Project Manager Management

Shameema Ahmed

*************@*****.*** 626-***-****

BACKGROUND

Highly motivated and results-driven Clinical Project Manager with over 12 years of experience managing early-phase (First-in- Human) through late-phase global clinical trials. Proven expertise in leading complex, multi-regional studies across a broad range of therapeutic areas including psychiatry (depression, anxiety), neurology (migraine), dermatology (psoriasis), respiratory (asthma, bronchitis), endocrinology (diabetes), neonatology, and musculoskeletal (osteoarthritis). Brings 8–10 years of specialized oncology experience, with deep involvement in cutting-edge modalities such as immunotherapy, gene therapy, and CAR-T. Certified in Project Management, with a strong foundation in clinical operations, vendor oversight, and cross- functional team leadership. Proficient in clinical data analysis and process optimization, passionate about driving innovation and operational excellence in clinical development. Recognized for delivering high-quality trials on time and within budget, while fostering collaborative team environments and maintaining regulatory compliance. PROFESSIONAL EXPERIENCE

Senior Project Manager, Immunocore – Contract (Feb 2024 – Mar 2025)

• Provided overall leadership and oversight for study execution across all phases.

• Delivered training to study team members and clinical sites to ensure protocol adherence.

• Led and coordinated Dose Level Review meetings; communicated key decisions and operationalized review outcomes.

• Directed strategic planning for early-phase clinical operations, contributing to clinical development plans.

• Developed and managed study timelines, clinical protocols, and informed consent forms (ICFs).

• Contributed to and reviewed study documentation, including monitoring plans, risk management tools, eCRFs, training materials, manuals, safety and regulatory documents, and Clinical Study Reports (CSRs).

• Led site selection efforts in collaboration with the clinical study team.

• Oversaw day-to-day global trial operations, resolving escalated issues from regional study teams.

• Maintained close collaboration with investigators via regular and ad hoc site meetings.

• Oversaw and managed vendor performance throughout the study lifecycle. Assistant Director, Clinical Project Management, CTI Clinical Trial & Consulting Services (Apr2022 – Jan2024)

• Strategically planned, executed, and evaluated the full lifecycle of multiple global clinical trials, overseeing projects from initial planning through data analysis and final delivery to clients. Frequently served as Global Lead, ensuring alignment across international teams.

• Ensured all operational activities adhered to ICH-GCP, regulatory guidelines, and trial-specific procedures, maintaining full compliance across functional areas.

• Oversaw and guided Clinical Project Managers (CPMs) and Clinical Project Coordinators (CPCs), ensuring seamless coordination between internal teams, external stakeholders, and sponsors throughout the study lifecycle.

• Acted as the primary senior contact for both CTI Executive Management and sponsor leadership, providing strategic client management, proactively mitigating risks, and resolving complex issues efficiently.

• Collaborated on the development of comprehensive project plans and timelines; continuously monitored progress and implemented solutions to address schedule delays, budget constraints, and resourcing challenges.

• Assessed resource requirements in partnership with functional leaders; assembled and managed cross-functional project teams to ensure operational excellence and balanced workloads.

• Utilized robust project management tools to track milestones, metrics, and deliverables; ensured timely and accurate data entry and visibility for all stakeholders.

• Led training initiatives for assigned project teams and provided hands-on guidance tailored to team member experience and project complexity.

• Reviewed scope of work (SOW) to ensure alignment with contractual obligations; collaborated with Business Operations to manage change orders and contract amendments effectively.

• Analyzed and synthesized project data, tracking progress against key milestones and client expectations; escalated risks as needed and partnered with CPMs to drive corrective actions.

• Reviewed and approved project status reports and all sponsor-facing deliverables, ensuring they met quality standards and accurately reflected project health.

• Provided regular updates on project progress, resourcing, risks, and scope to Executive Management, maintaining transparency and accountability.

• Delivered hands-on mentorship and coaching to CPMs, fostering independence, strengthening project leadership capabilities, and supporting professional development.

• Evaluated internal and external QA findings for assigned trials, ensuring prompt and effective implementation of corrective and preventive action plans.

• Played a leadership role in process improvement initiatives, contributing to the development of more efficient workflows, SOPs, and cross-functional collaboration strategies.

• Shared deep operational expertise with clinical teams; led the creation of knowledge resources and best practices for broader clinical operations use.

• Served as a key mentor and trainer in project management methodology, leadership development, and cross-functional team success.

Global Early Clinical Development Manager, Amgen (Nov 2021 – Apr 2022)

• Effectively trained study team members and clinical sites to ensure accurate and compliant study conduct.

• Led and coordinated Dose Level Review (DLR) meetings, communicated key outcomes, and successfully translated decisions into actionable clinical operations strategies.

• Spearheaded early-phase clinical operations planning and contributed to strategic scenario development within the broader clinical development plan.

• Developed and maintained comprehensive study timelines and played a key role in authoring clinical protocols and informed consent documents.

• Provided critical input into the development and/or review of essential study documentation, including monitoring plans, risk management tools, eCRFs, operational manuals, training materials, regulatory submissions, and clinical study reports.

• Directed clinical study team efforts in identifying, evaluating, and selecting high-performing clinical sites.

• Oversaw daily global trial operations and efficiently resolved escalated issues from local study teams to maintain study integrity and timelines.

• Fostered strong, ongoing collaboration with site investigators through regular and ad hoc meetings, ensuring alignment and seamless communication of key decisions and outcomes.

• Managed vendor and functional service provider (FSP) relationships to ensure deliverables met quality, timeline, and budget expectations.

Senior Project Manager, ICON LLC (Aug 2019 – Nov 2021)

• Directed and coordinated cross-functional project teams to ensure timely achievement of study milestones, proactively addressing operational challenges and removing obstacles to success.

• Promoted consistency and compliance by standardizing the use of study tools and training materials; drove continuous process improvements across assigned projects.

• Monitored quality metrics through site communications, monitoring reports, data trends, and QA audits to identify risks and implement effective corrective and preventive actions; escalated critical issues as appropriate.

• Developed and delivered clear, concise project updates and strategic insights in both internal and client-facing meetings.

• Played a key role in proposal development and frequently led bid defense presentations in collaboration with Business Development and senior project leadership.

• Allocated project workloads, defined team roles, and oversaw the upkeep of internal databases and comprehensive project plans to ensure accuracy and transparency.

Senior Project Manager, Clinical Operations, Syneos Health (Supporting BMS Clinical Division) (Jul 2017 – Jul 2019)

• Provided strategic oversight of interdisciplinary clinical research programs, ensuring alignment with client expectations, timelines, and regulatory requirements.

• Acted as the primary representative of Syneos Health to sponsors, maintaining strong client relationships, driving satisfaction, and ensuring the effective communication of program objectives and deliverables.

• Led high-performing clinical teams, ensuring consistent delivery of projects on time, within budget, and to the highest quality standards.

• Owned the Trial Master File (TMF) Management Plan and ensured its accuracy, completeness, and inspection readiness across assigned projects.

• Held full accountability for the financial health of each assigned project, closely monitoring budgets, resource utilization, and financial forecasting.

• Managed the end-to-end delivery of project milestones, ensuring all clinical, regulatory, and operational deliverables met agreed timelines and quality benchmarks.

• Ensured rigorous compliance with GCP, SOPs, and global regulatory requirements, fostering a culture of quality and audit readiness.

• Maintained accurate and up-to-date study information across all relevant systems and databases, ensuring data integrity and traceability.

• Led the planning and execution of inspection-readiness activities, preparing teams and documentation to support successful regulatory inspections.

• Directed the development, execution, and maintenance of detailed project plans, aligning functional teams and resources with study objectives.

• Coordinated and presented critical project updates and risk assessments during internal and external meetings with sponsors and stakeholders.

• Generated high-quality project management reports to communicate progress, risks, and mitigation strategies to both clients and senior management.

• Developed and implemented resource allocation strategies to meet project needs and optimize team performance.

• Designed and executed contingency planning and risk mitigation strategies, ensuring uninterrupted progress and the successful delivery of study outcomes.

• Participated in bid defense meetings, and regularly presented as the proposed Project Manager or Project Director to prospective clients.

• Supported business development by reviewing proposal content, pricing, and study assumptions, contributing operational insights and feasibility perspectives during the proposal process. Senior Project Manager, Covance Inc. (Jun 2016 – Jun 2017)

• Successfully led and managed domestic, regional, and global clinical trials across multiple therapeutic areas, ensuring seamless execution from start to finish.

• Conducted comprehensive RBM (Risk-Based Monitoring) dashboard reviews and initial study risk assessments to proactively identify and address operational risks.

• Monitored team performance against contractual obligations, client expectations, and project baselines; regularly reported outcomes and KPIs to senior management.

• Took the lead in issue resolution and risk management, developing and implementing robust contingency plans to ensure study continuity and mitigate clinical risks.

• Identified and resolved quality concerns by thoroughly analyzing site communications, monitoring reports, data flow, and QA audit findings; escalated critical issues with clear corrective action plans.

• Collaborated cross-functionally with internal teams and external stakeholders to drive milestone achievement and resolve complex project obstacles.

• Oversaw the development and management of detailed project budgets, timelines, and quality standards, ensuring deliverables were consistently met while controlling scope and risk.

• Compiled, maintained, and ensured the integrity of all regulatory and study documentation, driving compliance and readiness for audits or inspections; took on line management duties when required.

• Led the core project team and empowered extended team leadership, flexibly partnering with Senior Project Managers and Project Directors depending on project size and complexity.

• Contributed operational insight to new business proposals and project budgets, aligning feasibility and timelines with client expectations.

• Delivered impactful presentations and strategic updates in internal and external meetings, enhancing stakeholder engagement and project visibility.

• Actively participated in proposal development and frequently led bid defense presentations alongside Business Development and Senior Clinical Project Management leadership. Senior Project Manager, IQVIA (May 2015 – Jun 2016)

• Successfully managed high-profile client projects with full accountability for on-time, on-budget, and within-scope delivery, ensuring alignment with client expectations and strategic objectives.

• Oversaw all project phases from initiation to close-out, establishing clear timelines, delegating responsibilities, and actively monitoring and summarizing project progress to drive milestone achievement.

• Delivered regular, data-driven project status reports and strategic insights to executive leadership, ensuring full transparency and proactive issue resolution.

• Acted as the primary client liaison, fostering strong sponsor relationships and ensuring deliverables consistently met contractual scope, timelines, and budgetary parameters.

• Collaborated cross-functionally with internal departments to ensure integrated execution and operational harmony across all project components; recruited and onboarded new team members as needed to meet evolving project demands.

• Championed the consistent use of standardized tools, templates, and training materials to ensure compliance with internal SOPs, regulatory guidelines, and best practices.

• Developed comprehensive study management plans, defined team responsibilities, and ensured effective oversight of database maintenance and study documentation.

• Served as the primary point of contact for sponsors, ensuring open, effective communication and building lasting partnerships through responsiveness and operational excellence.

• Drove team performance and quality through strategic planning of co-monitoring visits and continuous mentorship of Clinical Research Associates (CRAs), enhancing site support and compliance.

• Delivered clear, impactful project presentations during internal team updates and external stakeholder meetings, strengthening engagement and alignment.

• Actively contributed to proposal development, offering operational insights to strengthen bid strategies and feasibility assessments.

• Regularly led bid defense presentations in collaboration with Business Development and senior project leadership, demonstrating deep operational expertise and client-focused solutions. Senior Site Manager, PAREXEL International (2011 – 2015)

• Oversaw all administrative and operational functions of the CRO, including team staffing, daily scheduling, and development of budgets for regulatory submissions and contract terms.

• Led the development of clinical trial documents, including study protocols, Manuals of Operations, Statistical Analysis Plans (SAPs), and trial designs for investigator-initiated Phase II and III studies.

• Directed the preparation and submission of regulatory documents such as IDEs, INDs, and paper submissions to support investigator- sponsored clinical research.

• Managed multiple clinical trial sites, ensuring full compliance with study protocols and regulatory standards across all phases of study conduct.

• Took ownership of internal audit resolution processes, driving timely corrective actions and ensuring audit readiness.

• Reviewed monitoring trip reports and provided oversight and performance management for Clinical Trial Specialists (CTS), Clinical Monitoring Associates (CMA), and Clinical Research Associates (CRAs).

• Collaborated closely with the Director to maintain and revise project plans based on evolving study needs and priorities.

• Maintained direct and ongoing communication with study sponsors, providing weekly updates on site performance, enrollment, and key milestones.

• Authored and reviewed a wide range of project-specific documents, ensuring consistency, accuracy, and regulatory compliance.

• Acted as the primary liaison between clinical sites and sponsors, facilitating seamless communication and issue resolution throughout the trial lifecycle.

• Actively participated in and presented at both internal team meetings and external sponsor-facing meetings to align objectives and drive project success.

• Supported project resourcing activities by assessing staffing needs, reallocating personnel, and ensuring the right expertise was available at each study stage.

EDUCATIONAL BACKGROUND

MD, Medical Surgery

Rangpur Medical College, Rangpur, Banglades h

Higher Secondary School Certificate

Mymensingh Girls’ Cadet College, Mymensingh, Banglades h LICENSURE AND RELEVANT CERTIFICATIONS

Fundamentals of Project Management – Barnett International THERAPEUTIC EXPERIENCE

Cardiology Respiratory Dermatology Neurology Rare Diseases Medical Devices Infectious Diseases Endocrinology/Metabolism (Diabetes, Hyperlipidemia ) Oncology (Breast, GI/GU, Solid Tumors) Ophthalmology LANGUAGES

English, Bangla

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