Senior Clinical Scientist; MD; Swiss​/UK​/Spain​/non

Overall

Purpose:

The GARDP Snr Clinical Scientist (MD) will provide medical, clinical and scientific study and project support primarily for clinical studies (phase I to IV) within a clinical project(s), but also flexibly to enable and support scientific work streams at the cross project and portfolio level. They will work in collaboration and with oversight from the Medical Lead at the study and the clinical project level to develop clinical science strategies in support of the clinical development plan.

Priority activities for the Snr Clinical Scientist will include:

· Study and protocol design, implementation strategy, and training,

· Clinical data review and interpretation

· Safety review and coordination with Drug Safety

· Clinical study implementation, support and oversight to ensure patient safety, scientific validity and data integrity/quality in alignment with GARDP procedures.

· Preparation and/or review of study-specific and regulatory documents, study reports and scientific publications.

The Snr Clinical Scientist (MD) may also lead implementation of a drug/treatment project identified by the Project Lead and/or Associate Director Medical Sciences/ Medical Lead.

Contribution

They are accountable for delivering clinical/Medical Science support and strategies via clinical project and study level work streams directly or indirectly via external collaborations or via oversight of expert services/consultants.

Scope of Work (Results)

The role delivers integration of clinical science with clinical operations, interpretation of evidence, data and advice to support the performance of assigned clinical studies and project work streams.

Clinical Study oversight – General

· Medical/clinical science oversight of specific study activities providing scientific guidance during the execution of the study as directed by the Associate Director Medical Sciences/Medical Lead role for the study including those conducted via a CRO.

· Co-ordination of Medical Science support and integration with operations and CRO activities

· Provide the medical input to the development of the Site Monitoring Plan

· Write the Medical Monitoring Plan and liaise with programmer to determine data outputs needed to execute this plan

• Answers specific site management protocol questions as needed
• Assists in medical issue resolution (study wide, escalated regional/site)
• Provides input during vendor selection for specific clinical/protocol issues

· At study level, provide safety monitoring support with overview provided by Drug Safety Scientist and Associate Director Medical Sciences/Medical Lead

· Support the track and reconciliation of SAEs across a study

• Support timely communication of safety issues to sites
• Write and/or review patient narratives as agreed with the Associate Director Medical Sciences/Medical Lead and Drug safety scientist

Clinical study design, protocol development and set-up

• Lead design strategy discussions where appropriate
• Draft study design concepts/synopsis, protocols and amendments in collaboration with study operations lead/clinical trial manager, Associate Director Medical Sciences/Medical Lead, statisticians, and others where appropriate
• Draft and provide specific clinical/protocol training for investigator meeting, site personnel for initiation visits
• Provide scientific input on country and site feasibility as requested by the study operations lead/clinical trial manager and/or Associate Director Medical Sciences/Medical Lead
• Support the preparation and review of clinical documents including informed consent templates

Clinical and laboratory data review and interpretation

• Provide medical/clinical input to study design aspects including data collection, review, analysis, and database set-up
• Provide input for the design of the Statistical Analysis Plan (SAP) and the clinical data programmed output
• Responsible for review of patient level clinical and microbiological data across a study, to focus on identifying trends and supporting interpretation, in co-ordination with Associate Director Medical Sciences/Medical Lead for study level review
• Support for end of study procedures including table and listings design…