Manasa Soma

Email: manasa.2603@gmail.com
Phone: 925-549-5254

Professional Summary:

 Experience in Clinical Data management, CRO and vendor management

 End to end experience in all the activities of Data Management (Set-up to Close out),
 Proven communication, presentation and interpersonal skills.
 Efficiently handle multiple projects with rapidly changing priorities and timelines.
 Reviewing data discrepancies generated either manually or programmatically.
 Extensive knowledge of CRF design, Edit checks creation, data cleaning and query process, Lab
Data Reconciliation, SAE Reconciliation.
 End to end experience in various activities of Study start up, conduct and lock phase.
 Expertise in Database QC, Database Audit.
 Proficient in multiple Clinical Data Management Systems such as Medidata Rave, Veeva Vault,
Inform and Bioclinica Express 5.3.
 Experienced in communicating and managing CROs and Sponsors on multiple projects.

 Responsible for leading and overseeing data management tasks from study start-up through database
lock and worked closely with multiple cross functional groups including Clinical Trial Managers
(CTM’s), Biostatistics and Data Management vendors to ensure database development, data
review/cleaning, database lock, and receipt of final database deliverables are in compliance with
standard operating procedures and regulatory agency guidelines.

 Experienced in working with multiple teams in multiple projects at same time.

 Highly motivated, diligent, innovative and detail oriented.
 Knowledge of regulatory guidelines and standards like ICH/FDA guidelines, CDISC/SDTM &
CDASH standards, GCDMP, MedDRA, WHO Drug Dictionaries etc.

THERAPEUTIC EXPERIENCE:
 Oncology
 Ulcerative Colitis
 Respiratory Disease
 Gastrointestinal Disease
 Cardiology

PROFESSIONAL EXPERIENCE

Company: LOXO Oncology at Lilly,

South San Francisco, CA.
Duration: Mar 2023 –Present
Designation – Data Management Consultant

Responsibilities –
 Worked on various Phase I a/b and Phase II Oncology trials.
 Performs routine and critical data review as specified in the study Data Management documents.

 Involved in review and updating of Data Management documents such as: CRF completion
guidelines, data management plan (DMP), data reconciliation plans, edit check specifications (ECS)
as per the study protocol updates or any process changes.
 Created and updated Data transfer specification documents for different vendors of the study as
needed.

 Worked to ensure all Data management activities stay within full compliance of Standard SOP’s and
regulatory agency guidelines.

 Oversee the activities performed by CRO and represented data management from sponsor in weekly
DM meetings.
 Managed external data transfers with different vendors of the study.
 Reviewed the reconciliation document and discrepancy trackers for any reconciliation performed by
CRO and provided guidance in resolving any issues.

 Ensured the DMP and CRF completion guidelines for each study are kept current with protocol
updates.

 Performs quarterly data listings review for all the studies as per the DRP and issue queries/re-
queries for the data inconsistencies until resolution.
 Follow up with CRA’s for any data entry issues or any unresolved queries.
 Created J-Review output reports to assist study teams in their weekly/monthly data reviews upon
request.
 Involved in preparation of all documents needed for approval of any postproduction changes.
 Updated CRF and edit check specification documents as needed for any database related updates.

 Performed Sponsor user acceptance testing (UAT) of electronic data capture (EDC) database, edit
checks, reports and listings, and interactive X response systems (IxRS) as needed.

 Involved in data integrations to gather the details and integration requirements for EDC and
collaborate with external vendors supporting data collection systems.

 Coordinated data deliverables with the CRO for studies which are fully outsourced for Data
Management.
 Involved in planning the strategy for data cleaning during database lock and follow up with other
functional groups and vendors for any unresolved issues and review the clean patient tracker and
other metrics reports to track the clean status of the study in preparation for database lock and
participated in combined group study calls between CRO and sponsor.

Company: AstraZeneca (Acerta),

South SanFrancisco, CA.
Duration: Jun 2016 –Dec 2018
Designation - Clinical Data Manager

Responsibilities –
 Worked on various Phase II/III Oncology trials.
 Participated in various Database build activities by involving in development of protocol specific
eCRF’s, writing specifications, developing edit checks and thorough UAT to ensure data will be
captured as per the Clinical Protocol.
 Designed and reviewed CRF pages and eCRF entry screens and associated CRF/eCRF visit
structure, indexed and version control, co-coordinated with team members responsible for the
associated database design.
 Selected and reviewed eCRF’s to ensure they were designed as per Protocol requirements.
 Maintained and updated the study files as per the requirement of the protocol.
 Developed and reviewed the Data Review Plan (DRP), Data Management Plan (DMP), CRF
 Completion Guidelines (CCG) and other DM specific documents.
 Held meetings with the other teams to discuss and resolve the data management issues.
 Performed all the data management activities from study start-up to database lock.
 Discrepancy management involves query generation for data inconsistencies by reviewing the data
listings generated periodically.
 Tracking the study status through DM metrics report generated to ensure the quality expectations
are met.
 Reviewed the data listings generated periodically and querying on data discrepancies and closing
the resolved queries in Express 5.3.
 Participating in the weekly and Bi-monthly held study team meetings.
 Involved in Interim Database snapshot activities by reviewing all the data to be clean by Quality
checking all the activities including to ensure all the forms were completed. And confirmed on all the
data has been cleaned fully including Data Listings Review, External Data reconciliations and coding
issues resolved . Verified and confirmed if all outstanding queries were answered and resolved on
time.
 Participated in eTMF/inspection readiness training and worked on eTMF documentation preparation
for all the studies to make sure eTMFs are up to date.
 Worked on developing DM documents including DMPs, CRFs, CRF completion guidelines, Edit
checks, UAT specifications and drafting DRP.
 Involved in database preparation for the new study by assisting lead data manager in protocol review,
summarizing the EDC Changes and preparation of mock eCRF’s
 Worked on documentation in eTMF for multiple studies
 Developed and reviewed specifications for any database changes and performed UAT.
 Assisted in Database lock activities by tracking the study status and sending the reports to the teams,
also in preparation of Database lock checklist.
 Worked on Post production changes and documentation. Developed IA tracker to track the database
changes after each IA and documented the supporting documents for eTMF.
 Reviewed data discrepancies and resolved those using DMPs.
 Raised queries to resolve data discrepancies.
 Day-to-day discrepancy management to ensure data quality and consistency.
 Performed SAE reconciliation.
 Assisted study manager for various activities during database lock activities.
 Notified investigation site personnel for any outstanding queries that were not attended by holding the
meeting with clinical operations teams.
 Reviewed all un-coded medical terms and resubmitted to dictionaries.
 Performed data validation which included manual discrepancy management, listing review, SAE and
external lab data reconciliation.
 Prepared data listings for other teams when required.

Company: PAREXEL, India

Duration: Jan 2014 - Oct 2015
Designation: Clinical Data Associate

Responsibilities –
 Performed data management activities on Electronic data capture (EDC) studies.
 Efficiently performed study start-up activities.
 Prepared and reviewed eCRF completion guidelines and assisted in revision of a DVS including
addition of new edit checks.
 Prepared trial level validation documentation such as checks, UAT plans, reports and conventions
necessary to ensure high quality and consistent data.
 Reviewed clinical trial documentation. Contributed to the preparation of documents such as
protocol, CRFs and data completion guidelines.
 Developed and documented standards, SOP’s, and work practices
 Reviewed clinical trial data to identify missing, incomplete and inconsistent data
 Interacted with other departments to improve the accuracy and quality of data
 Worked on studies in the therapeutic areas of Oncology, cardiovascular, metabolic disorders,
respiratory system.
 Integrated, reviewed and reconciled data received from external vendors with clinical database and
ensure readiness for analysis.
 Performed Clinical lab and PK reconciliations and raised queries wherever data mismatch issues
found and followed up to get the resolutions.
 Handled the tasks of maintaining data management project file documentation, finding and reporting
the status of data management activities.

Education
 Bachelor of Pharmacy, Kakatiya University, India
 Masters in Clinical Pharmacology, Kakatiya University, India
 Trained and Certified in Clinical Trials Design and Clinical research Data Management Program,
India
 Registered Pharmacist, India

Relevant Skills
 CDMS – Medidata Rave, Bioclinica Express 5.3 and Express 5.4, Veeva CDMS Vault, InForm,
 Clinical Trial Management systems: ClinTrak (TMF), Veeva Vault
 Data Review Tools: J-Review
 Operating systems – Windows XP, Windows Vista, Windows 7
Microsoft Office: Word, Excel, Publisher, PowerPoint, SQL Server, SAS
Programming