Anindita Hazarika

Tmf Lead @ICON plc

Bengaluru, IN

Responsible for the complete and accurate TMF through documentation of quality, consistency and timely filing across all assigned clinical trials.• Ensure that the clinical trial documentation is consistent with the TMF specifications, applicable SOPs, ICH/GCP guidelines, regulatory agency and any other local authority requirements.• Responsible that the TMF’s are submission/inspection ready• Lead the setup of the TMF Study Specific Document List (SSDL)• Monitor completeness and quality of TMF content for all assigned clinical trials until study close out.• Support documentation flow within projected timelines and determine course of actions to prevent and remediate delays and errors.• Serve as POC for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses.• Facilitate communication and interaction among study team members from the set up until the closing of the TMF for a clinical trial.• Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.• Maintain SSDLs at the study, country and site levels by collaborating with all relevant Functional Lines (e.g. DM, Clinical, Regulatory, etc.) to ensure placeholders are correctly and accurately in place for the study and all versions and instances are filed in a timely fashion.• Conduct periodic quality review of SSDLs at all levels and liaise with the Functional Line Document Owners to ensure that all findings are addressed and remediated in a timely manner.• Support Study Team to ensure document quality requirements are agreed to and met, according to Completeness, Timeliness and Quality metrics, and enforce ownership and accountability across study teams.• Ensure complete TMF is in place at time of study close/submission.• Mentor new employees in specified TMF Owner tasks and duties, if required

Assam (Central) University

Master of Science - MS, Botany/Plant Biology

Dibrugarh University

Bachelor of Science (B.Sc.), Botany

Assam University, Silchar

Master of Science (M.Sc.), LIfe Science (Botany) and Bioinformatics

Cliniminds

PG DIPLOMA, CLINICAL RESEARCH,CLINICAL DATA MANAGEMENT &SAS

Bioinformatics centre,Assam University

PG diploma, Bioinformatics