Pharmacology Technology Project Manager

August 14

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EDC Services • ELN Services • CDM Services • Computer System Validation • Custom Applications Development - Regulated environment

1001 - 5000

Description

• Manage a team of approximately 12 project managers • Define a process for onboarding and continuous performance monitoring • Leads, manages, and directs all project managers within the Clinical Research department • Provides expertise, leadership, and guidance in project management of a clinical study • Provides mentoring, coaching, and development of the project managers • Develops, reviews, implements, and provides training on SOPs and guidelines for clinical project management processes • Assist in preparation of sponsor, regulatory or internal client audits • Participates in sponsor meetings • Assists the Director Operations in the preparation and revisions of requests for proposals, proposals, and budgets • Develops, implements, and maintains technical tools needed for project management activities • Maintain project assignment tools up to date • Responsible for the Clinical Trial Management System and Trial Master File System • Ensures that project managers are working in line with timelines, scope, budget, etc. • Creates and presents regular progress reports and measure of KPIs • Performs all responsibilities of a project manager

Requirements

• Bachelor’s degree in life sciences is preferred • Must have excellent French and English verbal and written communication abilities (mandatory) • A minimum of 7 years of experience in project management within a clinical research environment • Successful management of global studies as well as study sites from study start-up through study maintenance and close-out is an asset • Excellent knowledge of clinical research methodology and solid understanding of clinical studies, ICH-GCP, and other applicable regulatory requirements • High level understanding of pharmacology / toxicology - PKPD / Clinical protocol design during the studies is preferred • Excellent organizational, communication, interpersonal and leadership skills • Must have strong analytical and problem-solving skills

Benefits

• Competitive compensation package including accrued vacation • Medical, dental, vision insurance • 401k with company matching • Life insurance • Flexible spending accounts