Hélène Viala Email & Phone Number

Toulouse, Fr

Part of the Clinical Study Team as the Medical Expert for a pivotal phase 3 study.Contribute to medical monitoring and medical data review.Respond to clinical and medical questions from investigator sites.Track, analyse and report safety events.Contribute to BICR meeting.Prepare materials for investigators.Key contributor to pre-database lock activities.

Contributed to the establishment of the French affiliate and the expansion of Seagen footprint in my region.Support launch activities (advisory-boards, educational meetings, meet-the-expert meetings, one-to-one meetings).Support clinical development (identify new sites, participate in PSV, SIV and follow-up visits, raise awareness).Organised successfully 3 medical symposia for different national congresses.Involved in multiple solid tumors to support Seagen marketed product and on development pipeline.

Toulouse, Midi-Pyrénées, France

Identify and communicate with Key External ExpertsProvide the latest scientific and medical informationOrganise regional advisory boardsIdentify clinical study sitesParticipate in Site Initiation Visit and maintain study site interest throughout the study Identified 5 approved externally-sponsored projects (clinical and non-clinical) and provided support throughout these projects in my region.Immuno-oncology & targeted therapies

part-time secondment.Lead the team of 4 MSL during COVID-19 pandemic.Maintain motivation and team spirit.Support field activities transition to remote work.

Part-time secondment.Part of the european medical affairs team for pre-launch activities in bladder cancer. Chair meetings with the local teams to identify gaps in patient journey in each top 5 countries in Europe.

Rueil Malmaison

Primary point of contact between AZ and the Sponsor-Investigator/Researcher for operational activities throughout the life cycle of the externally-sponsored study (academic clinical trials):- organise internal review meetings,- liaise with internal stakeholders,- communicate the outcomes to the Sponsor,- facilitate and lead the Research Agreement execution, - collect the regulatory documents required for the research, distributes the Investigator Brochure,- facilitate payments in accordance with the Research Agreement,- arrange for drug supply- ensure compliance with all applicable policies and processes,- provide end user support and training for process.Key contact for internal and external stakeholders.Cross-functional activities.

Singapour

Responsible for coordination and advancement of New Vaccine Projects in Asia-Pacific Region :- Dengue Vaccine – efficacy and safety study in Thailand, - Clostridium difficile Vaccine – multi-national efficacy study in 15,000 Subjects: North America, Europe, Latin America and Asia-Pacific (25 sites in Australia, South Korea, Taiwan and Singapore).My activities:- Chair weekly clinical team meeting, share updates and ensure issues are resolved promptly,- Work closely with different functions/platforms to resolve bottlenecks and complete tasks,- Develop country specific investigator fees budgets and adjust contracts to countries requirements,- Control activities sub-contracted to third party, - Spearhead the projects to develop new recruitment strategies,- Manage the closure activities of a clinical study,- Contribute in pre-approval inspection preparation,- Chair brainstorming sessions to prepare health authority inspections.My achievements:- Negotiated 25 contracts within tight timelines despite cultural challenges (Au, Kr, Tw, Sg),- Organized a successful Investigator’s meeting with more than 100 participants from Au, Kr, Tw, Sg and US,- Simplified Investigator fees payment process by innovatively creating the payment guideline for Investigator. ---received the Global Achievement Award for Operational Excellence

Région De Paris, France

Phase III multi-national study in cardiology: - Perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations in France. - Conduct site visits to assess protocol and regulatory compliance and manages required documentation (site initiation visits, interim monitoring visits, close-out visits). - Audit: provide support and timely follow-up to ensure corrective and preventive action plan.

Région De Toulouse, France

- Prepare dossier for submissions to Health Authority and Ethics Committees (France) - Protocol, ICF, paper CRF assessment - Investigator’s meeting organisation.

Newcastle Upon Tyne, Royaume-Uni

Research scientist in the oncology labsAssay by HPLC and UV detection.

Toulouse, France

[part-time 3 months] Neurosurgery department: drug prescription monitoring[part-time 3 months] Pharmacy department: manage drug supply for Clinical trials

Docteur En Pharmacie - Pharmd (Thèse En Cours), Filière Industrie

Master 2, Clinical Trial Management

Du Cesam, Centre D’Enseignement De La Statistique Appliquée À La Médecine Et À La Biologie Médicale

Modules: - MÉTHODOLOGIE STATISTIQUE (METHO) - RECHERCHE CLINIQUE (STARC)