Job Description

What you’ll do:

• Responsible for the overall coordination and management of clinical trials from start up through the final project deliverable
• Manage and lead cross-functional study teams, including third-party vendors to ensure successful completion of all components of assigned studies per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Direct the projects technical, financial, and operational objectives.
• Partner with the Business Development group to develop strong relationships with current and

prospective clients to generate new and/or add-on business for the future.

• Work to ensure that all project deliverables meet the customer’s time/quality/cost expectations.
• Lead study startup process, including but not limited to conduct of the study Kick-Off Meeting, developing the project operating plan, the set-up of CTS study file, and vendor Clinical Trial Agreements and budgets.
• Provide updates on trial progress and other relevant tracking details of study progression to the Executive Director of Project Management and other stakeholders, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
• Ensure effective project plans are in place and operational for each trial and work proactively with the clinical trial study team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
• In partnership with Vendor study team, monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the clinical team to ensure vendors performance to meet study needs.

Pay Range
The typical pay range for this role is:
Minimum: 60,300
Maximum: 126,600

Please keep in mind that this range represents the pay range for all positions in the job grade within which this position falls. The actual salary offer will take into account a wide range of factors, including location.

Required Qualifications

• 5+ years of clinical industry experience including demonstrated experience and competency in clinical project management tasks/processes, ICH Guidelines, GCP including regulatory requirements for the conduct of clinical development programs including clinical study design, study planning and management, monitoring, data collection, study documentation.
• Ability to travel for business up to 25%.

Preferred Qualifications

• Experience coordinating study activities for multi-center studies
• Knowledge of Clinical Trial technology systems

Education

• Bachelor’s degree or equivalent experience