Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management within oncology or hemoglobinopathies indications. The successful hire will adhere to best practices ensuring rigor and high-quality execution of clinical trials from FIH through commercial marketing authorization. This person will manage cross-functional relationships with internal and external stakeholders and be the clinical operations representative to the respective program clinical sub-team. This individual will be hands on with trial sites fostering relationship development with KOLs. This is a high visibility position with great impact potential.
• Responsible for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget
• Identify issues and implement solutions to ensure timelines are maintained
• Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress
• Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans
• Develop trial specific training tools for site utilization
• Oversee maintenance of the eTMF
• Work with financial management to reconcile monthly actual and forecast budgets
• Monitor and/or co-monitor clinical trial sites
• Plan and coordinate advisory boards, investigator meetings and CRA trainings
• Work collaboratively with supply chain to ensure seamless collection/manufacture/shipment of cells
• Develop project-specific procedures and processes
• Recommend and follow up on corrective actions
• The candidate must maintain a high standard of professionalism, and confidentiality in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively
• BS/BA/BSN – health/science related field preferred
• Minimum 3+ years' relevant industry experience including at least 2 years of trial management experience.
• Excellent communication, writing and presentation skills
• Demonstrated ability to work independently as well as in a team environment and seek resources as necessary.
• Ability to assess complex issues and propose viable solutions
• Demonstrated ability to lead and organize team meetings
• Ability to foster effective relationships with vendors, investigators and colleagues
• Ability to contribute technical expertise to the various aspects of the clinical trial process.
• Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR
• Proficiency in study monitoring activities
• Knowledge of the infrastructure and operational characteristics of CROs and centralized services.
• Demonstrated effective time management skills
• Must be willing to travel domestically and internationally up to 15-20%
• MS or advanced degree
• 5 or more years in a Clinical Operations Management role
• Global trial management experience
• Prior Clinical Monitoring and/or CRO experience
• Knowledge of First in Human trial management
• Experience with oncology and/or transplant
• Experience with cellular therapy trial management
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