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The position of Central Monitoring Manager at Parexel is designed to enhance global health outcomes through innovative clinical development solutions. This role emphasizes the critical responsibility of overseeing centralized monitoring activities for complex global trials, ensuring high-quality project execution in line with industry standards. The candidate will be an integral member of the Clinical Study team, involved in analyzing risk indicators and operational performance data to support decision-making in clinical studies.
The Central Monitoring Manager will be expected to engage in a variety of essential tasks that drive the success of clinical development projects. Key responsibilities include:
Centralized Monitoring Activities: Overseeing and coordinating centralized monitoring efforts for various clinical trials. This involves the analytical review of Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs), alongside comprehensive operational data analysis to identify areas requiring intervention.
Collaboration on Quality Risk Assessment: Actively participating in the development of the Study Quality Risk Assessment & Control Tracker (QRACT), with the goal of identifying and effectively managing study risks throughout the trial lifecycle.
Central Monitoring Plan Development: Leading the creation of tailor-made Central Monitoring Plans that align with the specific requirements of each study, ensuring that best practices in Risk Based Quality Management (RBQM) are strictly adhered to.
Data Analysis and Interpretation: Conducting in-depth analyses of study data, enabling efficient interpretation of trends and signals that inform the study teams of potential issues or improvements.
Facilitating Decision-Making for Study Teams: Presenting data-driven findings to clinical study teams, guiding root cause analysis, and proposing actionable strategies responding to identified challenges.
Documentation and Tracking: Ensuring all decisions and action items discussed in Central Monitoring Review meetings are properly documented and monitored to promote accountability and timely follow-up.
Process Improvement Initiatives: Evaluating the effectiveness of current central monitoring processes and recommending innovative enhancements for future projects.
Oversight of CRO Activities: Working collaboratively with Contract Research Organizations (CROs) to ensure monitoring strategies are executed according to established standards, thereby enhancing overall project quality.
To be considered for the Central Monitoring Manager role, candidates must demonstrate the following skills and experience:
Direct Central Monitoring Experience: A minimum of one year of direct central monitoring experience in the pharmaceutical or biotechnology industry is essential. Candidates should possess at least seven years of overall relevant experience.
Analytical and Critical Thinking Skills: Strong analytical skills, critical thinking abilities, and a proven track record of troubleshooting data discrepancies in analytical systems are vital for success in this role.
Effective Communication Abilities: Capacity to convey complex technical content clearly and concisely is paramount. Interpersonal skills to foster relationships with internal and external stakeholders are also necessary.
Knowledge of Regulatory Guidelines: Familiarity with clinical drug development processes, including ICH and GCP guidelines, along with knowledge of regulatory requirements, is crucial for maintaining compliance throughout clinical trials.
Technical Proficiency: Proficiency in Microsoft Office, particularly Excel, is required for data manipulation and reporting. Experience with clinical databases and electronic data capture systems is also beneficial.
Educational Background: A Bachelor’s Degree in a relevant field is required for this position.
The provided text does not include specific salary details for the Central Monitoring Manager position at Parexel. Job seekers are encouraged to inquire about salary and benefits during the interview process.
Contract Type: This is a full-time position, indicating a stable employment opportunity with sustained engagement.
Location: The role is based in the United States, allowing the potential for remote work options, which is increasingly valued in today’s job market.
Travel Requirements: It may require up to 25% travel, thus candidates should be prepared for occasional travel associated with project needs.
Candidates applying for this position should prepare thoroughly by showcasing how their experiences align with the core responsibilities and qualifications outlined. Understanding the impact this position has on improving global health could also be beneficial for interviews.
Overall, this job offers the opportunity to work in a significative capacity at Parexel, a prominent organization in the field of clinical research, where one's contributions could lead to meaningful health outcomes worldwide.
This job offer was originally published on himalayas.app
This job offer summary has been generated using automated technology. While we strive for accuracy, it may not always fully capture the nuances and details of the original job posting. We recommend reviewing the complete job listing before making any decisions or applications.
