Oversee and direct project management, quality systems, client relations and reporting for clinical services.
Key areas of Responsibility:
Participates in the development of clinical study protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents and study reports; participate in composing the clinical contribution to IND’s, Investigational Brochure, regulatory Briefing Documents, and other relevant documentations for regulatory bodies in accordance with GCP and ICH guidances.
Contributes to the strategic planning, authoring and review of regulatory submissions and scientific data disclosures, as required.
Coordinates medical and safety responses to support regulatory information requests from clinical studies.
Works with Clinical Services to ensure the acquisition and maintenance of appropriate IRB and related approvals and safety updates.
Interact with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic area and with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plans.
Maintains medical/scientific standards, educating team members & managing the Scientific Advisory Board (SAB)
Interacts with regulatory agencies, in connection with the Regulatory Affairs Department.
Represents project(s) to corporate partners, investors and clinical investigators as required.
Develops and maintains excellent working relationships with investigators, sites and clients.
Works with CRO suppliers to ensure QA/QC compliance and budget.
Ensures consistency of clinical content and scientific messages across publications and materials.
Participates in interactions with sponsors and regulatory agencies.
Works with sales and marketing to provide key review and feedback for new indications and promotional materials.
Contributes to successful development, implementation, execution, oversight, monitoring and completion of clinical trials.
Provides guidance and oversight for the management of clinical trials within sponsors budget and timeline.
Other duties as assigned.
Bachelor’s Degree in Scientific/Health related field. Advanced degree and RAC preferred.
10+ years Clinical Research/Development experience required, including relevant Clinical Trial Project Management experience.
Solid understanding of IND/CTA application process and Phase 1-3 drug development with relevant therapeutic area experience of 3 or more years.
Working knowledge of clinical research design principles, GCP/ICH requirements, and regulatory/safety considerations.
Demonstrated ability to effectively work collaboratively in cross functional teams.
Knowledge of Good Clinical Practice (CGP) and FDA / EMA regulations is expected. Experience with Institutional Review Board (IRB) preparations and submission preferred.
Telecommuting is allowed.
Internal Number: CR2019-1
About CSSi LifeSciences LLC
CSSi LifeSciences LLC
6958 Aviation Blvd., Suite H
Glen Burnie, MD 21061