Hena Singh Email and Phone Number

As a Data Management Lead my responsibilities include but are not limited to:• Provide clinical data management leadership within the study team to align on and drive data collec-tion requirements for more than one complex clinical development projects.• Efficiently plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects.• Responsible for end to end clinical data management activities and serve as a primary point of con-tact for external study team members.• Provide strong quality and project oversight over third party vendor responsible for data manage-ment deliverables.• Take a leadership role to gather content and integration requirements for EDC and close collabora-tion with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforce data standard conventions and quality expectations for clinical data per defined processes at BMS.• Author, review/revise DM related study plans including Data Management Plan, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.• Chair Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data quality and completeness.• Represent DM on cross-functional project teams & submission Teams

In the role as Clinical Data Quality Associate, my responsibilities included:• Actively participate in protocol review and give input in eCRF design from operations standpoint.• Independently and efficiently oversee and perform, with quality, all data cleaning activities in accord-ance with the DVP documentation within an assigned study.• Perform user acceptance testing of clinical data systems.• Develop Data Review Plan in collaboration with the Clinical Data Manager include specifications of data listings and reports required to facilitate/perform the data review process.• Develop eCRF Completion Guidelines• Collaborate with CRAs and investigator sites to resolve data issues and ensure timely data entry and query resolution.• Report status of data review and data issues to the CTM. Escalate issues appropriately.• Chair the Data Review Meetings and drive data cleaning activities to ensure timely database lock.• Drive data-related problem solving with CTM, CDM, statisticians, medical directors, and other clinical trial team members to ensure all data review issues are resolved. This includes identification of the problem, identifying the solution and coordinating the execution of the solutions.• Participate in development of data transfer specifications in collaboration with Biostatistics.• Mentor junior level staff on all associated tasks within a study

As a Senior Reviewer, major areas of responsibilities are:• Ensure the integrity of the data generated for Bioavailability Study, Stability Testing or Validating new methods • Review of audits system audit trails in the empower software • Training and Mentoring staff members• Periodic check for accuracy of laboratory instrument calibration status, log book and column en-tries• Participate in lab deviations, investigation and audits when needed• Work independently, organized, effectively prioritize projects and work in team environment on multiple projects in a concurrent manner

In the role of a Reviewer some of my responsibilities were:• Reviewed the testing performed by QC chemists and associated documentation for accuracy and cGMP compliance in laboratory notebooks • Interacted with Quality Assurance on routine basis on the data submitted and corrections if any

In the Clinical Data Manager role, I:• Drove cross-group collaboration between clinical trials and statistics• Crosschecked for discrepancies against the study protocol and edit check per DMP, resolved er-ror• Finalized data for data lock.

In the role of a Clinical Data Manager my responsibilities were:• Wrote Data Management Plan for ongoing studies. • Co-ordinated across teams of clinical trial group members and statisticians to develop and im-plement CRFs• Defined edit checks and worked to resolve queries for data lock.

In the role of a Clinical Data Manager my responsibilities were to:• Write Data Management Plan for ongoing studies. • Conducted cross team meetings to define AE, SAE, logic checks and flags for the Database• Co-ordinated across teams of clinical trial group members and statisticians to develop and im-plement CRFs• Oversaw the programming of the CRFs by the Database Analysts and programmers• Defined edit checks and worked to resolve queries for data lock.• Participate in development of department SOP’s to be compliant with ISO 9000, GMP and with the FDA Guidance for Industry for Computerized Systems Used in Clinical Trials.

In the role of Clinical Database Analyst, I:• Developed and implemented CRFs according to protocol requirements. • Programed CRFs to populate the database and loop through predefined logic checks.• Generated queries from data cleaning and coordinated with CRAs to resolve and lock for analy-sis.

As a Senior CRA my responsibilities were but not limited to:• Authoring protocols in conjunction with the clinical team and platform of engineers, MD and statis-ticians • Preparation and submission of documents for IRB approval, developed Informed Consent docu-ments with input from Legal Department • Managed the study budget from beginning to close-out• Oversaw clinical trial vendors• Performed site evaluations and approved sites for selection. • Conducted Investigator Meetings, oversaw the monitoring of trials.

I was involved in research on dermal bio-availability of phenols and heavy metals.• Developed methods for studying dermal extraction of soil-aged chemical residues.• Work included handling of radioisotope chemicals aged in soil, collection of data and computer assisted data analysis.• Evaluated the Uncertainty Factor method currently used by regulatory agencies to extrapolate data collected from chemical studies on animals to humans.• Prepared presentation material for presentations at academic workshops and conferences.Student Research Project: My student research project involved development of a method for identifi-cation of an Acrylamide metabolite in urine using GC-ECD and GC-MS. It also entailed data collection and analysis, final report preparation and, oral and poster presentation of the project.Student Internships: My two industrial internships include 1. Clinical internship at Corning Clinical Laboratories, Teterboro, NJ. My work included performing drug confirmation using GC-MS and data entry.2. My forensic internship was at State Medical Examiner’s Office, Newark, NJ. This work involved drug screening and conformation in human specimens by GC, MS, RIA, TDX, HPLC.