Clinical Trial Manager

USA/Remote


Key Responsibilities:

• Manage the operational aspects of assigned clinical trials

• Participate in protocol, CRF development, Clinical Study Report preparation, as appropriate

• Proactively identify potential study issues/risks and recommend/implement solutions

• Manage CRO and other vendor interactions to ensure appropriate sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files, sample management)

• May work with CRO to develop and revise site budgets, plans, and detailed timelines, and ensure that performance expectations are met

• Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)

• Review site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments

• Provide oversight for clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations

• Review monitoring trip reports to ensure issues are identified as appropriate and to ensure any issues are followed to resolution

• Manage set-up and User Acceptance Testing (UAT) of electronic data management system

• Manage set-up and UAT of IWRS system

• Establish and maintain sound clinical and data collection practices to ensure validity of data and ensure that results reporting timelines are met

• Organize and manage internal team meetings, investigator meetings, and other trial-specific meetings

• Ensure that the progress and completion of trial(s) are in-line with the agreed upon trial goals/targets such as enrollment, active sites and other milestones, to meet the corporate goals

• Contribute to the development, forecasting, monitoring, and reporting of assigned clinical trial budgets

• Provide oversight and management of investigator payments

• Review study accrual reports to ensure all operational items for assigned trials have been accrued in a timely manner

• Prepare metrics and updates for management, as assigned, by tracking and reporting clinical trial information and progress regarding patient recruitment, screening, monitoring, clinical and laboratory (PK/PD) data, data cleaning status for assigned trials/programs, etc.

• Contribute to the Request for Proposal (RFP) process, review vendor proposals and participate in vendor selection process for outsourced activities

• Serve as a liaison and resource for investigational sites

• Recommend and implement innovative process ideas to impact clinical trials management

 

 

Requirements:

• BA/BS or equivalent degree in scientific discipline

• Minimum 5 years of clinical trial management experience in biotech

• Experience in managing outside vendors, e.g., CROs and other vendors

• In-depth understanding of industry standards and applicable guidelines; FDA regulations and ICH GCP knowledge

• Strong collaboration and team communication skills

• Strong critical thinking and problem-solving skills

• Ability to prioritize and manage time demand, incomplete information, and unexpected events

• Good understanding of data management, statistics and medical writing processes for clinical development

• Excellent organizational skills

• Advanced computer literacy

• Fluency in spoken and written Chinese highly desirable

 

Contact

HR@hightidetx.com

 


We will contact you as soon as possible

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