Clinical Research Project Manager – CVS Remote Jobs

Job Type: Clinical Research Project Manager from home
Location: Colorado work from home
Company: CVS Health

CVS Clinical Trial Services, a newly formed CVS Health subsidiary, is one of the company’s initiatives to advance and transform health and healthcare. We put the patient at the center of everything we do as we redesign and innovate trial delivery and real-world evidence generation. We are a dynamic team with the advantage of working in an entrepreneurial environment where unconventional thinking and approaches are not only rewarded, but also encouraged. At all levels, ownership and the ability to shape the way forward are empowered to accelerate progress and innovation. Colleagues here collaborate not only within our organization, but also across the CVS Health matrix, working as one team to achieve our goals, deliver solutions, and shape the future.

The Clinical Research Project Manager is in charge of overseeing all aspects of study services for which CVS Health has a contract with a pharmaceutical, medical device, or related health care sponsor. As the primary point of contact for the sponsoring companies, you will be in charge of overseeing the delivery of all contracted services.

Responsibilities:

• Responsible for the overall coordination and management of clinical trials from inception to completion.
• Manage and lead cross-functional study teams, including third-party vendors, to ensure that all components of assigned studies are completed in accordance with project team goals and objectives and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.
• Direct the technical, financial, and operational goals of the project.
• Collaborate with the Business Development team to build strong relationships with current and prospective clients in order to generate new and/or additional business in the future.
• Work to ensure that all project deliverables meet the time/quality/cost expectations of the customer.
• Lead the study startup process, which includes, but is not limited to, holding the study Kick-Off Meeting, developing the project operating plan, creating the CTS study file, and negotiating vendor Clinical Trial Agreements and budgets.
• Update the Executive Director of Project Management and other stakeholders on trial progress and other relevant tracking details of study progression, including 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 that effective project plans for each trial are in place and operational, and work proactively with the clinical trial study team to set priorities in accordance with applicable project plans, company standard operating procedures (SOPs), ICH/GCP guidelines, and regulatory requirements.
• Monitor the quality of vendor deliverables in collaboration with the vendor study team, 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 Scale

The typical salary range for this position is: 60,300 minimum; 130,000 maximum

Please keep in mind that this range represents the average pay for all positions in the job grade in which this position is located. The actual salary offer will consider a variety of factors, including location.

Requirements:

Qualifications Required

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

Qualifications Preferred

• Experience coordinating multi-center study activities
• Education in Clinical Trial Technology Systems

Education: Bachelor’s degree or comparable experience