Senior Clinical Trial Manager

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Requirements:

• BA/BS degree with 7+ years of experience supporting and independently managing clinical trial activities.
• Strong knowledge of ICH/GCP and regulatory requirements.
• Strong experience in the drug development process including trial design and management.
• Excellent verbal and written communication skills.
• Proven ability to work effectively across functions.
• Ability to travel approximately 20% of the time.

Responsibilities:

• Ownership of all operational aspects of clinical trials, including CRO and vendor management.
• Lead and/or support study activities, including vendor evaluation and selection, country and site selection, informed consent development and maintenance, eCRF design and implementation, protocols, study plans and manuals, IBs, CSRs.
• Proactively identify and support resolution/escalation of trial conduct-related issues.
• Manage and lead cross-functional trial teams, including collaborating with internal team members and external vendors for the planning and execution of clinical trials, through closeout.
• Provide regular up-to-date trial information and updates on trial progress/performance to internal stakeholders.
• Oversee clinical monitoring from site qualification to closure visits to assure data integrity.
• Oversee the review/cleaning and reconciliation of all clinical data to support timely database lock.
• Partner with stakeholders to develop and implement study-specific training to relevant personnel.
• Support development of department documentation, such as SOPs.
• Help develop and maintain study budgets.