Sumaiya Karim
Northville,MI
Summary
Seasoned healthcare professional with over 12 years of experience in successfully delivering complex clinical projects, overseeing clinical affairs, quality control, and business operations, all while aligning project goals with overarching business objectives. Ensure compliance while consistently delivering projects on time and within scope. Expertise in multi-phase clinical trials (Phase I-IV) and drug development through regulatory approval. Strong leader, skilled in collaborating with CROs, vendors, regulatory bodies, and senior leadership to enhance efficiency, mitigate risks, and implement process improvements. Focused on advancing patient care and accelerating the development of life-saving therapies.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Project Manager I
MMS Holdings
Canton, MI
07.2022 - Current
- Accomplish timely project delivery and budget adherence by efficiently managing all phases of the project from initiation to close-out, ensuring action tracking, risk management, and scope control
- Secure long-term account growth and revenue by identifying emerging client needs and service opportunities, contributing to sustained business expansion and client loyalty
- Reduce project risks and disruptions by proactively identifying potential challenges and collaborating with the team to implement process improvements that kept projects on track
- Ensure financial success of projects by developing and managing accurate budgets, payment schedules, and revenue forecasts, effectively handling scope changes while consistently meeting financial goals
- Enhance client satisfaction and retention by exceeding expectations, ensuring transparent communication, and upholding strict adherence to SOPs, leading to stronger long-term client relationships
- Foster high team performance by recognizing individual contributions, motivating team members, and driving a collaborative culture that resulted in successful project outcomes
Senior Project Management Associate II
MMS Holdings
Canton, MI
08.2021 - 07.2022
- Achieved project milestones on schedule by developing and maintaining complex MS Project timelines, ensuring alignment with both internal and sponsor team objectives for successful project delivery
- Steered project efficiency improvements by identifying challenges and proactively suggesting constructive solutions, leading to enhanced processes and overall success
- Maximized meeting productivity by effectively coordinating schedules across time zones, developing focused agendas, and ensuring clear communication of actions and decisions, driving alignment and progress
- Ensured precise and timely client billing by leveraging a deep understanding of MMS pricing models and billing procedures, resulting in accurate invoicing and smooth financial operations
Senior Project Management Associate I
MMS Holdings
Canton, MI
09.2019 - 07.2021
- Streamlined submission processes by collaborating with the MMS Submissions Initiative Team to create innovative templates and tools, resulting in more efficient IND/NDA/MAA submissions
- Spearheaded the successful MAA submission and provided critical support for the NDA in the CDKL5 Deficiency project, accelerating the timeline for regulatory approvals
Project Management Associate
MMS Holdings
Canton, MI
05.2018 - 08.2019
- Fostered stronger client partnerships by proactively aligning expectations with company standards and ensuring seamless adherence to established procedures, driving long-term client loyalty and satisfaction
- Ensured project continuity and success by anticipating potential risks early on and collaborating with teams to implement timely corrective actions, effectively preventing major issues and keeping the project on track
Clinical Affairs Manager
Abbott Diagnostics Division
Irving, TX
05.2016 - 02.2018
- Ensured strict adherence to regulations by managing delegation oversight audits, meeting all federal and state reporting obligations, and developing comprehensive protocol summaries to support compliance
- Delivered valuable clinical insights by thoroughly analyzing data, preparing protocol synopses, and crafting detailed clinical reports, leading to informed project decisions and improved outcomes
- Enhanced deliverable quality and accuracy by reviewing all documentation to ensure technical precision, maintaining high standards of compliance, and ensuring optimal client satisfaction
- Improved organizational compliance by overseeing staff training and ensuring alignment with credentialing procedures and health plan policies, fostering operational consistency
- Maintained top-tier lab safety by conducting rigorous safety checks on biohazards and ensuring laboratory facilities met Good Laboratory Practices, promoting a secure and compliant working environment
Quality Control
Alcon Laboratories
Fort Worth, TX
05.2015 - 04.2016
- Maximized data reliability by performing comprehensive QA testing, validating experimental data samples, and delivering insights to guide impactful recommendations and decision-making
- Streamlined data handling by utilizing MS Access and proprietary database systems, ensuring the accurate organization and easy retrieval of documentation to support ongoing operations
- Maintained alignment with goals by actively participating in QA Committee meetings, tracking progress, and swiftly addressing any obstacles, ensuring timely completion of departmental objectives
- Optimized material availability by efficiently managing chemical and raw material stocks, ensuring timely ordering and replenishment of new products to maintain uninterrupted operations
- Enhanced lab efficiency by managing the preparation of chemicals and media, supporting R&D and QC Microbiology Lab workflows for consistent and reliable testing results
- Ensured equipment precision by operating, maintaining, and calibrating diagnostic instruments and machinery, guaranteeing reliable functionality for accurate research outcomes
HR Specialist (Contract)
Tenet Healthcare Corp.
Dallas, TX
01.2015 - 03.2015
- Conducted HR management support in recruitment, background checks, on-boarding orientations, and
developed new rewards and benefits programs that motivate employees - Handled personnel administration and executed HR policies and performance metrics
Business Operations Manager
Saint Joseph Hospice
Irving, TX
05.2013 - 08.2014
- Drove cost reductions and improved resource utilization by implementing targeted strategies for resource allocation and optimizing medical inventory processes, significantly boosting overall efficiency
- Supported a remarkable 800% increase in patient volume by developing precise revenue forecasts and reliable budgets, while refining processes to improve operational scalability and financial accuracy
- Ensured compliance by maintaining all necessary licensure and certifications (Medical License, DPS, DEA), and rigorously adhering to health plan policies, NCQA, TDI, and CMS regulations, preventing any compliance breaches
- Eliminated operational inefficiencies by conducting thorough business performance analysis and implementing targeted solutions, resolving key administrative issues and enhancing workflow processes
- Optimized reporting systems and operational practices by enhancing procedures for reporting, updating control forms, and improving record-keeping systems, leading to more streamlined data management and better decision-making
- Improved provider onboarding and data accuracy by overseeing the processing of provider applications and maintaining a robust provider profiling system, ensuring accurate and timely updates for the team
- Improved staffing efficiency by leading recruitment, screening, and training for new hires, volunteers, and interns, ensuring the right talent was brought in to meet organizational needs and objectives
Administrative Intern
Victory Five Healthcare
Irving, TX
01.2013 - 05.2013
- Assisted with business planning and healthcare financial management such as medical billing/ insurance
- Provided administrative support such as scheduling phone interviews and creating interview packets for
hiring managers
Sales and Marketing Representative
Princeton Review
Arlington, TX
09.2010 - 08.2012
- Developed marketing and sales programs and campaigns to promote enrollment in preparatory classes and services
- Performed market and sales planning, market research, advertising, public relations, event management,
product development, and distribution/ channel marketing - Coordinated the execution of PR campaigns, social media presence, community events, and activities of the
Science Constituency Council
Education
M.A. - Healthcare Management
Dallas Baptist University
05-2015
B.S. - Major in Biology, Minor in Communication
University of Texas At Arlington
05-2012
Associates - Liberal Arts and Sciences
Tarrant County Community College
05-2009
Skills
- Healthcare Project Management
- Clinical Trial Management
- Regulatory Affairs & Compliance Management
- Project Lifecycle Management
- Scope Definition & Project Planning
- Change Management
- Budget & Resource Allocation
- Risk Identification & Mitigation
- Project Scheduling
- Team Leadership
- Stakeholder Engagement & Communication
- Client Relationship Management
- Vendor & CRO Management
- Contract Negotiation & Vendor Selection
- Regulatory Submissions & Compliance (FDA, EMA, ICH-GCP)
- Clinical Trial Design & Execution (Phase I-IV)
- Drug Development Lifecycle Management
- Quality Assurance & Control
- Process Improvement & Operational Efficiency
- Data Analysis & Reporting
- Performance Metrics Tracking & KPI Reporting
- Forecasting & Strategic Planning
- Supply Chain & Logistics Coordination
- Clinical Data Management & Integrity
- Regulatory Document Preparation & Review
- Continuous Improvement Initiatives
- Talent Development & Team Mentoring
- Issue Resolution
Certification
Project Management Skills for Leaders
Key Value Offerings
- Regulatory Expertise – Leading IND and Marketing Application submissions for compliance and approvals.
- Project Leadership – Driving projects with a focus on timelines, budgets, and risk management.
- Cross-Functional Management – Aligning clinical, regulatory, and operations teams for success.
- Process Optimization – Enhancing workflows and resource efficiency for better outcomes.
- Client Engagement – Building strong relationships for collaboration and long-term growth.
- Industry Experience – Navigating CRO, pharma, biotech, and healthcare with strategic insight.
Timeline
Project Manager I
MMS Holdings
07.2022 - Current
Senior Project Management Associate II
MMS Holdings
08.2021 - 07.2022
Senior Project Management Associate I
MMS Holdings
09.2019 - 07.2021
Project Management Associate
MMS Holdings
05.2018 - 08.2019
Clinical Affairs Manager
Abbott Diagnostics Division
05.2016 - 02.2018
Quality Control
Alcon Laboratories
05.2015 - 04.2016
HR Specialist (Contract)
Tenet Healthcare Corp.
01.2015 - 03.2015
Business Operations Manager
Saint Joseph Hospice
05.2013 - 08.2014
Administrative Intern
Victory Five Healthcare
01.2013 - 05.2013
Sales and Marketing Representative
Princeton Review
09.2010 - 08.2012
M.A. - Healthcare Management
Dallas Baptist University
B.S. - Major in Biology, Minor in Communication
University of Texas At Arlington
Associates - Liberal Arts and Sciences
Tarrant County Community College
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