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CRA (St. Petersburg and Moscow, Russia)
Must have an MD, Ph.D. or equivalent professional degree within the pharmaceutical industry.
Three or more years of monitoring experience is preferred, however other relevant experience will be considered.
Head of Clinical Data Management
GCT is looking for a seasoned professional with the sound knowledge and broad experience to take on the leadership of GCT’s Data Management.
Position summary & primary responsibilities
Take on the leadership of the strategy development and continued evolution of GCT’s Data Management.
Responsible for the delivery, quality and integrity of GCT’s clinical data globally across numerous studies in varying phases and therapeutic areas.
Provide support to Clinical Operations, Regulatory, QA, IT teams, participate in development and review of clinical research documents, SOPs, etc.
Oversee the development of clinical Data Management Plan, CRFs/ECRFs, EDC, user requirements, edit rules/checks, query logic and data validations.
Select, negotiate and contract external vendors. Develop Data Transfer Agreements between external vendors/labs.
Perform routine maintenance of EDC user management, provide user training and create study guides.
Prepare the data for statistical analysis, coordinate the archiving of the study data.
Collaborate with Clinical teams, Vendors, IT team to address requests, plan and implement changes.
Ensure data management system compliance with the industry guidelines, international, national Regulatory Authorities requirements, GCT SOPs.
Bachelors of Science degree required, Master of Science or better scientific degree in the related field preferred.
Ten years of relevant experience in pharmaceutical research environment, supervisory and management experience preferred. Other relevant experience will be considered.
Knowledge and understanding of vendor processes and best practices in outsourcing.
Data Management and clinical trials expertise, understanding of clinical development processes and data analysis operations for clinical trials reporting and global regulatory submissions.
Being up-to-date with regulatory requirements and relevant data standards (CDISC, 21 CFR Part 11, ICH/GCP).
Strong communication (written and oral), leadership, decision-making, influencing, negotiation and project management skills.
Sound knowledge and experience working across international borders and cultures.