بريانكا هارداس

Responsible for handling Clinical Studies of therapeutic areas like Gastrointestinal, Respiratory and Oncology

Responsible for performing all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role.
Involved in data validation activities, generation and integration of queries.
Reconciliation of safety and electronic data (IVRS, Labs, Diary and ECG) and updating data correction form.
Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines, etc.
Conducting in house data review (Working on offline listings).
Generate and close queries or apply self-evident corrections to the data according to the relevant guidelines.
Identify and report Protocol Violation and Protocol Deviation Queries
Handling Manual and Patient profile review, issue queries.
Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action.
Acquiring Track and integrate queries and QC activities.
To perform activities like D Review, Form Freezing, and sending request for PI Signature.
Update all relevant Tracking System on an ongoing basis and do the effective follow up for the same.
Inform responsible CDA Coordinator of work status regularly.
Currently working on study close out activities pertaining to the data management for a study.
Working on EDC tool, DataLabs
Ensure that the priority study terms are processed on priority.
Ensure adherence to Productivity and Quality targets.
Achievement- Received Appreciation Certificate from Assigned Project team for Hardwork, Productivity, Quality work and achieving timelines. Recognized as High Performance Cultured Team member in Parexel International’s News Letter of May 2014.

Involved in the Clinical Studies of therapeutic areas like Respiratory and Cardiovascular as a SPOC and team mate

Worked on various set-up and conduct activities pertaining to the data management for a study.
Responsible for the creation of Data Handling Plan, Edit Checks document, eCRF Completion Guidelines and Study Plan Specifications.
Performed User Acceptance Testing (UAT) for the screens and the edit checks in OC-RDC and OC classic.
Performed data reconciliation including the external data (Lab data, Diary data, ECG and IVRS etc.).
Creation of Vendor agreement document for the external data and the data transfer and loading.
Performed data reconciliation for Pharmacokinetics and Pharmacogenetics studies.
Handled teleconferences with Clinical Data Scientists and preparing Agendas and Minutes of Meeting for the same.
Prepare the Weekly Metrics for the study.
Achievement- Received Appreciation Certificate from Assigned Project for Outstanding delivery focus, collaboration and excellence.

Detailed presentation regarding stem cells and its uses and explaining the stem cell banking technology to the expecting parents.
Enrollments for stem cells banking.
Arranged and conducted Antenatal sessions in accordance with the gynecologists.
Exploring new functional areas.
Responsible for providing the detailed weekly report and metrics regarding the Business Development activities, desired targets, Targets Achievements and forecast of next week’s activities and action plan to achieve the same