Abdul Chisty
Manassas,VA
Summary
Results-driven Clinical Data Management professional with 14+ years of expertise in overseeing complex studies across various therapeutic areas including oncology. A collaborative leader dedicated to promoting an engaged work culture, with a strong track record of regulatory compliance.
Seeking a challenging role to leverage mentorship skills, vendor management proficiency, and CDISC standards knowledge to contribute to innovative clinical data management strategies and drive study success while ensuring accurate and compliant data management.
Overview
12
12
years of professional experience
Work History
Associate Director, Clinical Data Management
Alira Health
09.2021 - 06.2023
- Led complex development programs across Phase 1 to Phase 4 clinical trials, aligning with company’s strategy
- Managed multiple CROs and vendors for Data Management activities from study start up through Database lock and study close which included the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks
- Ensured the collected data is clean, complete, consistent, accurate, of highest data quality and ready for submission
- Provided visionary leadership to Clinical Data Managers, providing direction, guidance, and quality oversight to team members, fostering innovation and process improvements in line with the organization’s mission
- Collaborated with cross-functional teams on key study documents, including Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, Safety Monitoring Plans, as a key member essential for the multi-disciplinary approach
- Played a pivotal role in CRO selection, vendor management, and budget proposals, aligning with company’s emphasis on vendor collaboration
- Ensured rigorous regulatory compliance and adherence to ICH/GCP guidelines, critical for company’s commitment to patient safety
- Spearheaded data quality assurance and resolved data-related issues during audits and inspections as a subject matter expert
- Enhanced and updated Standard Operating Procedures (SOPs) to meet regulatory requirements, supporting organization’s emphasis on process standardization and improvement.
Data Management Lead
Parexel
06.2019 - 09.2021
- Served as a single point of contact managing a team of 6 DMs and ensured that all data management deliverables were met per the contractual obligations and client satisfaction
- Authored and reviewed/revised the DM related study plans including Data Management Plan (DMP), Data Validation Plan (DVP), Data review plan (DRP), eCRF Completion Guidelines (CCG), and other study documents to ensure quality and standardization
- Managed virtual DM teams across time zones and cultures, fostering collaboration and supporting organization’s cross-functional approach
- Implemented process improvements and SOPs, ensuring data integrity and adherence to CDISC standards, aligning with company’s commitment to high-precision data management
- Collaborated with internal and external stakeholders for seamless trial conduct, emphasizing communication and alignment with company’s mission
- Ensured quality control, adhering to ICH, SOPs, and guidelines, critical for organization’s risk mitigation strategies
- Reviewed metrics reports regularly and tracked project scope, source data verification, query status, periodic data review and data trends supporting the company’s data-driven approach
- Coordinated and executed all DM activities with stringent quality control, essential for company’s focus on data quality.
Clinical Data Manager
HepTronik Corp.
09.2018 - 06.2019
- Coordinated overall data management activities from protocol review to database lock, ensuring robust data handling
- Organized and chaired core team meetings and review meetings, promoting cross-functional collaboration
- Collaborated with database programmers on database design and Data Validation specifications (DVS) checks, aligning with company’s emphasis on innovative data systems
- Prepared Data Management Documents and facilitated Database metrics meetings, supporting company’s focus on data-driven decision-making
- Conducted SAE Reconciliation and vendor reconciliations, critical for patient safety in company’s high-precision therapies
- Ensured timely resolution of queries and protocol deviations, supporting data quality for company’s groundbreaking treatments.
Senior Clinical Data Manager
Dammam Medical Complex
01.2014 - 05.2018
- Led and managed a team of 8 Clinical Data Managers, providing mentorship
- Developed and executed data management plans, ensuring adherence to study protocols
- Provided strategic input into the design of data flow across EDC per the protocol
- Collaborated with cross-functional teams for data analysis and reporting
- Defined and executed mitigation strategies proactively to ensure smooth submissions
- Contributed to the development and implementation of process improvements and standards
- Ensured 100% DB lock within allotted budget with zero major quality issues.
Clinical Data Manager
Dammam Medical Complex
01.2011 - 12.2013
- Provided oversight of outsourced clinical data management activities
- Managed database setup, user acceptance testing, and system validation
- Performed data review and cleaning, query management, and coding
- Identified data and system issues, and mitigate risks to data quality
- Developed data management documentation, including SOPs
- Prepared material for and participated in meetings.
Education
MBA - Health Care Administration
Sikkim Manipal University
Gangtok, Sikkim, India12.2010
M.B.B.S (Medical Doctor) - Bachelor of Medicine, Bachelor of Surgery
Karnatak University
Dharwad, Karnataka, India12.1995
Skills
- Clinical data management software proficiency (Medidata Rave, Datatrak, Datalabs, Dacima, Veeva, TrialKit, THREAD, Fountayn, eXcileCR etc)
- EDC system setup and management expertise
- Good knowledge of CDISC standards (SDTM, ADaM), medical coding dictionaries such as MedDRA and WHO Drug, and quality control processes
- Regulatory compliance (ICH GCP, 21 CFR Part 11, FDA regulations)
- Strong project management, time management, and organization skills
- Effective team leadership and collaboration, supporting team-oriented approach
- Proficient in Microsoft Office
- Multilingual with fluency in English and Arabic, Native speaker of Hindi, Urdu, and Kannada
- Clinical Data Management
- Regulatory Compliance
- CDISC Standards
- Leadership & Mentoring
- Cross-Functional Collaboration
- Vendor Management
- Risk Assessment & Mitigation
- Electronic Data Capture (EDC)
- Remote Team Management
Timeline
Associate Director, Clinical Data Management
Alira Health
09.2021 - 06.2023
Data Management Lead
Parexel
06.2019 - 09.2021
Clinical Data Manager
HepTronik Corp.
09.2018 - 06.2019
Senior Clinical Data Manager
Dammam Medical Complex
01.2014 - 05.2018
Clinical Data Manager
Dammam Medical Complex
01.2011 - 12.2013
MBA - Health Care Administration
Sikkim Manipal University
M.B.B.S (Medical Doctor) - Bachelor of Medicine, Bachelor of Surgery
Karnatak University
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