Data Management Clinical

PROFESSIONAL SUMMARY

• * years of working experience in the field of Clinical Data Management delivering Data Review and Data Management activities in various therapeutic areas and phases in a timely manner.

• Extensive experience in working with Phase I to Phase III clinical trials.

• Experience in working on various EDC databases including Medidata Rave, Open clinica, Phase forward Inform and Medrio.

• Developed and maintained Data Management Plans (DMP), Data Transfer Agreements (DTA), CRF Completion guidelines (CCGs), and made sure they followed throughout the project life cycle.

• Communicated and coordinated with different global teams in various studies.

• Extensive knowledge in different phases of clinical data management including study start up, study conduct and study lock.

• Worked extensively during study start up on CRF designing providing study specific and protocol specific guidelines.

• Provided and assisted in creating Edit Checks, Query Logics and User Acceptance Testing (UAT).

• Extensive experience in study conduct activities such as validating the data, cleaning the data, Discrepancy management and SAE Reconciliation.

• Extensive experience in performing listing and manual review.

• Worked extensively on study closing activities including Data Review, Data freezing and Study Lock

• Worked on compliance checking of data review guidelines in accordance with the regulatory guidelines.

• Knowledge in Medical Coding with MedDRA and WHO Drug dictionaries.

• Thorough knowledge in Database QC, CRF tracking and Database Auditing.

• Working experience with statistical programming team and applicable knowledge on SAS.

• Good knowledge on ICH-GCP and 21 CFR Part 11 guidelines

• Good verbal, written, interpersonal and communication skills.

• Worked on multiple projects simultaneously with little to no guidance.

SKILLS AND COMPETENCIES:

Clinical Data Management systems

Medidata Rave, InForm, Open Clinica and Medrio

Packages

MS Office

Therapeutic Areas

Orthopedics, Respiratory, Cardiovascular, Vaccines, Pulmonology

EDUCATION:

• National Institute of Pharmaceutical Education and Research (NIPER), India

Major: M Pharmacy

• Sri Padmavathi School of Pharmacy, India

Major: B Pharmacy

WORK EXPERIENCE

Designation – Clinical Data Manager October 2022- October 2023

Therapeutic area – Orthopedics (Medical Device)

Osteal Therapeutics

• Performed end to end Data management activities. Reviewed Clinical research Protocols, Pharmacy manual, Study Treatment Guide. Coordinated Clinical Trial Setup project activities.

• Developed and Maintained project documents like Source worksheets, Data Management Plan, Data Review Plan, Data validation documents, CRF completion guidelines, Database change request forms and Study Treatment Cards.

• Developed Data management SOPs, best practices and templates related to clinical data management.

• Attended and participated in Product training, Investigator meetings, Clinical Research Coordinator meetings and DSMB meetings that take place quarterly.

• Reviewed and worked on an action plan to resolve the issues identified by Data Safety Monitoring Board Committee which are critical for the study success.

• Was responsible for updating safety data weekly required for Safety Analysis and end point analysis.

• Communicated study success percentage every week to the entire clinical team and Board of Directors by reviewing the endpoints for Experimental vs Control subjects.

• Extensively worked with database developers on the design, data model, testing and implementation of study databases.

• Responsible for conducting monthly data review meetings which include the query metrics, and extensive review of AEs, SAEs, PDs and Device Deficiency data.

• Responsible for User Access Management for sites and Internal team.

• Ensured data integrity by establishing appropriate data management processes (e.g., protocol compliance reporting, missing or discrepant data queries, data quality check)

• Interacted with the sites and CRA to coordinate error resolution.

• Worked with Regulatory and Quality departments to reconcile and report clinical trial data.

• Was responsible for generating/reviewing data listings, query reports, edit checks and performing User Acceptance testing.

• Involved in the training of internal team, CRA’s, CRO and vendors based on the project requirements.

• Performed accurate and consistent coding of medical terms and drugs using MedDRA and WHO-DD coding dictionaries.

• Provided inputs to the Manager on timelines, resources, and scheduling as required.

• Responsible for updating visit tracker and sales force weekly to ensure sites are following the protocol specified window for the visits and to track missed visits.

• Keep senior staff informed of study progress and escalate issues as required.

• Manage external and internal communications about data management timelines.

Designation – Lead Clinical Data Manager October 2021- August 2022

Therapeutic area – Vaccines, Pulmonology

Firma Clinical Research

Responsibilities:

• Lead the Data management activities to support clinical studies.

• Experienced in allotting units for budget planning.

• Experienced in Decentralized clinical trials and e-source.

• Create Data Management Plan, Edit check document and CRF specification guidelines.

• Perform user acceptance testing (UAT) for EDC systems.

• Clean database by generating, reviewing and closing query resolutions through daily Case Report Form (CRF) review.

• Help site support to answer study-related questions and perform EDC training as needed.

• Communicate with CRA, sponsor and third-party vendors (such as central laboratory) to discuss study related functions.

• Perform AE/SAE (Adverse Event/ Serious Adverse Event) and third-party data reconciliation.

• Communicate with other internal departments to maintain and track project timelines.

• Perform quality control on various types of tasks, such as review edit check listings, manage data management documentation and study reports.

Designation -Lead Clinical Data Manager Mar 2017 to Sep 2021

Therapeutic area -Pulmonology, Oncology

Alkem Laboratories

Responsibilities:

• Handled Complete life cycle of Data Management (From study setup to close out).

• Participated in study set-up, validation and implementation of clinical databases.

• Trained clinical team and other DM team members on the project specifics and served as primary contact for data on the project.

• Developing of study documents like Data Validation Plan, CRF Filling Guidelines and Data Entry Guidelines etc.

• Assisted in developing case report forms and CRF completion guidelines.

• Performed UAT for Screens and Folder dynamics.

• Developed test scripts and performed UAT of edit checks and validation of manual listings.

• Ensure adherence to the basic protocol requirements, SOP's, ICH GCP and Standard Guidelines

• Review data through listings and auto queries.

• Vendor Management: Creating Data transfer agreements, working with the vendors on regular imports and reconciling the data.

• Performed PK, Biomarker, Imaging, IVRS Reconciliation and SAE Reconciliation.

• Executed external vendor data reconciliation for several clinical trials.

• Worked on Lab reconciliations including Local labs and central labs

• Coordinated with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.

• Proactively identified potential study issues and recommended implementation solutions.

• Represented data management and coordinated with internal/external teams.

• Responsible for supporting database-locking activities, including planning and executing listing reviews and identifying remaining clinical and monitoring tasks.

• Contributed towards reviewing guidelines/checklist that aids in streamlining of activities for Data Management (DM) during study closeout.

• Oversee data-management lifecycle of large clinical trials, composing and verifying reports and results.

• Freeze and lock data as appropriate in time for statistical review, interim quality review, interim and final database lock.

Designation - Clinical Data Associate Aug 2015 to Feb 2017

Therapeutic area -Cardiovascular system

Laurus Labs

Responsibilities

• Review clinical trial protocol, data management plan, data validation plan, and other data management documents.

• Assisted in the preparation of e CRF specifications.

• Performed data review, validation, query development and resolution to address potential discrepancies with clinical trial data.

• Performed SAE data and lab data/ vendor data reconciliation.

• Reviewed Medical coding using MedDRA, and WHO Drug dictionaries.

• Performed manual and listing review to ensure clean data.

• Worked closely with internal and external teams.

• Track progress of clinical studies, ensuring projects meet timelines and requirements.

• Developed test plans and performed testing to validate databases built.

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