Clinical Trial Manager (CONTRACT)

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Requirements:

• BA/BS degree with 7 + years of combined 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, trial planning and management, and CRO and vendor oversight.
• Excellent verbal and written communication skills.
• Proven ability to work effectively across functions.
• Expected travel up to 20%.

Responsibilities:

• Lead and/or support unblinded and blinded 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 regular updates on trial progress/performance to internal stakeholders.
• Oversee clinical monitoring from site qualification to site closure visits to assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records.
• Oversee the review/cleaning and reconciliation of clinical data, including EDC, PROs, and 3rd party labs to support timely database lock and the accurate analysis of clinical data.
• Partner with relevant stakeholders to develop and implement appropriate study-specific training to all relevant study-related personnel (internal, CRO, Site staff, and other relevant 3rd parties).
• Support monitoring activities and visit clinical study sites as needed.