Snehal Amol Jagtap

To excel in my area of activity by taking up challenging assignments, own skills by maintaining a learning attitude and contribute to the organization development with personal growth.

• Syntel Champ
• Multiple appreciations from Client
• SPOT Award
• Titan Award
• Syntel Speed Award
• High Accuracy for QC - 99.7%
• Multiple appreciations regarding work and commitment.

• Regulatory Publication
• Records Management
• Centralized Monitoring

• Certification in Clinical Research from Clinovision, Pune.
• Certificate course SAS from techData Solution.
• Attended National Conference of IPC, Ahmedabad, Gujarat.

• Date of Birth: 03/01/89
• Gender: Female
• Marital Status: Married

• TMF Support Associate 2, TMF Support Associate 2-TST, TST, Works independently with internal staff in the Wingspan placeholder management and issue resolution or other support activity, when applicable., Will be responsible to complete work to timeline expectations for assigned projects., Documents project challenges and communicates them to TMF Support Team Manager., Will be required to understand, with minimal support, budgets for the studies they are assigned to and maintains accountability for staying within budget., Will be required to understand, with minimal support, what tasks may be out of scope TMF Support Team activities and to understand that such activities do not begin until the client provides authorization, if applicable., Out of Scope activities will be communicated to the TMF Support Manager., Maintains open line of communication with TMF Support Team Manager to obtain necessary clarification throughout the assigned trials, if required., Attends TMF Support Team meetings, as scheduled., Keep training in a current state, as assigned., Maintains timesheet in a current state., Performs other duties as assigned.
• TMF Support Associate 2, eTMF Analyst, MoVE IT, Infolink, Wingspan, Veeva Vault, Provide Trial Master File (TMF) related assistance to study teams., Provide subject matter expertise on key source systems and operational processes to drive the system compliance., Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics., Work in tandem with project team and other stakeholders for timely initiation of eTMF and contemporaneous management of eTMF., Ensure that project timelines are met and facilitate the orderly transfer, retention, and disposition of various project-related and business records., Establish and maintain effective internal and external client communications., Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs., Process audit notifications to global stakeholders., Support eTMF closures to meet final eTMF delivery to sponsor., Adhere to timelines as per SOP for eTMF setup and closure activities., Complete eTMF related activities manage escalations to help setup/deliver quality eTMF., Responsible for TMF and EDC archival related activities., Responsible for purging activity for the study once the TMF is archived.
• Record Management Associate, Trial Document Manager, MS Office, Doc check tool, ISI Tool box, Intralink, Communicating with client and respective CROs (Contract Research Organization)., Study start up and close out activities., Checking whether the document is according to template and client guidelines (checklist) or not and reconciliation of study., Maintaining technical quality of project and study level documents like CSR, PSUR, DSUR, IND and NDA before the Regulatory submission., Checking the eCTD name of Documents and suggesting authors on same., Checking links and bookmarks whether are they created by Inherit zoom or not., Sending errors to the authors and publishers via tool and helping them to resolve those., Helping publishers to publish documents and guiding them to release error-free documents., Helping Regulatory team to finalize the documents., Check the technical quality of eCRF’s from EDC trials., Provide Guidance to the authors on eCTD naming convention, formatting, meta data tagging., Ensure the quality of clinical and regulatory documents in the Documentum before releasing them for submission to the regulatory authority., Team Handling.