614-***-**** adv3rf@r.postjobfree.com

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ISATU TURAY

PROFESSIONAL SUMMARY

Accomplished Senior clinical data manager successful orchestrating operations and leading clinical data process. Robust background encompassing problem resolution, study development and client facing. Thrives in a fast-paced environment with unsurpassed drive, passion, and commitment to exceeding expectations in client satisfaction, revenue, and cost controls.

THERAPEUTIC AREA

• Rare Disease: Fibrodysplasia ossificans Progressive (FOP)

• Oncology: Breast, ovarian, Prostate

• Medical Device: Pacemaker, Cardiac Stent

• Infectious Disease – TB, Hepatitis B, COVID 19, Influenza

SKILLS

• Data Entry

• Research Protocols

• SOP Compliance

• SOP Development

• Data Quality

• Medidata Rave

• Good Clinical Practices (GCP)

• User Acceptance Testing (UAT)

• Clinical Database Development

• Experienced in using the following database: Oracle Clinical, CTMS (IMPACT), IBM, Inform, Medidata Rave

• Basic Knowledge in SQL and SAS

• Proficient in using MS OFFICE (Excel, Word & PowerPoint) Lynx, WebEx, SharePoint

• E-TMF: Trial Interactive, Veeva Vault

WORK HISTORY

SENIOR CLINICAL DATA MANAGER I 01/2021 to Current

IQVIA, REMOTE

• Manage all data management (DM) tasks from study start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.

• Represent DM as the functional lead at internal and sponsor project team meetings.

• Communicate study status, data trends and issue resolution with internal team and Sponsor.

• Manage DM related aspects of the project.

• Provide training of DM staff on project specific processes.

• Develop, generate, and analyze project progress and metric reports, and remediation activities, to DM management, study team and Sponsor.

• Work with DM program administrative manager to provide resource and budget projections.

• Presents EDC and CRF completion at Investigator Meetings.

• Oversee daily team member activities.

• Serve as a Data Management team lead.

• Ensure project activities are performed within budget and according to expected timelines.

• Performs DM tasks, based on the approved Data Management and Data Review Plans such as: Discrepancy management, Data Reconciliation (Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and 3rd party vendors.

• Oversees Clinical Data Management System Development and Maintenance.

• Coordinates with vendors and cross-functional teams to assure timely completion of tasks to meet established timelines

• Implement DM strategy on the project based on scope of services and as laid out by DM management.

• Coordinate with Technical Design and Clinical Programming team as well as Project Management to develop and maintain DM timelines for startup and mid-study updates including the development, testing and implementation of all data capture tools.

• Coordinate with the Technical Design and Clinical Programming team and 3rd party vendor to develop and test the CRF and edit check specifications as well as custom EDC reports to support protocol requirements.

• Participate in BDM preparation meetings including discussing overall DM strategy collaborating with Manager as required.

• Represents Data Management at Bid Defense Meetings.

• Coordinate with the EDC programmers and 3rd party vendors in the setup and testing of electronic data capture (EDC) technologies such as IRT, ePRO and eCOA as required per the scope of work.

• Facilitate project team and Sponsor review of system documents including Time and Events Schedule, CRFs, Edit Checks, revision specifications.

• Perform testing for EDC systems as required per scope of services and standard operating procedures.

• Oversee System and Data Listing Testing Activities.

• Prepare project-specific slide presentation from DM template functional slides in collaboration with DM management.

• Perform testing for EDC systems as required per scope of services and standard operating procedure.

• Provide feedback to the other project team members and managers to improve the deliverables.

CLINICAL DATA MANAGER II 07/2019 to 01/2021

IQVIA

• Managed queries on assigned clinical studies.

• Completed database cleaning and database lock and assisted Trial biostatisticians with analysis file creation and statistical analyses.

• Participated in Designing CRF's, CRF completion guidelines and database user requirements.

• Ensured DM documents are filed per company Standard Operating Procedures (SOP) in study TMF.

• Ensured data system compliance by following establish guidelines of regulatory authorities.

• Performed data cleaning/reconciliation activities as specified in company procedural documents and study-specific Data Management (DM) documents.

• Worked with vendors such as central laboratories in support of timelines and data-related deliverables.

• Managed study through these phases in a timely and professional manner while adhering to the established clinical trial and regulatory standards and the financial constrictions.

• Generated and deliver reports to study team members.

• Coordinated the archiving of study databases and related documents.

CLINICAL DATA MANAGER I 03/2016 to 07/2019

IQVIA

• Was Responsible for the execution and adaptation of clinical data management plans and processes for collection, management, reporting and analysis of data on behalf of project teams and sponsors.

• Used Microsoft Word and other software tools to create documents and other communications.

• Collaborated with multi-functional project teams and functional specialists to identify, modify, maintain, test, and review project databases, data, and CRF/eCRF documents, reports, and timelines

• Performed database lock and freeze activities.

• Regularly reviewed quality of data output to ensure all data created meets integrity, quality, validity, and reliability standards and is collected, compiled, tested, and reported on in accordance which project and sponsor guidelines, industry best practices and regulatory standards.

• Coordinated the archiving of study databases and related documents.

• Followed informed consent processes and maintained records

• Maintained compliance with protocols covering patient care and clinical trial operations.

• Worked with vendors such as central laboratories in support of timelines and data-related deliverables.

CLINICAL TRIAL ASSOCIATE 02/2014 to 03/2016

IQVIA

• Performed billable project tasks to support the CRAs and Clinical Operations Leads (COLs).

• Retrieved, consolidated, and analyzed data and presented reports to the team to use in supporting operational and business objective.

• Accompanied CRAs for observational and co-monitoring support on-site or during remote visits.

• Provided administrative support to clinical operations team including scheduling meetings and calls, following up on outstanding sponsor documents, creation of site provision lists, taking minutes, and supporting overall business initiatives.

• Created site identification surveys for all phase protocols by reviewing protocol documents, sponsor feasibility and questionnaires.

• Worked closely with the clinical trial manager to analyze available data from CTMS, and other available sources to understand site study needs and patient population.

• Entered new study information into various databases.

• Generated reports from various databases to support program management needs.

EDUCATION

American Institute of Alternative Medicine, Columbus, OH

Associate of Science, Nursing

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