Senior Centralized Monitoring Lead

Senior Centralized Monitoring Lead #lifesciencegraduate #nagpurjobs #apportunities #clinicalresearchinstitute #smo #clinicalresearchcareers #clinicalresearchtrials #medicalresearch #healthcare #biology #pharmacovigilance #clinicalresearchtraining #education #bpharma #research #clinicalresearchers #nurse #clinicalresearchjobs #crc #pharmaceuticals #pharma #clinicaltrialsguru #clinicaldatamanagement #cralife #sciences #pharmacy #training #careers #rn #clinicaltrialsday The Centralized Monitoring Lead would be collaborating with the Sponsor Central Statistical Monitor and Clinical Study Team to understand the study data and risk reports using available technology to monitor data quality, patient safety and relevant risks, he/she would be the first poc to draft any study related risk/issue(s) and maintain the Risk Management Plan and tools. This role will be involved early in the protocol development process to support risk identification, risk assessment, finalizing quality thresholds/triggers and risk action planning as well. This will be in close collaboration and ongoing discussion with the clinical study team. The CML will play a vital role in the Risk-Based Quality Management process and is a key driver to facilitate the RBM process as a subject matter expert and change champion. General Description: The Clinical Operations Excellence Organization is a sub-function under Global Clinical Operations responsible for driving and monitoring compliance, performance metrics, process improvements (processes and procedures), Training, and Risk Based Monitoring. This role will focus on supporting RBQM process improvement initiatives across Global Clinical Operations and will work with the RBQM Leadership Team. Primary Responsibilities Collaborate with the assigned Central Statistical Monitor to interpret analytical dashboard, establish correlations between analytics and essential study documentation (Protocol, CRFs, data transfer specification etc.) and perform root cause analysis in collaboration with the clinical and cross-functional teams. Facilitating early risk/issue(s) identification with collaboration of the Central Statistical Monitor and clinical study team and responsible for identification of risk alerts, timely escalation of risk/issue(s) to relevant stakeholders (e.g., study manager, on-site monitors/CRAs) and tracking of risk/issue(s) and actions until resolution. Collaborate with the Central Statistical Monitor for a coordinated and ongoing/periodic monitoring of patient data and site data centrally using available technology/platform for multiple studies to ensure high data quality and patient safety. Platforms/risk mgt tools include but are not limited to CTMS, Risk Assessment system (CluePoints 2.10 and/or TriTrials OPRA 5.0); eCRF/ EDC/RAVE, IRT clinical drug supply system, etc. Monitoring and knowledge sharing of risk reports, data trending related to quality, safety, efficacy (effectiveness), and site performances generated by assigned Central Statistical Monitor s analytics and visualizations derived from the risk management tool/platform and customized predictive modeling to the clinical study team members. Keeping track of site performance and helping on-site monitors/study managers plan timely and appropriate corrective actions. Act as a single point of contact for relevant stakeholders (Clinical Study Team, Central Statistical Monitor, on-site monitors, COM/CTOM, safety/medical monitors, data managers, etc.) for their assigned studies and ensure timely communication and coordination of RBQM activities with these stakeholders. Collaborate with CTOM/COM/Regional COMs and on-site monitors to ensure they are well equipped with the details of site related risk/issue(s) to plan timely site intervention (site visits or telephonic contacts with sites) and to ensure more efficient and focused activities during monitoring visits. Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities e.g., risk/issue(s) findings, escalation, tracking and resolution during appropriate phases of the study utilizing the RBQM tools such as but not limited to IQRMP, Risk Management Plan, and RACT tools maintained within the vendor platforms in accordance with the Sponsor RBQM SOP. Facilitate study team risk management review meetings with the relevant clinical team stakeholders needed for tracking/controlling of risk/issue(s) through issue resolution- this includes trending of risks and issues seen across the CML s assigned study allocation. Supporting the RBQM team in optimizing the RBQM model as a change champion and subject matter expert for a risk-based environment including but not limited to participation in RBQM team meetings for trends analysis and sharing, newsletter content creation, RBQM website maintenance for knowledge sharing, facilitation of RBQM info sharing sessions, and various RBQM lunch-n-learn training sessions. Support RBQM Team with providing assigned clinical study teams with onboarding training and tools to aid in the adoption of the RBQM approach. Supporting the RBQM team and clinical study teams in optimization of Source Data Verification/Source Data Review processes to help reduce on-site monitoring visits overall for the studies as outlined in the study specific Risk Management Plan Support Center of Excellence/RBQM team in building overall efficiencies in clinical trial operations by applying lessons learned and trend analysis sharing from RBQM pilot experiences with the GCO leadership. Preferred Background/Qualifications 5-7 years comprehensive experience in clinical monitoring, clinical data analytics and/ or data management activities. Ability to work independently to drive RBQM activities as a change champion, keeping the teams on track to risk management and oversight activities. Excellent communication and coordination skills strongly preferred with experience working and communicating within cross-functional teams. Knowledge of overall clinical trial management process, understanding of the protocol, study associated risks and their significance in monitoring the clinical study. Critical thinking and analytical skills to understand/ analyze complex data and provide insight into risk reports, trends, and outliers in data. Therapeutic area specific experience and knowledge Oncology/Hematology preferred. Technical ability to use the relevant technology and risk-based tools/platforms effectively.