Sovan Das Email & Phone Number

Florida, United States

West Point, Pennsylvania

-Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned vaccine program-Support the project management of al clinical data management activities using excellent interpersonal, negotiation, and project management skills to assist with: project planning, risk management identification, meeting customer/stakeholder expectations - Participates and manages trial-level data quality and completion of database lock and post database lock activities

West Point, Pennsylvania

-Performs Sponsor Data Entry as applicable per data management plans following entry guidelines.-Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under-Runs data integrity check reports in accordance with data review plans and relevant SOPs.-Responsible for the execution of user acceptance testing of data management tools -Escalates overdue items, including but not limited to outstanding questions and missing visits.-Maintains compliance with standard key performance indicators according to process expectations at the protocol level.-Monitors data quality and cycle-time performance measures to maintain compliance, performs root cause analysis and implements action plans as needed.

In Merck Research Labs within the Operational Excellence area of the Global Data Management and Standards (GDMS) team. Assist in documentation management compliance for clinical trials, metric tracking and presentation for quality and compliance milestones as well as support ad hoc OE initiatives.

-Helps the pharmacists provide medication and other health care products to patients and consumers. -Perform routine tasks to help prepare prescribed medication, such as counting tablets and labeling bottles.-Dispenses specialty and injectable medications-Assists in sorting and filling of prescriptions, some data entry, stocking of medications and various related duties.

The Stress and Repair Drug Metabolism and Pharmacokinetic department within GSK's R&D is responsible for characterizing the discovery/pre-clinical drug metabolism and pharmacokinetic profile of new small molecules. My responsible is to assist in the conduct of drug metabolism and pharmacokinetic (DMPK) studies that will support the discovery program. Along with sample preparation, analyze drug levels in biological samples via LC-MC/MS, in vitro metabolic clearance assays along with data analysis and report generation.

In the Global Regulatory Affairs and Clinical Safety (GRACS) Quality & Compliance department, I investigate and remedies quality and compliance issues. Also, helps facilitate audits and inspections. In addition, the provide consultation to the larger GRACS community on quality and compliance matters in an effort to reduce instances of non-conformance. Supports the team by developing a training plan for the group, monitoring regulatory commitments, conducting investigations, and assisting with Corrective Action/Preventative Action (CAPA) management work.

-Sets-up and operates various scientific apparatus; sets-up and operates spectrophotometer, centrifuges, incubators, homogenizers, and various microscopes.-Assists with research projects; prepares and maintains culture media, reagents, and experimental animals; grows cultures; sterilizes equipment; separates and purifies various materials and substances using such techniques as chromatography and electrophoresis; prepares compounds; interprets experimental test data; performs minor equipment repairs; cuts, stains and mounts specimens.

-Assistant to the Physician, performing documentation in the EHR-Accompany physician into the patient examination room in order to transcribe a history and physical exam, and document accurately the physician’s encounter with the patient and others present. -List all proper diagnoses and symptoms as well as follow up instructions and prescriptions as dictated by the physician.