- CDISC SDTM Data standard conversion and SME support- People and project Management- Streamline SDTM process

- SDTM eCRF Annotations- SDTM Metadata Development- SDTM Data Review & Validation using P21 checks- SAS Programming- Trial Design Domains review & development- SDTM Trainer

# Project Management of Clinical Operations: Providing solid leadership in building effective, high performing Data Management Teams through influence, integration, motivation and optimizing team performance which has ensured satisfactory progress of project work and timely resolution of issues.# Brainstorming and strategizing new training benchmarks in operational techniques within Clinical Data# Management Unit to ensure development and maintenance of team training plan is… Show more # Project Management of Clinical Operations: Providing solid leadership in building effective, high performing Data Management Teams through influence, integration, motivation and optimizing team performance which has ensured satisfactory progress of project work and timely resolution of issues.# Brainstorming and strategizing new training benchmarks in operational techniques within Clinical Data# Management Unit to ensure development and maintenance of team training plan is up-to-date and undertake training related to project# Monitoring Performance efficiently and effectively by defining and tracking SLA’s/Metrics on a project basis and meeting desired level of customer satisfaction benchmark in terms of quality deliverables # Coordinate and communicate effectively with primary contacts at Client teams to ensure satisfactory progress of project work and timely resolution of issues.# Strategic planner, able to align resources, staff, processes, and services to meet the needs of customers # Adept at developing and coaching teams to excel; improve overall cohesiveness and productivity and effectively collaborate with all levels of an organization.# Perform goal settings and Annual Employee Performance Evaluations# Participates in engagement level risk review meetings# Work in close collaboration with Manager-Operations, Director-Operations & service delivery unit heads to establish account as operational Centre of excellence through initiatives driven by functional expertise, core competency development, training & compliance, client engagement & offerings and contribute in individuals, business and overall organizational growth# TPV data SME, Data extractions & data merging using SAS Show less

# Coordinating, managing, relationship building and becoming a successful interface between the Data management team and internal/external customers, Leading operations team and ensuring quality of day to day service delivery. # Provide assistance to SAS team in terms of format specification and data conversion as per sponsor requirement. PK data merging with CRF data during DB lock# Owning third party processes and steps towards standardization# People… Show more # Coordinating, managing, relationship building and becoming a successful interface between the Data management team and internal/external customers, Leading operations team and ensuring quality of day to day service delivery. # Provide assistance to SAS team in terms of format specification and data conversion as per sponsor requirement. PK data merging with CRF data during DB lock# Owning third party processes and steps towards standardization# People management# Create quality and productivity matrices Show less

(1) Act as a bridge between the Third Party Vendors, sponsor point of contacts and the offshore Data loading team to ensure smooth data transfers and contract set ups(2) Maintain quality and timeliness of assigned project work(3)Use project management software like MS-Project to plan the data management deliverables and propose the timelines for clinical studies. Also, responsible for planning the validation activities in detail for systems like IVR/IWRS and ePRO(4) Accountable for… Show more (1) Act as a bridge between the Third Party Vendors, sponsor point of contacts and the offshore Data loading team to ensure smooth data transfers and contract set ups(2) Maintain quality and timeliness of assigned project work(3)Use project management software like MS-Project to plan the data management deliverables and propose the timelines for clinical studies. Also, responsible for planning the validation activities in detail for systems like IVR/IWRS and ePRO(4) Accountable for successful integration of systems like IVRS/IWRS and EDC (Medidata RAVE)(5) Ensure data transfer specification are reviewed and finalized by stakeholders as per agreed project plan.(6) Setting up and maintaining contracts with 3rd party vendors along with providing transfer and load specifications(7) Monitor status of data transfers, manage risks and issues with the third party provider(8) Provide expertise to client study team regarding third party data handling processes when working with collaborative groups(9) Provide inputs to the Study Team for creating User Requirement Specification(URS)(10) Perform user-acceptance test (UAT) prior to FSI to ensure that the data transfers meet all specifications.(11) Gathering project information and planning for validation deliverables(12) Review of all validation documents, if required(13) Suggesting and contributing for process improvements as appropriate(14) Extensive working experience in different European (CET) and US (EST) time zones to ensure time overlap and facilitate better communication with client stakeholders. Show less

(1) Setup of "Data Transfer Specification (DTS)" with different third party vendors as per study requirement.(2) Involved in review of DTS and data loading as per data transfer specification and as per sponsor requirement(3) Ensure UAT of test data before Commencing production data transfer(4) Ensure data being loaded correctly and necessary action to be taken whenever required(5) Involved in review "User Acceptance Specifications (URS)" along with study team (6) Create… Show more (1) Setup of "Data Transfer Specification (DTS)" with different third party vendors as per study requirement.(2) Involved in review of DTS and data loading as per data transfer specification and as per sponsor requirement(3) Ensure UAT of test data before Commencing production data transfer(4) Ensure data being loaded correctly and necessary action to be taken whenever required(5) Involved in review "User Acceptance Specifications (URS)" along with study team (6) Create Validation Plan, Test Plan, Maintenance Plan, Traceability metrix, Issue log, Risk log and Validation Report by using necessary documents(7) CreateTest scripts to perform the UAT for the equipments like ePRO, IVRS/IWRS which are commonly being used in clinical trials(8) Responsible for arranging and participating teleconferences along with study team and vendors to discuss study related concerns(9) Being a "Single Point of Contact(SPOC)" for Third Party Coordinator, I was responsible for task allocation and time management for the delievery of allocated task.(10) Being a "Team Coordinator (TC)", I was responsible for handling a team in absence of Team Lead. And act as a primary point of contact for a team. Show less

(1) Handling Clinical trial samples of various studies and perform laboratory procedures used in the Diagnosis, treatment and prevention of disease. (2) Verify record and review Lab results on all performed tests. Ensure compliance with hospital Policies and laboratory procedures, including maintaining the cleanliness of lab Equipment, instruments and work area.(3) Executed and analyzed tests in areas including Clinical biochemistry, Urinalysis, Hematology.(4) Consistently commended… Show more (1) Handling Clinical trial samples of various studies and perform laboratory procedures used in the Diagnosis, treatment and prevention of disease. (2) Verify record and review Lab results on all performed tests. Ensure compliance with hospital Policies and laboratory procedures, including maintaining the cleanliness of lab Equipment, instruments and work area.(3) Executed and analyzed tests in areas including Clinical biochemistry, Urinalysis, Hematology.(4) Consistently commended for the timely, high-quality completion of both routine and clinical chemistry assays of patient specimens.(5) Ensured test-result validity before recording/reporting results, earning a reputation for meticulous attention to detail.(6) Evaluated quality control within laboratory using standard laboratory test and measurement controls. Show less