Pharmaceutical consulting support and clinical trial management providing coordination for pharmaceutical clients
with investigators, contract research organizations, contract manufacturers and packagers from project start through completion.
Success built on a solid foundation assuring GxP compliance for Phase I through IV clinical studies.
More than 25+ years of global Clinical Project Management full time experience and contract experience
Work includes outsourced vendor management, contract/budget negotiation, project planning, IND submissions and project resourcing experience from program startup through study completion
Therapeutic space includes Oncology (including pediatric), Rare Disease, Renal, Anti-Infective, Inflammation, Ophthalmology, Dermatology, CNS, Cardiovascular and Metabolism
Significant cross-functional work experience
Based in the Northern New Jersey, available to travel for meetings
Services include Project Management and Clinical Trial Management support for:
Interim management and collaboration with CROs, CMOs, clinical investigators and partners
Development of study start-up materials, case report form and EDC design, IVRS design, study drug planning, Investigator site training
Coordinate clinical and operational activities in the planning and execution of a project.
Contract negotiations for outsourced services (Sponsor and CRO Side Bid Defense)
Data collection design and review
Update key stakeholders and global team on study status, progress, timelines, risks, and contingency plans, including weekly updates to trial management systems, monthly reporting to management, and annual safety updates.
Negotiations for comparator drug procurement
Double-blind design, packaging and labeling oversight
Study drug logistics and reconciliation
Co-monitoring of clinical study sites and laboratories
Protocol writing and review
Inspection Readiness
Double-blind design, packaging and labeling oversight
Contribute to preparation of CTD (ICH Common Technical Document)