Central Monitoring, Manager at Parexel

Southport, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Mar, 26

Salary

0.0

Posted On

27 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Problem-Solving, Critical Thinking, Communication Skills, Interpersonal Skills, Data Analysis, Statistical Methodologies, Clinical Drug Development, Regulatory Requirements, Quality Control Processes, Auditing Procedures, Microsoft Office, Data Manipulation, Central Monitoring, Risk Management, Process Improvement, Collaboration

Industry

Pharmaceutical Manufacturing

Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. MUST HAVE AT LEAST ONE YEAR OF DIRECT CENTRAL MONITORING EXPERIENCE**** The Manager, Central Monitoring is accountable for centralized monitoring activities for global and/or complex trials, analytical data review of key risk and/or operational performance data and presenting as an integral member of the Clinical Study team for clinical development studies. The reviews include interpretation of Key Risk Indicator (KRI) and/or Key Performance Indicator (KPI) data housed in an analytical tool as well as a comprehensive review of supplemental operational data/trends and issues to be interpreted, reported and presented to the study teams. The Manager, Central Monitoring, will be responsible for supporting several studies within a therapeutic area and program-level. They will work closely with other Central Monitors and Centralized Data Risk Analysts (CDRAs) to ensure effective identification, conduct and reporting of central monitoring activities. This role will contribute to continued process improvement and innovation activities, and industry collaborations in central monitoring capabilities. Collaborate on Study Quality Risk Assessment: Participate in the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT) to identify and manage study risks. Develop and Author the Central Monitoring Plan: Lead the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and Risk Based Quality Management (RBQM) methodologies. Oversee Central Monitoring Execution: Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system across assigned studies, ensuring effective signal detection. Analyze and Interpret Data Trends: Conduct study-level Central Monitoring Reviews using data analysis tools, interpret KRIs/KPIs, and assess trends to identify areas requiring intervention. Facilitate Study Team Decisions: Present findings to clinical study teams, support root cause analysis, and provide recommendations for follow-up actions to address identified risks. Document and Track Actions: Document outputs from Central Monitoring Review meetings, track decisions, and ensure timely closure of actions. Act as Central Monitoring subject matter expert. Represent Central Monitoring as a subject matter expert during audits, inspections, and within study teams on RBQM processes. Provide Oversight of Contract Research Organization (CRO) Activities: Partner with outsourcing management to align monitoring strategies and ensure CRO partners execute Central Monitoring activities according to the agreed standards. Drive Process Improvements: Evaluate the effectiveness of Central Monitoring processes, identify areas for improvement, and recommend enhancements to tools, metrics, and methodologies. Represent Central Monitoring in Initiatives: Represent the function in cross-functional process improvement initiatives and assess emerging technologies to enhance Central Monitoring capabilities. May require 25% travel JOB REQUIREMENTS: List knowledge, skills, and abilities required to perform the job. Strong analytical problem-solving and critical thinking abilities, with experience troubleshooting data refreshes and resolving execution errors in analytical systems. Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements Effective communication and interpersonal skills; ability to build relationships internally and externally Demonstrated ability to identify and interpret current and future business trends and apply them to centralized monitoring practices Excellent written communication skills, with the ability to convey complex technical and analytical insights in a clear and concise manner Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a focus on interpreting KRIs and KPIs Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures Proficiency in Microsoft Office applications, with advanced skills in Excel for data manipulation and reporting Preferred: Experience using CluePoints or similar centralized monitoring RBQM system. Minimal educational requirements: Bachelors Degree Required Licenses & Certificates: Minimum Years of Experience: At least 7 years of relevant experience in the biotechnology/pharmaceutical industry, with a minimum of 1 year with direct Central Monitoring experience. Site monitoring or data management experience a plus. #LI-LG4 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

The Manager, Central Monitoring is responsible for centralized monitoring activities for global and complex trials, including data review and presenting findings to clinical study teams. They will also oversee the execution of the Central Monitoring Plan and support process improvements.