Brussels Metropolitan Area
Experienced People & Project Manager with a demonstrated history of working in the pharmaceuticals industry. Strong balanced Leadership style and project management experience, skilled in Biomarkers and translational Medecin, Medical Devices, Good Clinical Practice (GCP), People Management, emotional intelligence and ISO Standards
Lead & Manage in a worldwide matrixed environment ,at sponsor level, human pharmacology studies and program including management of the resources related (internally & externally with CRO alliance partners) to Clinical trials in terms of time, human resources and overall study budget, to reach the study and program objectives in a timely and cost efficient manner with the required level of quality. -Oversight the conduct of all the phases, cross countries (multicentre studies), of assigned human pharmacology studies in Phase 1 & 2 worldwide, from initial sites selection to final report and archival. -Accountable for CTB submission (Bid Grid defend budget) and close follow up. -Operationally lead and coordinate activities of the study team or provide oversight of these duties performed by the CRO Alliance to execute studies in the required countries to deliver timely and high quality study data -design protocol aiming to reach a Faster to Market approach with a clinical and scientific approach. -Creates or contributes to study documents (e.g. Protocol summary, Informed Consent Form, Risk assessment, Case Report Form (CRF), CRF Completion Guidelines, Monitoring Plan, Statistical Analysis Plan, Clinical Study Report ). -Ensures that all contractual, regulatory and logistic requirement are met(in accordance with GxP and other regulatory legislation); -Drives the Clinical Study report writing process with the relevant team members.
- Manage directly a group of 5 Clinical Project Manager & 1 Laboratory Manager (indirectly 10 Laboratory Technician) - More than 15 years of scientific experience in early clinical research development (Phase I/IIa), pharmacology, clinical laboratory, drug discovery, translational medicine, and basic science research. - >9 years of project management experience in multiple therapeutic areas with a demonstrated track record of success - Effective stakeholder manager in a matrix organization - Strong ability aligning team milestones with study goals and on-time completion of deliverables - Recognized as significant contributor to continuous improvement initiatives (CAPA) - Demonstrated proficiency as strategic thinker - Excellent risk management skills - Experience working with line leaders to solve problems - Strong planning and budget skills - Reputation as enthusiastic, positive, self-starter, innovative mindset Specialties: Clinical project management, Leadership, Extensive experience in Clinical research & operations in many therapeutic area , Protocol design, Statistic, ISO 15189, Biomarkers.
People management (supervision of 5 Clinical Research study coordinator) - Performance review (Goals setting up/follow up) - Set standard (establish process to help colleagues being autonomous in their role /monitor system performance via metrics) - Develop colleagues (organize training/create projects with other departments/be innovative) - Interview new candidates based on behavioural interview technic - Use insight training to adapt own style - Identify Talent in his team and develop them as potential successors (as part of the Business continuity plan)
- Main point of contact at investigator site (managing until 6 studies at the same time including mechanistical/Methodology studies) -Organize studies/protocol at the site level (matrix team relationship with the research unit & other WW Pfizer study team) . -Budget: realize Per Subject Cost / PCRU Clinical trial budget -Data management: Build eCRF (PCRU is using his own eCRF system called PIMS) design & resolve queries. Prepare dose review meeting dataset (with Matlab).Data cleaning activity (to ensure data accuracy) -Regulatory submission: writer of Inform consent document (study & Site level) submitted to our Ethics committee -Inspection readiness: answer Auditor queries/prepare audit/proof of GCP/SOP knowledge. -Protocol design: comment protocol to ensure they are remaining feasible from a clinical/operational perspective (with protocol primary objective in mind as well) - Vendor management: build Task Ownership Matrix & contract with vendors - Risk assessment: identify proactively Risk associated to study conduct & define contingency plan.