Project Management Clinical

Shameema Ahmed, MD

*************@*****.***

cell: 626-***-****

20+ years in the research industry working in first in human to late phase studies. Certification in project management and wide range of therapeutic indication. Have experience in global studies in various indications such as Depression, Anxiety, Migraine, Psoriasis, Asthma, Bronchitis, Diabetes, and osteoarthritis. 8-10 years of experience in oncology including immunotherapy, gene therapy, CAR-T.

Professional Experience

CTI Clinical Trial & Consulting Services (Apr2022 – Present)

Assistant Director, Clinical Project Management

Plans implements, facilitates, and evaluates the full execution of assigned clinical trials; oversees management of multiple clinical trials from the planning phase to the analysis phase for delivery to client; may function as a global lead

Ensures the operational aspects of the functional areas comply with International Council of Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, and trial procedures

Ensures that assigned Clinical Project Managers (CPM) and/or Clinical Project Coordinators (CPC) coordinate the organization and implementation of a clinical trial and manages the activities between all functional areas and the client on assigned trials

Serves as primary senior interface on the project with Executive Management at CTI and the sponsor; provide effective client management to prevent and mitigate trial issues; escalates identified trial, CPM, or CTI issues to Executive Management as needed; actively participates in resolution activities

Oversees preparation of the Project Plan and project timelines and monitors against project progress; ensures project activities comply with trial plans; provides suggestions and implements alternative solutions to problems with project timelines, schedules, resources, budgets, etc.; takes corrective action where necessary

Assesses resource needs with functional area managers and establishes appropriate project team in conjunction with CPM (if applicable); monitors ongoing resource needs for project

Ensures that appropriate project management tools are used to track and report project progress and metrics; ensures timely entry of project information by all team members throughout the life of the project

Ensures training of assigned project teams; participates in staff training dependent upon needs and expertise

Oversees the management of budgeted hours by the CPM, who evaluates and manages regional project budget against project milestones; ensures that the CPM takes corrective measures where necessary to keep project in line with budget expectations

Ensures that the CPM assesses scope of work (SOW) against client contractual agreements and assists in changes of scope orders; provides review of changes in scope notifications and works with Business Operations to ensure completion of needed contract amendments

Synthesizes and analyzes project information related to trial milestones in contacts and the sponsor expectations and reports the outcomes of that analysis to CTI Executive Management and the client; ensures that the CPM initiates corrective action as necessary

Conducts or attends trial team and sponsor meetings; ensures that agendas and minutes are effectively prepared to facilitate trial communication and documentation of trial oversight, discussions, and decisions

Professional Experience continued

Reviews weekly and/or monthly project status reports (MSRs) prior to forwarding to client and assures the quality of those reports, as well as all other sponsor deliverables.

Reports project progress, issues, and scope of work considerations to Executive Management

Provides input for new business development (NBD) proposals, assists in project budget preparation / reviews, and represents project management services during NBD client presentations; participates in business recruitment and marketing activities; seeks NBD opportunities when appropriate and communicates these opportunities to Business Development (BD)

Provides supervision, guidance, and mentoring to CPMs while encouraging independence and refining skills of the CPMs.

Reviews and assesses internal and external quality assurance (QA) reports for assigned projects and ensures corrective action as necessary by the project management team.

Provides leadership in process improvement activities and initiatives.

Provides leadership and shares expertise with clinical operations staff; facilitates the development of reference and resource materials for CPMs and clinical operations.

Effectively coaches and trains others in the CPM practices as well as professional development.

Amgen (Nov2021 – Apr 2022)

Global Early Clinical Development Manager

Led study level planning of the overall clinical operation results.

Developed early phase clinical operation strategy and contributed to the strategic scenario planning in clinical development plan

Developed and maintained study timeline and development of clinical protocol and informed consent

Contributed to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials, safety and regulatory documents, and clinical study report, etc.

Led clinical study team to identify, evaluate and select clinical sites

Handled the day-to-day operations of clinical trial at a global level and resolved issues escalated by the local study team

Maintained close collaboration with site investigators through regular and ad hoc investigator and site meetings, keeping investigators, often including key thought leaders, engaged to the study

Trained study team members and/or sites to conduct the study

Led and coordinated Dose Level Review meetings, communicates decisions of the meetings, and operationalize Dose Level Review meeting outcomes.

Managed vendors and functional service providers (FSP)

ICON LLC (Aug 2019 – Nov 2021)

Senior Project Manager

Managed and coordinated efforts of cross-functional project teams to support milestone achievement and managed study issues and obstacles.

Professional Experience continued

Ensured consistent use of study tools and training materials and compliance with standard processes, policies, and procedures. Implemented continuous improvement activities for assigned project

Identified quality issues within the study through regular review of site communications, monitoring visit reports, data flow information, and QA audit findings to implement appropriate corrective action plans. Escalated findings and action plans to appropriate parties

Prepared and presented project information at internal and external meetings

Participated in proposal development. May lead bid defense presentations in partnership with BD and Senior Clinical Project Management staff

Defined project workloads and assignments. Developed and oversaw maintenance of internal databases and project plans.

Syneos Health (providing services to BMS, Clinical Division) (Jul 2017 – Jul 2019)

Senior Project Manager, Clinical Operations

Oversaw interdisciplinary clinical research programs

Represented Syneos Health to the customer, ensuring satisfaction levels were maintained and program deliverables were communicated effectively

Led clinical team to ensure quality, timelines, and budget management

Responsible for TMF Management Plan, quality, and completeness of TMF for assigned projects

Accountable for the financial performance of each project assignment

Accountable for all project deliverables for each project assigned

Ensured studies were conducted in compliance with GCP, relevant SOPs, and regulatory requirements

Accountable for maintenance of study information on a variety of databases and systems

Responsible for study management components of inspection readiness for all aspects of the study conduct

Oversight for development and implementation of project plans

Planned, coordinated, and presented at internal and external meetings

Prepared project management reports for clients and management

Implemented resource strategies to achieve project goals

Developed contingency planning and risk mitigation strategies to ensure successful delivery of study goals

Participated in bid defense meetings where was presented as potential project manager/director

Supported proposal development through review of proposal text and pricing where was presented as potential project manager

Convance Inc. (Jun 2016 – Jun 2017)

Contract

Senior Project Manager

Project Manager oversaw and managed domestic, regional, and international clinical trials

RBM dashboard review and initial study risk assessment

Reported on team performance against contract, customer expectations, and project baselines to management

Professional Experience continued

Led problem solving and resolution efforts to include management of risk, contingencies, and issues. Developed proactive contingency plans to mitigate clinical risk

Identified quality issues within the study through regular review of site communications, monitoring visit reports, data flow information, and QA audit findings to implement appropriate corrective action plans. Escalated findings and action plans to appropriate parties

Collaborated with other functional groups within the company where necessary to support milestone achievement and managed study issues and obstacles

Responsibilities typically included developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations were met while identifying and mitigating risks

Project Manager also compiled and drove documentation for the project, ensuring the accuracy and quality of regulatory data. Project Manager may have had line management responsibilities

Led core project team and facilitated team’s ability to lead extended/complete project team. Depending on size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director

Provided input for the development of proposals for new work and project budgets

Prepared and presented project information at internal and external meetings

Participate in proposal development. May lead bid defense presentations in partnership with BD and Senior Clinical Project Management staff

IQVIA (May2015 – Jun2016)

Contract

Senior Project Manager

Managed key client projects. Project Management responsibilities included the coordination and completion of projects on time, within budget, and within scope

Oversaw all aspects of project. Set deadlines, assigned responsibilities, and monitored and summarized progress of project

Prepared reports for upper management regarding status of project

Worked directly with clients to ensure deliverables fell within the applicable scope and budget

Coordinated with other departments to ensure all aspects of each project were compatible and would hire new talent as needed to fulfill client needs

Ensured consistent use of study tools and training materials and compliance with standard processes, policies, and procedures. Implemented continuous improvement activities for assigned projects

Developed study management plans, together with team assignments and accountabilities and oversight of database maintenance

Served as primary project contact with Sponsor to ensure communication was maintained and continuously improved

Ensured high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team

Prepared and presented project information at internal and external meetings

Participated in proposal development

Led bid defense presentations in partnership with BD and Senior Clinical Project Management staff

Professional Experience continued

PAREXEL Intl. (2011 – 2015)

Senior Site Manager

Managed all administrative functions of the CRO, including coordination of staffing, scheduling of day-to-day activities, as well as developed budgets for regulatory development and contract terms for the CRO. In charge of writing protocols, Manuals of Operations, Statistical Analysis Plans, and clinical trial design in Investigator initiated studies

Executed preparation processes of various regulatory functions including IDEs, INDs, and paper submissions to support investigator-sponsored studies

Managed multiple sites, conducted Phase II and III clinical trials in all aspects

Responsible for Internal Audit Resolution

Reviewed trip reports and managed CTS, CMA, and CRAs

Worked with the Director to update project plans

Communicated directly with the Sponsor for weekly update

Developed and reviewed project specific documents

Worked as a liaison between the site and Sponsor

Participated and presented in internal and external meetings

Involved in resourcing for the project

National Institute of Health/National Cancer Institute (2011)

Contract

Clinical Project Lead

Monitored site activities

Managed study specific vendors

Managed the conduct of assigned clinical investigations and activities associated with clinical trials

Managed the interaction of appropriate departments and staff to support and maintain the clinical investigations

Worked as a line manager for CRAs and CTAs including hiring and reviewing their performance and monitoring reports

Supervised training programs to assure consistency and compliance in monitoring of clinical investigations

Assisted with preparation of department budgets, timelines, and project plans

Negotiated contracts and budgets for assigned clinical investigators and vendor

Worked in the DMC board, actively participated in AW, SAE initial reporting, follow-up, narrative writing, and resolution. Worked with the Medical Monitor for the patient safety review

MAP Pharmaceuticals, Inc. (Biotech Organization focused on inhaled devices) (2008 – 2011)

Clinical Project Lead

Participated in protocol writing, CRF designing, study related documents development, report writing for IND, NDA submission, and final report

Managed study specific vendors

Professional Experience continued

Managed the conduct of assigned clinical investigations and activities associated with clinical trials

Managed the interaction of appropriate departments and staff to support and maintain the clinical investigations in drug safety

Assisted with preparation of department budgets, timelines, and project plans for drug safety

Negotiated contracts and budget for drug safety

Worked in the DMC board, actively participating in AE, SAE, initial reporting, follow-up, narrative writing, and resolution

Worked with the Medical Monitor for the patient safety review

Educational Background

MD, Medical Surgery – Rangpur Medical College, Rangpur, Bangladesh

Higher Secondary School Certificate – Mymensingh Girls’ Cadet College, Mymensingh, Bangladesh

Licensure and Certifications

Fundamentals of Project Management – Barnett International

Therapeutic Experience

Cardiology

Dermatology

Device

Endocrinology/Metabolism

oDiabetes

oMigraines

Oncology

oBreast

oGastrointestinal (GI)/ Genitourinary (GU)

Ophthalmology

Other Clinical Trial Experience

Phase I and II trials evaluating Breast Cancer, Solid Tumor, and other Cancers

Phase II and III trials evaluating Gastric Cancer and Renal Cancer

Phase I, II, and II trials evaluating migraines and devices

Phase II and III trials evaluating Diabetes Mellitus/Endocrine

Phase II and III trials evaluating Ophthalmology

Phase II and III trials evaluating skin disease

Phase II and III trials evaluating cardiovascular disease.

Covid vaccine

Kidney Transplant

General Anxiety

Languages

English, Bengali

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