Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Databases
Timeline
Generic
IBRAHIM MOHAMMAD

IBRAHIM MOHAMMAD

Vijayawada

Summary

Project management specialist with comprehensive experience in leading projects from inception to completion. Skilled in coordinating cross-functional teams, optimizing processes for efficiency, and implementing innovative solutions to complex challenges. Proven ability to deliver projects on time and within budget while maintaining high standards of quality. Demonstrated success in enhancing operational workflows and significantly improving project outcomes through strategic planning and effective communication.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Associate Project Manager Lab Services

IQVIA LABORATORIES
Bangalore
07.2021 - Current
  • Work with pharma Companies (Sponsors), CROs (vendors) and research networks to optimize study design with the intent of creating digitally regulatory ready studies.
  • Customer's primary point of contact as a project manager for the assigned studies throughout the study lifecycle (startup, maintenance, closeout). Ensures, work is done in accordance with work instructions, eSOPs, protocol & country specific regulation.
  • Managing lab services for clinical trials, ensuring to meet all goals while maintaining smooth operations in collaboration with all cross-domain managers to meet the set milestone for the study with the help Project management team.
  • Facilitated seamless study set-up for Phase I-IV clinical trials including Protocol and Budget review, leading meetings, develop and implement project plans, work in accordance to set milestone, oversee risk issue, action logs and develop risk mitigation plan.
  • Managing study documentation throughout the Project lifecycle, including filing into eTMF electronic trail master file, and providing required in accordance with the demands of the Study Sponsor/Client requirements.
  • Managed central laboratory operations (kits/supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, site alerts, etc.) with in-house tools LIMS QLIMS/LTMS, Smartsheet’s and Labmatrix.
  • Handled study scope/protocol changes, monitored the budget signed for the study, and raised a change order with the aid of PMP tools like labBI 360, and BMT Budget Monitoring tool.
  • Coordinates customer survey follow up and ongoing health checks to support Customer relationship building and implement corrective measures as necessary.
  • Collaborated with cross-functional teams to develop innovative solutions that met customer needs.
  • Analyzed existing processes to identify areas for improvement and streamline operational efficiencies. Identified potential risks associated with assigned projects and developed mitigation strategies.
  • Prepared presentations highlighting key findings from project analysis activities. Project status presentations for delivery to customers or project personnel.
  • Provided guidance to team members throughout the life cycle of each project.
  • Facilitated team meetings to review project goals, objectives, deliverables, and timelines.
  • Tracked financial performance of assigned projects throughout their lifecycle. Submitted budget estimates, progress reports and cost tracking reports.
  • Met with stakeholders to discuss project goals and needs. Develop and track project milestones to drive on-time and within the budget project delivery.
  • Participated in professional development opportunities to stay current with industry trends and technologies.

Business Process Lead

TCS
Pune
06.2018 - 07.2021
  • EVWEB (Eudravigilance MLM) case management, CAPA management, and importing cases to workflow.
  • Develop and deliver strategies in coordination with managers to meet quality and deliver client within timelines as per agreed SLAs. Manage a Therapeutic Area Case Processing Team.
  • Monitor workload and allocate it to resources appropriately and prioritize outstanding cases (due/priority cases). Represents the drug safety case processing team at internal and external meetings, developing and implementing new techniques in pharmacovigilance activities and updates.
  • Follow up with clients regarding outstanding queries and action items for missing information with Local Safety Officers (LSO) for the completeness of the report.
  • Train new associates on case processing conventions and new updates.
  • Ensure cases are processed as per the set timelines (regulatory, partner compliance at 100%).
  • Initiate due diligence, finalization, and submission of reports to health-care authorities.

Senior Drug Safety Associate

Bioclinica
Mysore
08.2014 - 05.2018
  • Performed case Bookin/Triage, Case processing, Narrative writing, Literature review, of safety reports and handling drug safety mailbox. Quality review of ICSRs in accordance with source document.
  • Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet in accordance with Safety Data Exchange Agreement (SDEA) and Business partner Agreements and Regulatory Authorities.
  • Reconciliation of the reports processed across with partners. Tracked financial status of assigned projects and provided regular reports to Project management and clients.
  • Handling of operations mails on daily basis, performing consistency checks of labeling, Reviewing Targeted Follow-up Questionnaires (TFUQs) generated and quality checks on daily basis and provide feedback to the team member for the errors noted.
  • Trained to review XML files, importing cases to workflow, EVWEB (Eudravigilance MLM) and Literature search and review (Embase). Performing abstract/ full article triage for case.
  • Attend client budget calls and study follow-up meetings for process updates and train new associates regarding case processing activities and latest sponsor updates.
  • Collaborated with internal departments to ensure compliance with global drug safety regulations and guidelines.

Education

Doctor of Pharmacy -

JSS College Of Pharmacy
Mysore
05-2014

Skills

  • Project planning and management
  • Development milestone planning
  • Risk management
  • Resource utilization planning
  • Root-cause analysis
  • Client relationships

Accomplishments

• Received Ovation award for year 2021, 2023 and 2024.

• Received star performer title on numerous occasions during my tenure with TCS.

• Received the title of “Obelisk” for the year 2015.

Certification

• Lean Six Sigma fundamentals.

• Project Management LinkedIn certification

Databases

  • ARGUS (Oracle)
  • Aris-G
  • CDSCO
  • CTMS (LTMS & NewLims)
  • Project management Tools: Power BI, Lab Matrix, BMT

Timeline

Associate Project Manager Lab Services

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

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IBRAHIM MOHAMMAD