Data Management Clinical

PRIYANKA PATEL

*******.***@*****.*** 973-***-**** KY

Profile

•Professional with 12+yrs of experience in the Clinical Data Management and4 years of Data Acquisition Specialist arena to multiple companies in the Pharmaceutical industry and with multiple years executing my knowledge creating and maintaining large data sets for Big Data entities.

•Extensive hands-on experience of leading and contributing to the development of databases.

•Proven track record of Project management skills – Handling multiple studies on different TA’s.

•Hands on experience working on Submission Critical studies with crunch timelines.

•Proven track record of handling Data management vendors and performing Sponsor oversights and handling multiple studies without any quality issues.

•Expertise in driving studies from Start -Conduct – Closeout.

•Track record of working independently and with a team in development of all key data management documents.

•Demonstrated ability to effectively interpret and analyze data for the benefit of end-users.

•Detail-focused with experience across the full scope of clinical research operations; noted for poise and sound judgment in stressful situations, tenacity in overcoming obstacles, and ability to cultivate positive relationships with healthcare professionals and internal cross-functional teams.

•Skilled in team leadership, project management, mentoring, and liaising between clinical team, Biostats, CD Developers, etc.

•Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.

•Assist in creating external data transfer agreements, ensuring alignment with Standards and specifications to support data integration, analysis, and reporting.

•Provide support in setting up infrastructure for external data to flow into Clinical data pipelines.

•Assist in validation of all 3rd Party Data generated in clinical trials into Clinical Data pipelines.

•Develop and maintain working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.

•Assist in preparing function for submission readiness and may support Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits.

•Act as a representative for interactions with key external partners as part of the CT3 3rd Party Data Acquisition team.

•Support timely submission and ongoing maintenance of study-related 3rd Party Data Acquisition documentation in TMF.

•Follow procedural documents and assist in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements and include optimal processes.

•Assist in liaising with and reviewing work delivered by external partners (e.g., laboratories, eCOA providers, technology providers) performing services on behalf of ITCI.

•Escalate issues to CT3 leadership as appropriate.

•Responsible for representing the DM team, allocating resources, managing, and negotiating timelines.

•Design and development of case report forms, review, and update DMP (Data Management Plans), DRP (Data Review Plan), DTA (Data Transfer Agreements) CCGs (CRF Completion guidelines), AnnotatedCRF and Edit check specification document during study start-up.

•Strong experience in data quality review, data validation, data query, report generation, database lock and archiving final data.

•Extensive experience in the EDC system – RAVE, INFORM, Oracle Clinical and RED cap.

•Working experience with Phase I to Phase IV clinical trials using both paper and EDC trials.

•Experience in handling third-party data such as the lab data, e-PRO data.

•Hands on experience on working writing Edit Checks, Query Logics and User Acceptance Testing (UAT).

•Precision and accuracy in data collection, Validation, Data cleaning, SendQueries, AnsweredQueries,and management backed by well-developed communication skills, both written and verbal, adept at crafting professional reports, correspondence, presentations, and training materials.

•Experience with multiple types of therapeutic areas and study phases (U.S. IDE, post-market registry, Phase II, Phase III)

•Expertise in identification, review, reporting, Lab /PK/vendor reconciliation, and document management for Adverse Events and Serious Adverse Events (AE/SAE).

•Extensively worked on generation of study reports and tools such as J-Review.

•Worked on Study close out activities including Data Review, Protocol deviation, Data Freezing, Study Lock and PDF creation of Data (Data Archival).

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

•Fair knowledge on medical coding with MedDRA and Who Drug.

•Skilled in facilitating site activation, review, and monitoring of in-house data.

•History of ensuring all clinical documentation is audit ready and that operations / documents are compliant with MHRA, IND, IRB, FDA, Drug development and related regulations.

•Having hands-on experience in working on studies which are CDISC compliant, fair knowledge on SDTM.

•Experienced and proficient in cultivating strong, communicative relationships with clients as the main point of contact on all project related deliverables.

•Hands-on experience of working in Matrix Environment and challenging timelines.

•Experience working along with all stakeholders in clinical Research like: Biostats, Regulatory, Database programmers, Safety team, Clinical team, operational team etc.in developing strong partnerships to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting,budjeting.

•Proficient in handling IVRS like SyMmetric™ C6.

•Familiarity with ICH-GCP guidelines, 21 CFR part 11 and Electronic Submission standards.

•Formulate and develop data management SOPs and processes that align and address business priorities.

Technical Skills

•EDC Systems: Medidata Rave,Inform, Oracle Clinical RDC, SyMmetric 10.1.11.2,VIVA TMF

•Operating Systems: Windows 95/98/2000/XP/Vista/Windows 7, Window 2000/2003 Server/Workstation Administration, Windows NT 4.0 workstation.

•Reporting Software: J review, Crystal Report, Inform – v.4.5 and v.4.6.,Spotfire.Python,Tableau,Power BI,SQL.

•Therapeutic Areas: Asthma, Cardiovascular, and Infectious disease, Oncology and Musculoskeletal diseases, CNS,Cardiovascular, Neurology (Epilepsy), Respiratory.

•Certificate: SAS programming,Data Analyst.

KEY Skill:

Data Collection & Sensor Integration

Data Analysis & Visualization (Python, R, SQL)

Data Processing (ETL, Data Wrangling)

Programming Languages: Python, MATLAB, JavaScript, SQL

Database Management (MySQL, PostgreSQL, MongoDB)

APIs for Data Retrieval

Cloud Storage & Data Solutions (AWS, Azure)

Real-time Data Monitoring & Logging

Statistical Analysis & Reporting Tools

Data Visualization (Tableau, Power BI, Matplotlib, Seaborn)

Troubleshooting & Technical Support

Cosmik System LLC DE, USA

Senior Clinical Data Manager (Data Acquisition Specialist) Jan 2024 – June 2024

•Ensured all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.

•Organized and led regular data management team meetings, both internal and with the sponsor and the DMPM.

•Led the integration and calibration of sensors for real-time data collection in industrial systems.

•Developed scripts in Python to automate data extraction from APIs and sensors, reducing manual intervention by 30%.

•Managed the data flow from sensor networks to cloud storage (AWS) for processing and analysis.

•Conducted quality checks on collected data to ensure accuracy and integrity, identifying issues and improving data quality by 15%.

•Collaborated with cross-functional teams to define data acquisition requirements and create custom solutions.

•Created automated dashboards in Tableau to monitor real-time data and provide insights for decision-makers.

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•Attend meetings with external vendors, CROs, Investigative sites, Investigator meetings and scientific meetings as requested.

•Provide SaaS based production review of data management systems with clients as needed.

•Prepare various data reports that are submitted to the Sponsor, such as query listings, missing data and forms, site data summary and monitor summary reports – to show accuracy and consistency in the data across the study.

•Non eCRF data reconciliation (Lab data reconciliation, SAE).

•Perform Monthly Internal QC before data transfer using Tablue Dashboard.

•Attended and provided updates for data management services at cross- functional study team meetings both internally and with the sponsor.

•Develop electronic and paper Case Report Forms – (CRF/eCRFs) and provide detailed annotations of each data field.

•Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.

•Assist in creating external data transfer agreements, ensuring alignment with Standards and specifications to support data integration, analysis, and reporting using Python.

•Provide support in setting up infrastructure for external data to flow into Clinical data pipelines.

•Assist in validation of all 3rd Party Data generated in clinical trials into Clinical Data pipelines.

•Develop and maintain working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.

•Assist in preparing function for submission readiness and may support Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits.

•Act as a representative for interactions with key external partners as part of th CT3 3rd Party Data Acquisition team.

•Support timely submission and ongoing maintenance of study-related 3rd Party Data Acquisition documentation in TMF.

•Follow procedural documents and assist in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements and include optimal processes.

•Assist in liaising with and reviewing work delivered by external partners (e.g., laboratories, eCOA providers, technology providers) performing services.

•Escalate issues to CT3 leadership .

•Adhered to Client SOPs, the Data Management Plan, Working Procedures and study specific procedures in the implementation of tasks on the study.

•Organized and led regular data management team meetings, both internal and with the sponsor and the DMPM.

Intra Cellular Therapies NY

Lead Clinical Data Manager(Data Acquisition Specialist) Nov 2021 - Jan 2024

•Accountable for ensuring high data quality and abidance of timeliness of CDM deliverables for all assigned clinical studies

•Review, track and report status of all data management project(s) to senior leadership and align with key stakeholders

•Responsible for managing tracking the clinical trial information/status along with the planning and execution of the study and driving studies towards quality DBLs and other milestones.

•Provide support for the Data Management team and delegate tasks for the completion of data reviews to meet project objectives.

•Serve as the primary point of contact for site questions relating to study conduct issues; liaise with appropriate study team members as needed.

•Develop Data Management Plans, electronic CRF completion guidelines (eCCGs) that will deliver accurate, timely, consistent, and quality data.

•Provide input into development of Electronic Case Report Forms (eCRFs).

•Review and contribute to the development of Edit Check Specifications, Data Transfer Specifications, Study Specification document

•Extensive involved in DB testing (UAT using dummy data) and ensuring the DB go-live happens with high quality which does not further lead to any post production changes (PPCs)

•Facilitate study design, protocol development, and creation of eCRFs, data reviews and extensive data cleaning activities.

•Provide input into strategic operational development plans where requested.

•Ensure study teams and DM personnel are following SOPs and GCP guidelines.

•Prioritizes critical assigned study deliverables to ensure on-time completion.

•Develop training plans, change management plans and communication specifications for studies.

•Conduct/perform quality review of entered clinical data to ensure all the required discrepancies are identified and queries are raised in all instances including Third party data and escalate where needed

•With limited oversight, facilitate the development of study-specific clinical trial materials.

•Participate in departmental organizational process improvement.

•Assist with contract negotiation/review for vendors as needed; Management/support of selected vendors as needed.

•SAS Edit check,SAS data reporting SAS Data Manuplution.

•Attend meetings with external vendors, CROs, Investigative sites, Investigator meetings and scientific meetings as requested.

•Interacts effectively with other project and development staff to ensure streamlined forward movement of clinical projects.

•Ensures identified clinical study issues are resolved; implements and monitors corrective actions.

Parexel CA

Sr.Clinical DataManager Oct 2019 - Nov 2021

•Involved in performing Discrepancy management.

•Lead the development of specifications, implementation, and testing for the eCRF,the edit checks and data review and oversight listings (DVS).

•Lead development of specifications for custom reporting on the study.

•Perform project planning tasks and develop the project plan and timelines.

•Ensured effective communication of standard metrics and study status to internal/external teams.

•Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, and Regulatory Audits.

•Ensured all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.

•Ensured effective communications with site personnel were positive and collaborative.

•Interacted with staff across multiple sites and served in the role of mentoring, guiding, and providing project leadership to support DMs who are assigned.

•Ensured understanding of the study protocol, contract and scope of work for all tasks during set-up, maintenance and close-out of the study.

•Lead development of the data management plan and study specific procedures.

•Adhered to Client SOPs, the Data Management Plan, Working Procedures and study specific procedures in the implementation of tasks on the study.

•Organized and led regular data management team meetings, both internal and with the sponsor and the DMPM.

•Attended and provided updates for data management services at cross- functional study team meetings both internally and with the sponsor.

•Maintained and tracked meeting minutes, issues and decisions logs, and escalations.

•Provided support in negotiation of time lines and decision making on the study.

•Provide SaaS based production review of data management systems with clients as needed.

•Assess the training needs of study team members on an ongoing basis.

•Represented Data Management at internal/external audits and manage findings through resolution both operationally and within the Quality Management System.

IQVIA NC

Clinical Data Manager Feb-2016 - Aug 2019

•Work with various clients for all phases I – IV.

•Develop and implement Data Management Plans, eCRF Completion Guidelines, Data Review Guidelines and Data Transfer Specifications to provide to our clients and site teams.

•Develop electronic and paper Case Report Forms – (CRF/eCRFs) and provide detailed annotations of each data field.

•SAS Edit check,SAS data reporting SAS Data Manuplution.

•Using Spotfire review data reporting,Edit check .

•Weekly participate in study/project team meetings with Sponsors and Project Managers providing updates on study status and timelines.

•Developed and written corporate communications to internal and external clients.

•Developed training plans, change management plans and communication specifications for studies.

•Create data edit checks for accurate data validation and query management for all studies.

•Prepare test databases for UAT system testing and provide guidelines for testing to users,

•Prepare various data reports that are submitted to the Sponsor, such as query listings, missing data and forms, site data summary and monitor summary reports – to show accuracy and consistency in the data across the study.

Genentech CA

Clinical Data Associate Oct-2012 - Jan 2016

•Conduct manual data review and write data clarifications along with Discrepancy.

•Management in writing and reviewing CRF completion guidelines.

•Resolve data clarifications, according to protocol, DMP and Edit check document.

•Conduct basic quality control procedures.

•Perform SAS listing validation. Escalate problems to the attention of the Data Team Lead or Project Overseeing Manager.

•Edit check testing and validation for test cases.

•Training new resources about the database and study protocol.

•Non eCRF data reconciliation (Lab data reconciliation, SAE).

•Perform Monthly Internal QC before data transfer.

•Develop and maintain good communications and working relationships with the CDM team.

Education

Gujarat University Ahmedabad, India

Bachelor in Organic Chemistry 2009

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