G P Email and Phone Number

Managing all study start up, maintenance and closeout site management responsibilities, under the supervision of the Clinical Trial ManagerLeading the maintenance of audit-ready clinical trial documentation and study status: manage and track regulatory documentation, IND Safety Letter distribution, Confidentiality Agreements and Clinical Trial Contracts.Set-up, implement and maintain the audit-ready eTMF system with minimal guidance Develop study specific processes to ensure that necessary study supplies are available at sites as necessary, coordinating with appropriate vendors as needed: (i.e., CRFs, Study Manuals, lab kits, drug supplies, lab supplies, etc.); manage review and tracking drug shipment destruction/returnManaging clinical operations site payments, prepare site invoices and supporting documentationManaging drug supply and non-drug supply study trackersAssisting with reviewing monitoring visit reportsCoach and mentor junior CTAsSupports the CTM or project manager with study start up and executionActs as a second point of contact between team members, vendors and study sites to assist with study conductFollows established clinical study standards and procedures to plan and conduct clinical research studiesRequests, collects and submits site documentsReviews study start up documents and disseminate to the appropriate functional groups (i.e. legal, regulatory)Coordinates IRB/EC submissions and tracking progress to review and approvalTracks study start-up statusSupports the establishment and maintenance of the study TMF. Prepare master Clinical Study Files and Trial Master Files for archiving and/or transfer to a clientSet-up and maintains study clinical trial management systemAssists in development of supportive study documents such as informed consent forms, monitoring templates, study subject tracking tools, study drug shipment and monitoring forms, study manuals and training materials, as required for a new clinical study.

Handled and supported in planning and execution of clinical studies, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelinesProvided clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Clinical Study Oversight Plan (CSOP)Prepared the study for inspection readiness which included updating the historical compendium on an ongoing basis, closing all the open queries and doing query resolution Reconciled the TMF document trackers with the document archive by bringing issues with the reconciliation to the attention of the Study Manager and proposed remediation plan Distributed key study documents to the CRO and vendors as appropriateProvided clinical administrative support to the study teams which included preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator MeetingsCollected information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov)Supported Fair Market Value process in evaluating study budgetsReviewed and documented reports, such as site monitoring trip reports and protocoldeviation reports and elevate issues to the attention of the supervisorCompiled and maintained CRO Oversight Monitoring (CROOM) visit output Compiledwhich included monitoring review spreadsheetPrepared the study to be Inspection Ready which included storyboarding of issues andprocessTracked study metrics such as site start-up, Investigator/site performance, recruitment,regulatory documents, TMF filing and QC activities and elevate areas of concern to yoursupervisor

Assisted Clinical Project Managers with updating and maintaining clinical databases (EDC) that track site compliance and performance within project timelinesAssisted in the development of ICF and their review with rapid study start-up, interim maintenance, and close-out activities to ensure study timelines and milestones are met Coordinated in preparation ICF, Clinical Trial Agreements and Preparation of CRFs Prepare, review, and submit submissions to ethics and regulatory and other relevant authorities to obtain necessary authorizations/approvals pertaining to the clinical trial conductSupported in management of electronic Trial Master File – Veeva VaultLiaised with Regulatory group to ensure completion and verify accuracy of Essential DocumentChecklists for drug release, including FDA Form 1572s and Financial Disclosures Analyzed and reviewed regulatory documents in compliance with ICH/GCP guidelines and Company SOPsCoordinated in distribution of site binderHandled the content of project Trial Master Files and ensure its accuracy and completeness, including paper files and/or an electronic Trial Master File (eTMF)Ensured compliance with the patient-consent process and verified investigator records and performed quality checks to ensure consistency with the contents of sponsor files Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolutionDeveloped and finalize Country Specific SIS/ICFsManaged study material distribution and receipt at appropriate stages of the study Worked with Safety team on management of SAEs and assist with follow-up activities along with creating agendas and record team meeting minutes under the direction of the Clinical Trial Manager

 Maintained record information of the vital signs (pulse rate, temperature, blood pressure, weight, height) in the Electronic Medical Record Assisted in Screening, consent, and enrolling subjects according to rules, regulations, and procedures outlined in the protocol and approved by IRB Performed document control process duties which includes operations of editing, reviewing, tracking, and issuing documentation as per applicable Standard Operating Procedures (SOP)

Head of a cultural committee where my responsibilities included organizing, managing and coordinating various events

Social Responsibility Forum of SVKM’S NMIMS SPPSPTM, responsible for conducting various events like health awareness campaigns, Street plays promoting Organ Donation, free health checkup camps for the underprivileged and AIDS Awareness Marathon, Osteoporosis Camp etc.

• Inspected and reported Medication Error Reports and Prescription auditing. Also, conducted presentations and negotiations to healthcare providers as needed.• Delivered drugs at the out-patient and in-patient pharmacy and managed stock which was shipped from different stakeholders• Assisted in project management responsibilities for National Accreditation Board for Hospitals & Healthcare Providers which included scheduling meeting and coordinating the project status to vendors and sponsors.