M. Prateep

• Overall 12 global clinical trails with APAC, EMEA, US/Canada working as a Functional CML.
• Perform functional lead responsibilities for assigned project deliverables for certain smaller or less complex projects from start-up to final deliverables including closeout.
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed.
• Support CMS Team to oversee the finance related information in the study and provides inputs to EAC (provide accurate forecasting hours for Team members).
• Manage Investigators Payments Activity from set up to close out of the study.
• Contribute to the development and use of study management plans including Risk Assessment and Mitigation Plan and specific tools .
• Coordinate efforts of Cross Functional Project teams to support milestone achievements and to manage study issues and Obstacles.
• Support in managing project resources (CRAs/CTAs/Centralized monitoring team).
• Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and enable early identification of site[1]level risk/issue(s) and take appropriate action.
• eTMF: Maintain study related documents timely uploaded in the system and maintain Completeness, Quality, and timeliness. Always maintain the compliance.
• Vendor Management: Responsible to oversee the tracking of non-Investigational product (IP) supplies and equipment that are send to site and need to know how to manage non-IP in a study. Sites are equipped to conduct study as per the protocol and ensure these are used only for trials.
• Always coordinate with vendor Management timely supply/resupply of equipment’s.

1. Prepare i-Site Pack as per the project-specific requirements in the Clinical Operations Plan (COP).

• Establish and maintain effective Project site communications with relevant stake holders.
• Oversee IP Management for assigned global studies , Shipment tracking and Registrations, identify risk during transition and proposed mitigations.
• Review Protocol deviations and Record in CTMS for assigned studies.
• TMF management for documents on time filed in repositories and maintain Timeliness, Quality, Completeness.
• Perform Alerts management : Missing pages, open Queries, SDV backlog and Action Items.
• Conduct a call with Project Lead and Clinical Lead to provide the study updates for assigned countries.
• Monitored number of cases received and returned by employees on weekly, monthly, and quarterly basis.

• Manages the set up and maintenance of electronic Trial Master Files (eTMF), (Trial, Country and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Project Manager
• Leads the development, creates, and maintains of the eTMF Plan and TMF Index with Project Manager/Study Lead and/or sponsors
• Maintains the TMF in a state of audit readiness for quality and compliance by: 1
• Visual quality checks of e-documents prior to release to confirm image clarity and readability
• 2
• Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate
• 3
• Initiating the What’s Missing for all documents and ensuring full completeness of the TMF for each study, tracking and obtaining missing, incomplete, incorrect, inaccurate artifacts against the TMF Plan and study milestones
• Participates in client audits and regulatory inspections by providing guided access to the eTMF study area

• Mentor for PTMF team consisting of 10 Indexers and maintain Team Quality and Productivity and at the same time Individual Production & quality and Conduct the Team Hurdles and updates session and QC analysis sessions
• Complete the All trainings within timeline and Assure that all Team members also following the same
• Responsible for Indexing and issue mails processing
• Mailbox Administration: Categorization of IIP, and Priority & Non IIP and Issue mails from Mailbox
• Distribution of IIP and priority & Non IIP mails to indexers for processing
• As a Mailbox admin maintain the processing mails do not slip down to backlog stage

• Co-ordinate with PI, CRO and patients who are participating in clinical trials
• Maintaining all source documents According to ICH-GCP Guidelines
• Handling all clinical trial related activities comply with SOPs/Protocol/ICH GCP/Local and International quality and assigned projects, preparing for Inspections and audits held at the site
• Protocol & study related documents and Amendments submissions and Notifications during the study period
• Timely reporting of all adverse events (AEs) and serious adverse events (SAEs) to the Ethic Committees (IRB/IEC) and sponsor
• Good knowledge and clinical domain experience from start up to closeout processing of clinical trials at site level and Archival procedures
• Study drug destruction and other Laboratory and study related documents perform at site (if applicable)
• Projects done at Asha Hospital: Alzheimer’s Disease, Schizophrenia (Adults & Adolescent population), Major depressive disorder (Adults & Adolescent population), Generalized Anxiety Disorder, Bipolar1 Disorder, Opioid dependent patients, Juvenile Primary Fibromyalgia Syndrome, Bio-equivalence study in Schizophrenia various sponsors
• Worked with different Vendors as a study coordinator: I have experience in Paper CRF and e-CRF like Medidata, inform and, ORDC, Pheedit others
• I have 7yrs experience in taking ECG (QECG & eRT) for Study purpose
• I have also experience in IVRS & IWRS
• I have worked with Quintiles, Covance, PPD, ICON, QUEST diagnostics, SRL, Clinigene, Diagnosearch, Manipal Acunova Limited Laboratories
• I have Experienced in Audits which done by different sponsors and CRO’s
• I have Experience in FDA Audit which was held at Asha Hospital in May 2007 and October 2008