Clinical Trail Management
Clinical research
Project Management
Ibrahim Mohammad
Vijayawada,India
Summary
Results-driven project management professional with extensive experience in overseeing project timelines, resources, and stakeholder communication. Proven track record of delivering projects on schedule and within budget while upholding high standards of quality. Consistently meeting deadlines, optimizing resources, fostering collaboration, and adapting seamlessly to dynamic environments. Expertise in project planning, risk assessment, and ensuring successful project delivery that enhances client satisfaction.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Associate Project Manager
IQVIA LABORATORIES
07.2021 - Current
- As a Global Project Manager act as the primary contact for sponsors, vendors, and TPOs throughout the project lifecycle, ensuring effective communication and coordination at every stage.
- Manage Phase I-IV clinical trial setup and monitoring, oversee budgets, reconcile vendor data, track milestones, resolve action items, maintain logs, plan for risks, and document lessons learned.
- Supervise lab logistics, kit distribution, specimen storage, data reporting, and workflows using tools like CTMS, LIMS, Smartsheet, Power BI, and Labmatrix.
- Review, finalize, and file study documents in client-specific eTMF systems to guarantee compliance and accessibility.
- Work with different teams to provide tailored solutions and regular project updates.
- Worked on User Acceptance Testing (UAT) by planning and executing test cases, verifying software tools/applications met business needs, and documenting results. Worked with stakeholders to confirm system functionality and resolve defects before deployment.
- Monitor study progress, manage changes via control processes, and achieve key milestones including FPFV, LPLV, and database dry runs.
- Train and mentor study team members regionally and globally, guiding them in study monitoring and problem-solving to ensure quality results.
Business Process Lead
TCS
06.2018 - 07.2021
- Developed and executed strategies to ensure delivery of client requirements.
- Case workflow management, allocating cases to available resources and prioritizing critical and outstanding cases. Improved efficiency of drug safety operations
- Represented case processing team during internal and external meetings.
- Coordinated follow-ups with clients and Local Safety Officers (LSOs) to resolve outstanding queries and ensure completeness of case reports.
- Evaluated individual performance for annual appraisals and facilitated rating discussions.
- Conducted error trend analysis for case quality metrics and led training sessions to enhance team proficiency in case processing conventions.
- Facilitated workshops to identify areas for continuous improvement in existing workflows.
Senior Drug Safety Associate
Bioclinica
08.2014 - 05.2018
- Review of case reports, accessing seriousness criteria of the report, triage/case book-in, case processing, narrative writing, literature review, including oversight of the drug safety mailbox.
- Evaluated the reportability of Individual Case Safety Reports (ICSRs) for business partners and regulatory submissions, ensuring compliance with the Safety Data Exchange Agreement (SDEA).
- Managed operational safety mailbox for workflow management and case assignment, while conducting quality control (QC) reviews of cases triaged.
- Performed partner report reconciliations, tracked financial status of assigned projects, and provided regular reports to project management and clients.
- Trained in XML file review, case imports to workflow systems, EVWEB (Eudravigilance MLM), and literature searches/reviews using Embase.
- Collaborated with TransPerfect vendor to maintain translation service logs and budget activities within the project, utilizing vendor data sheets for accuracy.
Education
Doctor of Pharmacy -
JSS College Of Pharmacy
Mysore, India05.2014
Skills
- Project planning and management
- Data Reconciliation
- Risk management
- Resource utilization planning
- Root-cause analysis
- Client relationships
Certification
- Certified PMI Project Management Professional
- Lean Six Sigma fundamentals
Interests
Timeline
Associate Project Manager
IQVIA LABORATORIES
07.2021 - Current
Business Process Lead
TCS
06.2018 - 07.2021
Senior Drug Safety Associate
Bioclinica
08.2014 - 05.2018
Doctor of Pharmacy -
JSS College Of Pharmacy
Accomplishments
I earned the “Ovation” Award in 2021, 2023, and 2024 for outstanding contributions for my assigned projects
During my time at TCS, I was repeatedly recognized as a “Star Performer” for consistently delivering high-quality case processing and workflow management.
In 2015, I received the “Obelisk” title, acknowledging contribution for process improvisation
DATABASES
- PV databases: CDSCO, ARGUS and ArisG
- Clinical Trail Management Systems: LTMS & NewLims
- Project management Tools: Power BI, Lab Matrix, Smartsheet, MS projects, Trail master file (TMF), DocuSign
- ALM Application Lifecycle Management
DECLARATION
I hereby declare that all the information given above is true to my knowledge. All the documents in original/attested copies will be produced whenever required.