Joydeep Debbarma Email & Phone Number

Hyderabad, Tg, In

Hyderabad, Telangana, India

Hyderabad Area, India

Performing continuous remote monitoring/review/management of data under risk based monitoring (RBM) platform for Novartis global clinical trials using online data sources(like J review, RDC, Risk Analysis Tool, CMAT, Spotfire etc.) to review patient data for consistency, plausibility and completeness and identifying trend, pattern and risks at patient, site and country level. Working on early identification of potential risks, safety and/or quality issues and triggers which require follow-up actions.Discuss the key risks in protocol with CTT (Core Clinical Team) and feed inputs to KRI (Key Risk Indicators) and/or MP (Monitoring plan) as appropriate.Contribute in development of monitoring plan & central monitoring plan along with preparation of related monitoring tools/logs (study tools)Contributor for Mock CRF design and perform UAT (User Acceptance Testing) testing of EDC.Review and provide comments on Ready to Go (RTG), data monitoring plan (DMP), Data review plan (DRP) including PD checks and CRF completion guidelines.(CCG)Create and archive central monitoring report (CMR) in CREDI on monthly basis.Work closely with the other stake holders of the trials for exchanging the clinical or safety related observationsInteract with other stake holders of the trials.Train the field monitors (FM) on the monitoring plan.

Thnae

Site MonitoringEnsured all assigned studies follow applicable SOPs, GCP and local regulations.Ensured all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current.Performed site qualification visits, site training, participate in/conduct investigator’s meeting and site initiation visits. Performed regular monitoring visits to site and data and maintain audit readiness at the site level.Ensured clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements. Ensured site level metrics (i.e. 100% IP accountability, 100% informed consent documentation etc.) are tracked and communicated as appropriate.Evaluated the speed of recruitment and propose alternative solutions if the predefined objectives are not met, either in the terms of patient number or timelines. Resolved all data queries or other study related queries from the site within time frame. Conducted site close out and assure appropriate archival of controlled documents. Reviewed research protocols and amendments, informed consent documents, case report form and/or other applicable business and project related documents to provide the feedback for modification/altercations if any. Issue ResolutionResolved issues as they affect clinical plan timelines and quality to ensure achievement of goals and objectives at the site level.Ensured proper escalation of site/project related issues. Provided training to site members related to trial requirements like therapeutic area, protocol, CRF completion guidelines, Investigational product handling lab sample handling etc.Maintained regular contact with study sites to ensure protocol/GCP compliance and kept motivated the investigators in order to achieve recruitment targetsAssisted the project managers for the smooth conduct of Investigator meetings by preparing of presentations, liaising with participants, problem resolutions and follow up.

Bangalore

I have supervised and coordinated clinical trials by offering overall operational support to ensure adherence to GCP and maintain quality standards in accordance with ICH-GCP, declaration of Helsinki, applicable regulations, guidelines and study protocolPerformed pre-trial activities, initiation, monitoring, documentation and reporting of clinical trial sitesPerformed planning and review of task schedules for trials with inputs from the study team. I have provided assistance for recognizing, choosing and managing responsible parties such as CROs/vendors/any other parties for trial completion.I was involved in Planning and discussing of timelines for the trials. Ensured that CROs /vendors/any other parties as well as internal study team members perform necessary activities for successful completion of the trials.Liaised with medical monitor, internal colleagues involved in the study, CROs, investigators, suppliers and any other vendors as and when required.Prepared and presented study presentation at scheduled internal or external meetings.Ensured that the projects are on or below budget by reviewing and verifying study expenses through invoices received for the study. Supported in the development, designing, writing and review of clinical trial protocols, informed consent forms and other essential documents of the trials.. Ensured the proper documentation for the trials and ensured the precision and quality of regulatory data.I have supported the team in making vital decisions regarding assigned trials/projects by identifying impending obstacles, information analysis providing solutions to challenges.Maintained regular contact with study sites to ensure protocol/GCP compliance and keep motivated the investigators in order to achieve recruitment targetsKept a track and communicated the progress of study and relevant information like deviations/violations to project managers and other project team members on timely manner.

Bangalore

Assisted the project managers for the smooth conduct of Investigator meetings by preparing of presentations, liaising with participants, problem resolutions and follow up.Evaluated the speed of recruitment and proposed alternative solutions if the predefined objectives are not met, either in the terms of patient number or timelines.Prepared study centers, which includes ensuring each center has all the required trial materials and ensured timely submission of protocol/consent documents for EC/IRB approval.Performed site initiation visit and trained site staffs to trial-specific requirements and CRO's standards.Performed on-site clinical monitoring which included; document review, ensuring accurate data recording, verifying patient data, adherence to the protocol of a clinical trial in accordance with GCP/ICH guidelines and CRO & Sponsor’s SOPs.Ensured clinical trial supply are appropriately handled and adequately maintained at the site as per the project requirementsEnsured site level metrics (i.e. 100% IP accountability, 100% informed consent documentation, 100% source data verification etc.) are tracked and communicated as appropriate.Resolved data queries or other study related queries from the site within timeframe.Ensured all regulatory submission as per timelines and to ensured regulatory documents are available, complete and currentMaintained the accountability of Investigational product & clinical/non-clinical supply at site. Ensure the correct storage of drugs at Site.Maintained regular contact with study sites to ensure protocol/GCP compliance and keep motivated the investigators in order to achieve recruitment targets..Maintained all files and documentation pertaining to studies; preparing visit report, deal with CRF queries in timely mannerConducted site close out and assured appropriate archival of controlled documents.Prepared and submitted site visits report on timely manner.

Bangalore

- Ensuring the clinical trail goes on as per ICH-GCP and study protocol. - Preparation & subsequent submission of study related documents to the Ethics committee for approval. Reporting SAE to the Ethics committee.- Filling Case Report Forms( Electronic and manual)- Randomization of patients through Interactive Voice Response System (IVRS). - Maintenance of logs: Patient enrollment log, ECG log, Patient screening log, Drug accountability log and Deviation log. And proper documentation of clinical trials. - Research accountability distributed across pre-study, study implementation & study completion; with key responsibility to assist the Principal Investigator (Doctor) with conduct of a clinical trial.- Also serve as the primary link between the study team at site and monitor (CRO)

Bangalore

Served as liaison to the medical/scientific community, responsible for establishing, developing and maintaining relationships with doctors for achieving the sales target.Liaised with all sales team and all associated vendors for smooth availabilities of the drugs to every sales point.Conducted, coordinated and arranged Continuous Medical Education (CME) programs and Campaigns for the doctors.Have done drug detailing for Molecules like Cefadroxil, Azithromycin, Esomiprazole, Domperidone, Clonazepam, Escitalopram, Itopride, Cefixime, Racecadotril etc. to the doctors to generate prescription.Served as a successful link between the doctors and the company.Maintained highest degree of discipline, Integrity and punctuality.Established excellent reputation with the doctors and chemists and also with stockiest.Supported product pre-launch, launch and post-launch activities and communication plans as per organizational strategy and tactical plans.

Masters In Pharmacy, Pharmacology, 8.3

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, 1St Class