Naveen Kommajyosula Email & Phone Number

Pickering, On, Ca

Greater Toronto Area, Canada

• Manage all clinical operational and quality aspects of allocated studies in compliance with ICH GCP in role of Global Lead CTM.• Developed clinical tools and collaborated with the clinical team and other departments as needed to meet deliverables of the project. • Regularly communicated with the team and led team meetings to ensure that timelines, resources, interactions, and quality are maintained. • Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. • Ensured achievement of the major clinical deliverable on or before the contractual time period specified, by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, and reviewing monitoring visit reports.• Communicated with Investigators and study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.• Currently coordinating all start-up activities and ensuring that essential document quality meets the set expectation.• Regularly prepare and update forecast estimates for clinical activities while managing clinical resources.

Greater Toronto Area, Canada

• Conduct site visits to assess protocol and regulatory compliance and managing required documentation• Responsible for ensuring that data will pass international quality assurance audits• Develop and maintain collaborative relationships with investigational sites and client company personnel• Lead and developed tools for remote analysis of the data• Assist project manager or clinical team managers on assigned projects.• Perform remote monitoring in a planned and effective way to identify risks to ensure better compliance and early risk identification• Proactive site management and create reports to assist Manager and trial team to create metrics• Perform SDV and identify deviations during onsite and remote monitoring.• Create listings from internal systems and vendor systems. Perform review of listings at study level.• Perform site initiations, monitoring and close-out. Training site personnel on an ongoing basis to ensure compliance to protocol

Greater Toronto Area, Canada

Conducts site visits to assess protocol and regulatory compliance and manages required documentationResponsible for ensuring that data will pass international quality assurance auditsRepresents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnelMay assist project manager or clinical team managers on assigned projects

Bengaluru Area, India

• Analyzing the data using combination of tools and analytical techniques to detect, investigate, diagnose, and mitigate risk within clinical trials more efficiently and accurately from a global perspective. • Identify potential risks and proactively suggest mitigations for timely action.• Responsible for analyzing operational and patient clinical trial data to identify and characterize issues and trends that can be indicators of project risk. • Helping to blend an analytic approach with cross-function operational knowledge to evaluate and communicate issues to the appropriate functional team members for further investigation and resolutions. • Serve as an advocate for early risk mitigation and corrective action by reporting and effectively communicating across global business units' project data risks.

Hyderabad Area, India

• Providing Central Monitoring services to Novartis Healthcare Pvt. Ltd• Managing global trial liaising with all the line functions involved• Reviewing eCRF data on an ongoing basis and raising clinical and medical data queries. • Identifying regular trends and patterns to provide inputs regarding the quality of trial data• Help in improving the data quality by performing continuous central monitoring and timely escalation and resolution of queries.• Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines. • Establish and maintain good rapport with study team and field monitors. • Write study visit reports within the timeline established by applicable SOPs• Communicate site study issues, concerns, and progress to Project Manager, Clinical Team Lead, and Clinical Research Manager. • Develop and implement corrective actions when appropriate. • Conduct and assist with administrative activities as a member of the project team and Participate in routine study progress meetings.

Developing trial protocols (outlining the purpose and methodology of a trial);Presenting trial protocols to a InvestigatorsDesigning data collection forms, known as case record forms (CRFs);Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;Locating and assessing the suitability of facilities at a study centreLiaising with doctors/consultants (or investigators) on conducting the trialSetting up the study sites, which includes ensuring each centre has the trial materials and training the site staff to trial-specific industry standardsMonitoring the trial throughout its duration, which involves visiting the study centres on a regular basisVerifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);Writing visit reportsFiling and collating trial documentation and reportsEnsuring all unused trial supplies are accounted for

Bengaluru Area, India

Ensuring high levels of accuracy, manage and maintain clinical study documentation and coordinate the ordering, dispatch and tracking of study materials. Support the project teams by updating the Clinical Trial Management Systems.Arrange and attend internal and external meetings, helping to produce presentation materials and generate meeting minutes. Assist in the tracking and distribution of safety reports and coordinate document translation if required. Contacting external and internal individuals.Collate relevant study information and assist with study payments. Involvement in managing Meetings when requiredMaintain & Update the study files.

Master'S Degree, Biotechnology

Advanced Pg Diploma, Clinical Research And Cdm

Bachelor'S Degree, Biotechnology, Chemistry

Ssc, Math, Science, Social