Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.
Job Summary:
The Manager Centralized Visit Report Reviewer position independently leads, manages, and motivates a team of CVRRS to a standard consistent with Precision for Medicine’s values and overall focus on quality. The Manager will ensure reports reviewed & approved in accordance with applicable SOPs/plans, regulations, and ICH GCP principles.
Essential Job Functions:
- Develop, mentor, coach and manage CVRRs, and PCVRRs to progress their skillset as per Precision for Medicine quality standards. Advocate individual growth and career development
- Work with the Clinical Operations Management Team and management of other functional areas to continually improve and enhance CVRR expectations and procedures to promote quality, consistency and efficiency while achieving established Key Performance Indicators (KPIs)
- Collaborate with the Resourcing team to ensure resource allocations and needs are appropriately met
- Generate action plans and provide developmental/strategic oversight to optimize CVRR services, with a focus on high quality delivery of individual/team/departmental goals
- Provide on-going feedback and development to manage the performance of direct reports.
- Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals, and deliverables) to assigned CVRRs
- Ensure all assigned CVRRs have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
- Ensure CVRRSs uphold high quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
- Ensure CVRRs provide timely and accurate updates of all required administrative material (SOPs, timesheets, etc.) on company systems.
- Recognize, exemplify, and adhere to Precision’s values that center on our commitment to quality, our people, clients, and performance
- Perform other duties and departmental initiatives as assigned by Leadership.
Qualifications:
- Bachelor’s Degree in a life science-related field (nursing, medical, physiology, pharmacy, etc.) or relevant/equivalent combination of education, training, and experience
- 8+ years of industry experience in clinical research, including clinical operations experience in a pharmaceutical company or CRO, or proven competencies for this position.
- 2+ years of experience in the line management role.
- Working knowledge of ICH GCP guidelines and the clinical development process.
Other Required:
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
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What We Do
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.
