Divya Manchala

More than 5+ years’ experience working in Clinical Data Management and responsible for end to end delivery of DM deliverables with quality and efficiency.

Experience in clinical trials phases I- III, including early and late phase clinical development.

Worked in different databases including Medidata Rave, Inform.

Worked on multiple projects simultaneously in various phases and therapeutic areas of clinical trials Oncology, Hematology, Diabetes, Cardiology and Respiratory.

Experience working on in study start up, study conduct, Final Database and Interim lock.

Coding knowledge in MedDRA and WHO Drug systems.

Sound knowledge in US FDA and ICH GCP guidelines.

Experience working on revenue recognition and budget reconciliation from the DM perspective.

Strong working knowledge of project set up, quality assurance, data review, data analysis, database clean up and database closing using data management systems.

Developed DTA (data transfer agreement) with various external vendors including Labs, ePROs and PK vendors.

Participated in CRF Design, Discrepancy management, Lab Reconciliation, SAE Reconciliation, Biomarker Reconciliation,.,

Review Protocol amendments from DM perspective and provide comments as needed.

Developed Data Validation Specification document with Dynamics required for the study.

Lead CRF design review Meeting with the clinical and sponsor team and documented their feedback.

Worked on various DM documents including , Data Management Plan, Edit Check specifications, SAE reconciliation plan and Data Entry Guidelines..

Functioned extensively in data locking and freezing activities.

Good communication and team working skills, with commitment to achieve CDM objectives in a timely manner.

Communicated and escalated project level issues including processes, timelines, resourcing, performance to study manager and portfolio manager as needed.

Worked collaboratively with Clinical Programmers, Statistical Programmers, Biostatisticians, Clinical Research, Regulatory and Project Management staff to meet project deliverables and timelines for all assigned studies.

Lead the team with Data Review for major deliverables on assigned studies for Primary Analysis, DSUR, , CSR and Interim Analysis,.

Lead the Data Review Meetings internally and proactively brought any foreseen issues to the discussion and proposed solutions from DM point of view.

Reviewed Protocol amendment changes with the Change control team and discussed timelines, scope of changes and risks and followed the changes through DB go live.

Generated metrics and experience generating customized DM reports from J Review.

Coordinating with the team for monthly tasks review of Vendor and Non-Vendor offline listings, sharing vendor trackers with Vendors and documenting.

Through knowledge of Trial Master File (TMF) set up, timely filing of documents and being inspection ready.