopsis, inform consent, eCRF, dispensing form, study reference manual, patient diary, newsletters)
• Collect and report study status for enrolment, data entry, treatment, study materials
• Study drug follow-up
• Regulatory submissions follow-up


From January 2007 to June 2007: Senior Study Coordinator
i3 Research (Ingenix company), France

Based in I.R.I.S. (Institut de Recherches Internationales Servier)

Therapeutic Area Experience
• Cardiology – 6 months

Clinical Research Projects
• Stable coronary artery disease (Phase III, International, multi-centre study – 11000 patients, 33 countries)

Key areas of Responsibility:
• Managment of 5 local countries (Argentina, Australia, Russia, China, Hong Kong) with conference call
• Study data managment, e-CRF, study portal development, metrics follow-up
• Ensure Medical Review process and progress across regions
• Study drug managment
• SAE reconciliation and pharmacovigilance follow-up in collaboration with the PV department
• Project managment meeting with active participation
• Ethic committees and Health Autorities submissions follow-up
• Sponsor trial master file

From August 2005 to December 2006: Clinical Project Manager
Chiltern International, France

Therapeutic Area Experience
• Oncology – 1,5 years

Clinical Research Projects
• Renal cell carcinoma (Phase IIb, International, multi-centre study – 110 patients, 17 sites in France)

Key areas of Responsibility:
• Responsible for 2 CRAs and 1 CTA
• Financial study managment
• Monitoring reports review, quality control of CRF and centre specific file, TMF maintenance
• Monthly reports
• Training to sponsor’s SOPs
• Training to study guidelines
• Sponsor reporting
• Audit


From January 2004 to December 2006: Clinical Research Associate
Chiltern International, France

Therapeutic Area Experience
• Oncology – 3 years
• Gastroenterology – 1,5 years
• Haematology – 1,5 years

Clinical Research Projects
• Renal cell carcinoma (Phase II, international, multicentre study – 100 patients 17 sites in France)
• Metastatic breast cancer (Phase II, International, multicentre study – 55 patients, 11 sites in France)
• Crohn’s disease with fistulas (Phase III, International, multicentre study – 60 patients, 10 sites in France)
• Hypereosinophilic syndrome (Phase III, International, multicentre study – 10 patients, 2 sites in France)

Key areas of Responsibility:
• Feasibility
• Pre-study visits, initiation visits, monitoring visits and close-out visits
• Initial and additional submissions to Ethic Committees and Health Authorities
• Creation of study documents: Synopsis, PIL/ICF, financial contracts
• Study drugs management
• DCFs management
• Administrative and financial follow-up
• Creation and submission of financial agreement template (Investigator, Hospital,…)
• Monthly reports
• Audit

From February 2002 to December 2003: Clinical Research Associate
MDS Pharma Services, France

Therapeutic Area Experience
• Endocrinology – 2 years
• Gastroenterology – 1,5 years

Clinical Research Projects
• Growth hormone (Phase III, International, multicentre study – 400 patients, 30 sites in France)
• Diabetes type II (Phase II, International, multicentre study – 250 patients, 25 sites in France)
• Haemorrhagic recto colitis (Phase II, International, multicentre study – 200 patients, 20 sites in France)

Key areas of Responsibility:
• Feasibilities
• Pre-study visits, Initiation visits, monitoring visits and close-out visits
• Study drugs management
• DCFs management
• CRFs medical review
• SAEs reconciliation
• Administrative and financial follow-up
• Management of CRAs based in European countries
• Creation and submission of financial agreement template (Investigator, Hospital,…)