Job Description

Job Title: Central Monitoring Manager Job Location: India (Remote) Job Overview: The Central Monitoring Manager (CMM) executes and manages the Centralized Monitoring and Data Surveillance through Risk Based Quality Management (RBQM) for assigned clinical trials following applicable regulations, standard operating procedures, and work instructions. Range of tasks includes participation in the integrated data review process, creation of Central Monitoring and Surveillance Plan (CMaSP), reviewing data trend analysis, and tracking of actions taken to investigate or mitigate risk. The CMM is responsible for proactively identify issues and emerging risks in study-specific variables (such as trends or outliers) through the review of aggregate data and suggesting corrective and preventive actions when indicated. The Central Monitoring Manager reports to the Director, Central Monitoring & Surveillance. Job Duties and Responsibilities: Participate in the cross functional study team development of the Risk Assessment Management Plan (RAMP) and integrated data review planning. Generate Central Monitoring and Surveillance Plan (CMaSP) to document central monitoring activities and assist the study team in review of planned key risk/performance indicators (KRI) and quality tolerance limits (QTL). Provide technology vendors with required data transfer and study specifications for any central monitoring platforms. Determine required dashboards for central monitoring activity and perform user acceptance testing with any required technology. Perform and document the central monitoring of study data through periodic review, interpretation, of aggregate data against defined KRI and QTL. Lead a review of the central monitoring output with study team members and recommend corrective actions for risk mitigation as described in the RAMP. Track effectiveness of risk mitigation actions over time with study team members and provide escalation or additional recommendations if needed. Create and maintain relationships with relevant internal departments, study sponsors, and with external CRO vendors, as directed, to ensure quality data in clinical trials through management of key risk/performance indicators and quality tolerance limits. Manage the daily activities of the RBQM trials in accordance with Caidya (CP) SOPs and Good Clinical Practice. Maintain relevant project documents and file required documents in the trial master file (TMF). Attend regular team and client meetings, as requested. Attend investigator meetings and provide support, as requested. Participate in audits, as requested. Participate and provide content for bid defense presentations, as requested. Makes recommendations for improvements and contributes to the ongoing development of the CP RBQM Model. Contribute to the education and knowledge of RBQM processes across the organization. Demonstrate adaptability. Other duties as assigned by Director, Central Monitoring and Surveillance as relevant to the RBQM process at Caidya. May provide work direction to members on a cross functional project team. Supervisory Responsibilities: No supervisory responsibilities. Job Requirements: Education Bachelor\'s degree or higher, preferably with a data analytics, data science, or life science degree Experience Minimum of 4 years of experience in Central Monitoring or relevant experience Minimum of 6 or more years in Clinical Trials experience (e.g., Clinical Operations, Data Management, or other relevant clinical development activities) in the pharmaceutical or CRO industry Skills/Competencies Strong written and verbal communication skills including good command of English language Leadership skills of collaboration, listening, and directing others Advanced analytical/problem-solving skills/judgement in decision making Mastery of the ability to identify risks and data trends Demonstrate advanced proficiency in understanding and use data analytic software Strong computer skills, including Microsoft Office, including proficiency with Excel Advanced understanding of clinical research operations Advanced understanding of clinical trial data, including listings and summary metrics Basic understanding of statistical analysis High level of competency in exercising judgment within defined procedures and practices and to determine appropriate action independently Strong familiarity with Electronic Data Capture systems Able to work without direct supervision Ability to delivery results on time Ability to manage competing priorities Ability to work across cultures and geographies with understanding of cultural differences Strong interpersonal skills Comprehensive knowledge of GCP/ICH guidelines

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