Mrunmayee Samant Email & Phone Number

Pune, Mh, In

India

India

Canton Usa

Leading data management projects and overseeing the data management tasks• Mentoring and training team members comprise of clinical data managers, data entry operators, research associates based in US and overseas subsidiary• Responsible for all data management deliverable including startup, conduct, closeout, documentation and archival activities of clinical trials.• Handling Database design and build, UAT, site trainings, Query management, Lab, eDiaries, Reconciliation activities for different clients.• Assigning Data Management responsibilities in Clinical system and ensuring timelines are met • Participating/Leading in study team and all related meetings for assigned protocols by providing data management insights and /status reports• Organizing client meetings to understand their requirements for the project• Developing study timelines for data management milestones in conjunction with the study team• Assist in the development and implementation of strategy for data cleaning, and in the design and programming of clinical data bases.• Review and approve draft of the Data Management Plan document including edit check specifications and CRF Completion Guidelines for a Phase I, II & III studies.• Implement and maintain Data Management Plans within local and overseas team• Review and approve CRF design and data base design according to standard operating procedures and protocol.• Review ,analyze and validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines,• Develop and maintain documentation and data management guidelines• Assisting with database lock and closure activities• Drafting UAT(User acceptance testing) & approving the system for implementation into production data base.• Drafting dummy data for edit checks and approving the programs for live runs. • Working with site, CRA and client to get all data accurately collected and SDVed on time to accelerate close out.

Involved in IRB Approval meetingsInstitutional procedures- SOP and Data management, Documentation of Adverse eventRegulatory activities – Protocol compliance, FDA, ICH-GCP regulationsMonitoring activities – Protocol Preparation, Case report form development, Initiation visits, regular visits with close out.Quality assurance and Quality check

Study Manager - Phase-III respiratory studies•Managing and guiding 15 members on 3 Phase III respiratory studies•Deciding on work distribution and deadlines of the study•Participate in protocol review and CRF design•Compose edit check specifications and test the test database•Query management•Preparing and reviewing data management plan and study documents.•Doing validation checks for the databases cleanup up till the database lock.•Assist development of annotated CRF•Reviewing the development of plan related to trial validation documents and approving final CRF design, validation checks and reports necessary to assure high quality and consistent data. •Writing and Testing Data Entry forms(Oracle)and Validation checks (SAS)Appointed as a Trainer and SOP co-ordinator-•For new employees on the software and the working tools, procedures and Data management activities.•Have prepared a matrix for the SOP and Guideline training

• Worked on 4 different studies on almost all the Data management activities.• Keeping track of the incoming CRF’s.• To carry out Data Entry as per project specific Data Entry Guidelines and Clinical Data Management Specifications (CDMS).• Removal of the discrepancies within primary and secondary data-entries via Compares program.• Tracking and filing of CRF/Lab Reports/ECG/CDCF as per project specific Data Tracking Guidelines.• Filing of Study related Documents

Worked as a Lecturer for under graduates in subject of - Physiology and Anatomy - Theory and Physiology and Biotechnology - Practical

Master Of Science (Ms), Clinical Research Administration, 3.75 Gpa

Master'S Degree, Physiology, General

Master'S, Physiology/Biotechnology

Master'S Degree, Animal Physiology