Sunitha Golla

Clinical Data Manager

Ph. 908-***-**** Email: ad1oov@r.postjobfree.com

Career Summary:

§ Over 7 years of Clinical data management experience working in large Phase I-III clinical trials utilizing Medidata Rave and Oracle Inform EDCs.

§ Adept in the different phases of the clinical data management process from study start-up to study close out.

§ Proficient in Case Report Form (CRF) design, Edit Checks creation, data cleaning and query process, Lab Data Reconciliation, SAE Reconciliation, Discrepancy Management, Data Freezing, quality control, User Acceptance Testing (UAT) and database lock processes.

§ Extensive experience developing and maintaining Data Management Plans (DMP) for the project life cycle.

§ Experience in data analysis and data governance and in developing Data Transfer Agreements.

(DTA) with external vendors and coordinating with global teams for several studies.

§ Experience in providing study specific and protocol specific guidelines during study start up on CRF designing.

§ Experience in compliance checking of data review guidelines in accordance with the regulatory guidelines.

§ Experience in audit process of the data management with the sponsors.

§ Proficient knowledge in Database QC, CRF tracking and Database Auditing.

§ Experience in vendor management, team management and client interaction.

§ Sound knowledge in Medical Coding with MedDRA and WHO Drug.

§ Sound knowledge on ICH-GCP, CDISC and 21 CFR Part 11 guidelines.

§ Possess excellent interpersonal and communication skills. Therapeutic Areas:

§ Oncology

§ Cardiovascular

§ Immunology

§ CNS

§ Diabetes

§ Respiratory

Professional Experience:

IQVIA, Durham, NC Mar 2020 – present

Data Team Lead/Associate Data Team Lead

Served as primary data team lead for multiple clinical studies.

Lead and coordinated with the internal data management and cross functional teams for study startup, conduct and database lock.

Managed project timelines, resources, study budget and finances.

Performed Protocol and CRF reviews, and annotation for CRF, ALS.

Served as primary point of contact for study specific customer relationships.

Worked on DMPs, CRF completion guidelines, Edit Check specs, data review and data transfers.

Performed several migration activities end to end.

Vendor management and query management.

Assisted in designing CRFs and creating Edit Check specifications.

Collaborated with different stakeholders of the study to develop CRFs and database for collecting clinical trial data.

Performed and coordinated all aspects of Clinical monitoring process. Syneos Health Jan 2018 – Feb 2020

Clinical Data Manager

Overseeing data management activities for assigned clinical trials.

Gathering requirements from the clinical team for the development of EDC system.

Assisted in designing CRF and creating edit check specifications.

Collaborating with different stakeholders of the study to develop CRFs and database for collecting clinical trial data.

Manage the data life cycle of the studies assigned from start-up to close out.

Performed activities like Protocol Review, Reviewing of CRF, Annotation for CRF.

Developing database specifications including CRF specifications and Edit Check specifications

(DVS) for assigned clinical trials.

Authoring test scripts and performing UAT of the database to make it available for the clinical trials.

Designing, generating and reviewing of study metric reports as required by the study team.

Periodic manual reviewing of clinical trial data for discrepancies and query management.

Performing external data reconciliation such as SAE and lab data reconciliation.

Updating and maintaining the lab ranges for local labs and batch upload for central labs.

Performing query management and discrepancy management of trial data.

Tracking and managing the status of allotted clinical trials in data management aspect.

Oversaw manual and automatic discrepancy management activities.

Developed DMP, CRF completion guidelines (CCGs) and other study related documents. Syneos Health Oct 2015 – Dec 2017

Clinical Data Analyst

Reviewed clinical research study protocols.

Worked with database developers in designing the database, data model, testing and implementation of the study databases.

Developed CRF and CRF completion guidelines.

Worked with clinical trial coordinators in designing the CRFs and Clinical database.

Reviewed and tested the EDC functionality and validation procedures.

Performed UAT, Edit Checks, role testing and folder dynamics.

Worked on SAE and Lab reconciliation.

Involved in clinical data management activities for clinical trial Phases I, II and III.

Developed and reviewed data management plans and data validation plans.

Performed soft lock and hard lock of the database at the completion of the study after thorough QC of data.

Coordinated between the internal and external teams of the study. Education:

Bachelors in science, Major in Biology, Zoology & Chemistry

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