Shahana Sayed Email & Phone Number

Boston, Massachusetts, Us

Boston, Massachusetts, Us

Boston, Massachusetts, Us

Cambridge, Ma, Us

Morrisville, Nc, Us

Morrisville, Nc, Us

Morrisville, Nc, Us

• Assists in preparing clean databases, including processing of discrepancies and queries• Involved in the preparation of the DMP• Reviews CRFs, data listings, and database to ensure that all captured data follow the rules outlined by the protocol and data management plan• Generates paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process• Reviews responses to queries for appropriateness, resolves any discrepancies and modifies the database accordingly• Assists in developing a standard set of test data for use in testing data entry screens, data listing presentation, and programmed logical edit checks, as required• Prepares documentation noting the testing changes and performs follow-up testing to validate that the changes have been made, as required• All other projects as assigned

Morrisville, Nc, Us

• Develop clinical trial databases for paper and RDC studies using Oracle Clinical on the receipt of approved final protocol under stringent timelines• Program validation and derivation procedures • Entering test data for the validations created to confirm the programming logic of the procedures and work in collaboration with the data management team in getting checks activated • Quality control testing of new studies as well as the amendments/ changes made to the study database created for the client; internally as well as for the external vendors.• Develop Case Report Forms for clinical trials using Teleform and perform quality control testing as assigned• Train on, and follow, sponsor's Standard Operating Procedures as applicable• Mentor the new members of the team

Us

• Review and annotate Case Report Forms (CRF)• Creation of Questions, Question Groups, form layout templates and DVG’s in Glib as per the working practice and process for paper and RDC studies• Plan and co-ordinate database design, development, implementation, maintenance, and user support of clinical systems.• Provide database design, Programming Edit Checks, Validating the Programs, Resolving the database issues, Views, Custom Templates• Program, test, and document databases in accordance with programming standards and validation procedures.• Understand and comply with Core Operating Procedures and Working Instructions.• Meet milestones as assigned, and interact with the project team to meet timelines, responsibilities and deliverables.• Develop and maintain good communications and working relationships with teams and external clients.• Perform other programming tasks as necessary to support Clinical Data Management.• Responsible for clearly documenting all work; managing assignments to meet timelines and delivering high quality; function as a team member.

New York, New York, Us

• Manage the activities of supporting and implementation of new clinical trials. Implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables for the site based project teams according to specifications.• Plan and co-ordinate database design, development, implementation, maintenance, and user support of clinical systems for paper and RDC studies for Phase I group• Review of the database designed by other associates as per the data standards catalogue• Handling maintenance issues• Perform all activities as assigned by the manager

New York, New York, Us

- Perform Discrepancy management, Database UAT testing, Edit Validation checks, Manual Data Listings review in Oracle Clinical- Liase with study team members and vendors (Cognizant Technology Solutions and Siro ClinPharm) to meet study deliverables- Perform study close-out activities prior to study lock

Master Of Science, Analytical Chemistry

Bachelor Of Science (B.Sc.), Microbiology

Education record