Clinical Research Project Management

Ghassan Ahmed

Cell. +1-919-***-****

Email address: **********@*****.***

**** ********** ****, *******, ** 27370

Biography

Ghassan Ahmed brings over 20 years of research experience. During this time, Ghassan accumulated diverse expertise from working and collaborating with academic research organizations, pharmaceutical and biotechnology industries, and clinical research organizations. His specific research experience includes 5 years in managing epidemiological studies, 3 years in basic science and 14+ in clinical trials. This wide range of clinical research exposure, coupled with a medical background, has enabled Ghassan to quickly advance his clinical research career from a field CRA to a site manager, clinical trial manager and currently associate project director. During the past 14 years he has successfully managed phase I-IV hematology/ oncology domestic & global studies, enabling the opportunity to co-author several protocol amendments and all necessary protocol appendices.

In addition to his project management skills and experience, Ghassan has provided medical expertise for several Oncology/ Hematology and Gastroenterology studies, including providing medical support to participating studies, CMO to review CSRs, publications / presentations and developing new protocol concepts. While serving as a Lead CRA/ PM he gained sample management experience including Biomarker samples tracking and coordination between sites and central laboratories and/or central manufacturing facilities. Finally, in a recent role, Ghassan developed and maintained the Clinical Quality Management System including SOP, Work Instructions, and Process Maps. This role involved direct interaction with the Quality Control/Assurance Department and broadened Ghassan’s exposure to audits, quality compliance and training. These experiences have culminated in Ghassan being an integral part of the Biopharmaceutical Acceleration Model (BAM), which is shortening the distance from lab to life.

Specific oncology experience is noted below:

Phase

Indication

Countries

I/II

Multiple Solid Tumors

USA

I/ II

CAR-T Cells

USA, Europe & Saudi Arabia

I/ II

Gastro-esophageal Cancer

APAC region & USA

III

Osteosarcoma

USA

III

Small Cell Lung cancer

Global Study/ Middle East

II

Chronic Myeloid Leukemia

Saudi Arabia

II

Sickle Cell Anemia

Global Study/ Middle East

III

Anti-emetic for cancer patients

USA

Professional Experience

June 23 – 30 Nov 2023

Clinical Operation Director

Vergent Bioscience Inc.,

Provide ongoing support to study sites re: study conduct in the operating room and their study-specific issues.

Visit study sites during the trial to assess protocol compliance, specifically in the OR but in other areas as requested by the team.

Attend Study Initiation Visits as needed to meet and establish relationships with study-assigned Operating Room personnel.

Provide input to eCRF, CCGs, and protocol as needed.

Provide monitoring as needed during the study.

Back up to Lead Monitor

May 2022 – May 2023

Associate Project Director

Syneos Health- (Home based-NC, USA)

Project Leadership and Delivery:

Manages a project as a Project Manager overseeing interdisciplinary clinical research studies and/or programs and ensures compliance with GCP, relevant SOPs, and regulatory requirements.

Acts as primary liaison and/or facilitator between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.

Leads project team to ensure quality, timelines, and budget management.

Implements resource strategies to achieve project goals.

Accountable for all project deliverables for assigned projects.

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

Identifies and implements performance improvement and operational efficiencies

Reporting and Communication:

Maintains and evaluates project progress by maintaining timelines, project plans, and other tracking/analysis tools.

Produces and distributes status, resourcing, and tracking reports as well as functional area plans to customers, appropriate team members and senior management.

Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports; ensures adequate documentation of each communication.

Attends and presents information at internal and external project meetings.

Business Development:

Develop strong relationships with current and prospective clients to generate new and/or add-on business for the future.

Supports the Business Development Department by providing information on the company's capabilities, patient populations, etc., and presents Company capabilities as well as project-management specific responsibilities at Customer proposal defense meetings.

Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities. Works with this team to develop budgets and scope of work for the final contract.

Project Administration:

Responsible for 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.

Accountable for the 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.

Therapeutic Mastery:

Demonstrates mastery of current business unit therapeutic environment and drug development trends and facilitates the development of knowledge for more junior staff.

Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training.

Management:

Serves as team leader and line manager and mentors other project management and monitoring staff.

Facilitates team building and communication.

Ability to successfully deliver through successful delegation and oversight of project and functional leads.

June 2021 - May 2022

Study Manager

Daiichi Sankyo- (Home based-NC, USA)

Maintaining study operational and CRO Oversight including the Study timelines and budget

Simultaneously provide PM services to two drug development programs

Collaborating with leads of all functional groups to establish integrated project plans for each study

Keeping project teams informed, focused, and motivated to achieve short-term and long-term goals

Created integrated project plans using various project management software.

Performed risk assessment/management, and resource planning/management to ensure timely and successful project completion.

Made data-driven decisions to achieve quality improvements and operational success.

Led ongoing review of data to ensure quality and consistency by liaising with data management to resolve data discrepancies and ensure all data management study goals were met.

Served as a member of the project team to contribute towards efficient management and execution of trials

Apr. 2019 – Apr. 2021

Project Management Director

Precision for Medicine- (Home based-NC)

Serves as primary point-of-contact liaison with client to provide outstanding customer service, including participation in proposal activities and client presentations

Oversees and manages all aspects of a clinical research trials including budget management, status updates and metrics reporting

Prepares and reviews of protocols and other documents (e.g. CRF design, operating manuals, project plans etc.)

Oversees all aspects of study site management to ensure high quality data

Establishes, updates, tracks, and maintains study specific trial management tools/systems, and status reports

Manages site start up procedures including the recruitment of potential investigators, preparation of EC/IRB submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings or delegating these tasks as appropriate

Negotiates study budgets and assists with the execution of investigator contracts

Communicates effectively with both site personnel and Precision executive management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues

Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision’s high quality and ethical image

Maintains study tracking, in accordance with the demands of the study

Performs data management activities, including in-house CRF review, query resolution, and assists data management personnel to resolve data discrepancies

Identifies Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process

Travels as necessary according to project needs

Liaises with data management to resolve data discrepancies and ensure all data study goals are met.

Assists with review of clinical study reports

Conducts feasibility work and provides input to the development of proposals

Initiates payment requests for investigators

Apr. 2018 – Apr. 2019

Global Project Manager

AZ/ MedImmune (Home based-NC, USA)

Lead cross-functional clinical trial teams for two studies running in North America & Asia-Pacific Region

Define and manage accountabilities for all clinical trial team members

Collaborate with AD/D, Clinical Operations to ensure proper resourcing for assigned trials

Contribute to the Clinical Study Protocol (CSP) and may contribute to the Protocol Concept Sheet(PCS)

Develop outsourcing specifications for vendor requests for proposal and scope of work agreements

Participate in and guide study team in vendor selection

Manage the vendor(s) throughout the life of assigned clinical trial(s)

Select investigational sites with input from Clinical Development and vendors

Review, refine, and approve Clinical Operations Plans including study monitoring and other plans

Oversee investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and Clinical Research Organization (CRO) Team members including Clinical Research Associates (CRAs)

Lead ongoing review of data to ensure quality and consistency

Plan and conduct investigator meetings and can support advisory board planning and conduct ad boards

Develop and manage study budget and may develop and manage program budgets

Oversee site agreement/budget negotiation process

Develop and manage study timelines (including recruitment) and may develop and manage program timelines

Oversee the submission of trial-related and essential documents to the Trial Master File

Provide input into non-project related activities and development of procedures as requested

Provide or facilitate training to clinical study teams on protocol specific topics

Participate as appropriate in internal and external audits

Create study promotional materials

Oct. 2016 – Jan. 2018

Clinical Operations Director

Bellicum Pharmaceuticals, Houston, TX

Responsible for the onboarding of the company gene therapy products through performing the following responsibilities:

oActed as the global project manager for all clinical trials running in North America, Europe & Middle East, ensuring FDA inspection readiness status is maintained.

oActing Program Manager responsible for day-to-day operations in Europe & the rest of the world, including, Biomarker samples tracking and samples coordination, reviewing the CRAs trip reports and acting as the main point of contact to the sites

oAssist in the review of regulatory reports to ensure that reports accurately reflect proper interpretation of the study findings

oAssist to ensure annual IND and IB updates are completed in an accurate and timely manner

oCoordinate with the CMC group the manufacture and shipment of each study drug dose.

Manage the development process for critical study documents, ensuring cross functional input as needed (e.g., protocol, amendments, IB, ICF, and CRFs).

Provides clinical operations input in the identification, evaluation, and selection of CROs and vendors (e.g., central labs, central IRB, IVRS, etc.).

Leading the entire clinical operations, taking care of CRA’s report submission. 9 CRA’s reported to me directly.

Manage the identification, evaluation, selection, training and maintenance of investigators/sites

Ongoing assessment, evaluation, and management of internal and external resources

Ensure study supply requirements are met

Ensure accurate and timely communication with clinical study sites, internal and external cross functional teams to ensure study objectives are being met within project budget and schedule.

Supervise clinical operations team to ensure all study activities are completed in accordance with applicable regulations and guidance, and Bellicum SOPs

Prepare study timelines and budgets and ensuring study execution is aligned with these targets

Oversee the preparation of procedures for the conduct and monitoring of clinical research such as Clinical Monitoring Plans, procedures for reporting of adverse events, CRF completion guidelines, Study Manual, etc.

Liaise with PVG and provide clinical operations support and guidance for the ongoing surveillance of the safety of patients in clinical trials by reviewing reported AEs and SAEs and assure proper reporting of the events to the IRBs/REBs by running a listings & reports of the Argus system.

Liaise with Data Management to review data discrepancies and ensure that data clarification forms (queries) are appropriately handled by the CRAs and responded to by the site/investigator in a timely manner. May assist in the review of queries to determine criticality of the DCF during data clean-up and lock process

Liaise with study site personnel and clinical investigators to provide study related guidance and answers to operational issues.

Manage subordinates and vendors, and monitor study related expenses to meet forecast

Provide guidance and comments on SOPs revisions. May act as a leader of a SOP sub-committee for SOP revisions

Perform Site Initiation Visits and visit sites with the assigned monitors as needed to provide hands-on training as well as to discuss study related issues and problems with the Principal Investigator and/or site staff

Member of the Medical Team respond to sites medical questions

Create study promotional materials

Mar 2015 - Oct 2016

Clinical Research Associate

NOVELLA CLINICAL, Morrisville, NC

Sr. Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators to evaluate the capability of the site to successfully manage and conduct the clinical study

Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested by Clinical Trial Manager

Works with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtains and reviews regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.

Performs study initiation activities, providing training on the protocol, regulatory issues, study procedures, eCRF; monitoring activities and study close-out activities

Conducts periodic site file audits to ensure compliance with GCPs and Novella standard operating procedures

Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through in-house and on-site monitoring visits conducted in accordance with GCP and monitoring plan.

Documents accountability, stability and storage conditions of Biomarkers samples as required by sponsor. Performs investigational product inventory, ensuring return of unused materials to designated location or verifies destruction as required

Serves as primary contact between Novella and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested

Create study promotional materials

Feb 2013 - Mar 2015

KING ABDULLAH INTERNATIONAL RESEARCH CENTER (KAIMRC), Riyadh, KSA

Clinical Trial Unit Manager- Contract- Saudi Arabia

Lead the development, management and implementation of clinical development deliverables/activities including but not limited to: development of study protocols and site budgets, CRF/e-CRF design, investigator/site project team training/investigator meetings, operational processes, vendor selection / management, clinical study reports, safety reporting, and accountability of study product supply

Ensured site and study compliance to study protocols and adherence to applicable regulations and IRB requirements

Managed budgets versus timelines and deliverables

Prepared internal files and investigative sites for Health Authority inspections/internal audits

Ensured Trial Master File content compliance with applicable work instructions, SOPs, and ICH/GCP guidelines for all assigned sites and studies

Acted as the point of interaction between KAIMRC as the sponsor and all CROs/ Third parties’ vendors

Publication planning and presentation preparations

Managed and oversaw all aspects of the Clinical Trial Unit contract and investigator-initiated research studies undertaken with industry, other research institutions or public health services in the biopharma sector

Managed Clinical Trial Coordinators

Reviewed monitors reports

Managed Clinical Trial Unit budget

Developed & managed relationships with internal and external research partners

Responsible for oversight the QA activities for all sponsored clinical trials at KAIMRC

Negotiated contracts specifications with the sponsor/ CRO

Create the unit promotional materials

Jun 2011 - Oct 2012

QUINTILES BIO-PHARMACEUTICALS, Vienna, Austria

Global Clinical Research Specialist- Middle East & E. Europe

Oversaw the studies conducted in Eastern Europe & Middle East and reported to the Project Manager in USA

Assisted in the design and implementation of the Monitoring Plan, leading a team of 12 CRAs and CTAs, responsible for their submission process, report presentations etc.

Assisted in the startup activities including regulatory authority submission

Performed different types of monitoring visits e.g., SSV, SIV, IMV &COV

Feasibility Studies

Prepared and reviewed consent forms, as required

Supported GTL (Global Trial Lead) in ensuring all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards

Manage the trial master file in the assigned territory

Supported Medical Lead by generating periodic data cleaning reports as assigned

Oct 2009 - Jun 2010

GENETICS & IVF, Fairfax, VA

Medical Reviewer

Initial review of subject’s medical charts and Medical History Forms to determine eligibility and help the principal Investigator to take the final eligibility decision

Follow up on AEs

Reviewed and provided assurance of medical content and clinical relevance of regulatory safety documents

Performed Quality Audit for each individual medical record to check for missing documentation

Dec 2006 - Sep 2009

CLINTEC INTERNATIONAL/ CLINART, Scotland, UK

Regional Project Manager – Europe & Middle East

Assisted in the design and implementation of the Monitoring Plan.

Assisted in the start-up activities including regulatory authority submission

Performed many Feasibilities Studies

Maintained effective communication with clients, sites, and internal teams through oral and written communication and status reporting

Assisted in budget and contract preparation and ensure project team awareness of scope

Anticipated major events/risks and impact on milestones and propose solutions

Coordinated/assisted in the design and development of Case Report Forms

Assisted with writing IB updates, annual reports and other regulatory documents

Recruited, approved and co-monitored investigator sites

Collaborated with Clinical Services to determine the frequency of on-site monitoring and ensure adequate and timely assignments of site monitors

Provided day-to-day management of assigned clinical trials. May be primary interface between sponsor and all vendors (CROs, global monitors, central labs, other vendors, and PIs/investigator sites)

Apr 2006 - Nov 2006

BEARDSWORTH, Flemington, NJ

In- House Site Manager- North America

Coordinated all aspects of assigned clinical activities in 26 Investigation Sites, including monitoring visits

Developed and maintained, in conjunction with Project Management, detailed project timelines for assigned clinical trials. Identify risks and develop contingency plans to reduce the impact of risks

Provided accurate and timely written and verbal communications concerning the assigned clinical trial(s), including management updates

Apr 2005 - Mar 2006

COVANCE, Princeton, NJ

Clinical Research Associate

Assist in the site selection process

Responsible for all aspects of study site monitoring including site initiation, routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits with accurate and timely trip reports; liaise with vendors

Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data

Assisted with recruitment of potential investigators, preparation of regulatory submissions, translation of study-related documentation, organization of meetings and other tasks as instructed

Completed Serious Adverse Event (SAE) reporting process, production of reports, narratives and follow up

Oct 2004 - Mar 2005

SEPRACOR INC., Marlborough, MA

Central Lab Manager

Meet protocol requirements and are in accordance with internally established timelines and ensure that it in comply with U.S., ICH/GCP and any pertinent local regulations

Adhered to Company SOPs, policies and guidance documents

Ensured the accuracy of documentation regarding clinical laboratory testing in CODA-supported clinical studies through cross-functional coordination

Maintained and reviewed all applicable SOPs, policies and guidance documents governing GLP and clinical lab testing

Reviewed CLS vendor SOPs as a clinical representative

Participated, where pertinent, in the generation of laboratory safety sections for CSR appendices and NDA submission documents

Managed contracts and work orders for CLS vendors

Jun 2004 - Sep 2004

UNITED NATION/ E&E CONSULTANT INC., Buffalo, NY

Clinical Research Consultant/ Medical Advisor – Contract- ME

This project was funded by the UN, and implemented by E&E Consultant following the Standers of the American National Institute of Health. The main aim of this project was to study the effect of the first gulf war on the Saudi citizens with focus on the oncology effect of the radioactive materials

Project Spokes Person in front of the media

Pharmacovigilance: Adverse Event Reporting according to the company’s SOPs

Medical Information: Responding to the medical queries from HCPs, Patients or Public

Medico-Marketing Activities: Includes Development of KOLs through Advisory Boards, Round Table Discussions, and Group Meetings. Building capable confident Field Force through continuous training, updates & regular assessments

Regulatory Activities: Registration of Products and following up on minor variations. Building strong relation with the Governmental Decision Makers. Translation, Review and electronic approval of Package Inserts

Assisted the Project Manager in the initiation, monitor and close out of the investigative sites

Assured regulatory compliance of investigational sites with company, FDA, ICH-GCP and SMH guidelines

Assured site compliance with the project reporting process

Assisted the Project Manager in the creation and review of protocols, informed consents, case report forms, monitoring tools, clinical study reports and other study-related materials

Maintained frequent contact with and work effectively with investigators and site coordinators

Jun 2002 - May 200 4

THOMAS JEFFERSON UNIVERSITY, Philadelphia, PA

Postdoctoral Fellow

The long-term goals of this research were to examine the role(s) of endothelium cells in innate immunity as it expressed in their response in exposure to bacterial toxins, such as Gram-negative endotoxin (lipopolysaccharide, LPS), and soluble and membrane-associated host proteins. The objectives of this project were

Develop two immortal cell lines derived from Brain and Intestinal micro-vascular endothelial cells

Determine the optimal transfection protocol for the MVEC

Determine the optimal growing media for the MVEC

Jun 2000 - May 2002

TEMPLE UNIVERSITY, Philadelphia, PA

Research Teaching Assistant-ship

Worked under Dr. J. Litvin to identify heart related developmental factors relative to commitment and differentiation factors and positive enhancers of cell proliferation within fetal hearts

Collected embryonic chicken and rat heart samples, prepared mini/maxi plasmid preps, performed in situ hybridization to examine the expression of known and novel genes and studied the effect of temporary knock out of some of the novel genes that had been introduced by the PI, using siRNA and other molecular techniques

Worked under Dr.'s Mary Barbe and Dr. Fayez Safadi to identify pathologic associated with repetitive task

Participated in behavioral training of rats performing high repetition, negligible force reaching and grasping tasks

Jun 1996 - Mar 2000

US AGENCY FOR INTERNATIONAL DEVELOPMENT (USAID), Cairo, Egypt

Out-Reach Medical Liaison

This project was aiming to decentralize the MOH hospitals in Egypt. We started with five hospitals as an example for the rest of the MOH hospitals. We had the American system as our guide to follow, by creating capitalized hospitals that are able to compete with the private sector and be able to generate their own revenue

Prepares and maintains section statistics and reports. Prepares periodic reports to the senior hospital management

Directs, coordinates, supervises and participates in the work of the hospital education/training committee to assess the training needs of the facility and the development, implementation, coordination/supervision, and documentation of the facility-training plan and all facility training activities

Ensures the documentation of all education / training activities and the submission of timely reports regarding completed training

Assist training unit in managing training activities conducted at the Governmental level for:

oRaedat-Refeat Project: This project aimed to promote reproductive health among the women in the rural areas in Egypt, through recruiting representatives that go from door to door and promote the positive practice of reproductive health

oMCH Nurses: This project aimed to promote good practice of infection control methods among the registered nurses in the Egyptian public hospitals

Mar 1992 - Mar 1996

HELWAN GENERAL HOSPITAL,

Egyptian MOHP, Cairo, Egypt

Resident

Under the supervision of the attending medical staff. I did assist with admissions, consultations, evaluations, diagnosis and treatments of a broad spectrum of undifferentiated patients, with an emphasis on quality of patient evaluation and care, maintaining accurate medical records, and including interactions with the family.

Therapeutic Experience

Hematology: AML, ALL,

Infectious Disease: Hepatitis B & Prostatitis

Oncology: Advanced Solid Malignancies

Rare Disease: Primary Immunodeficiency & Hemoglobinopathies

Languages

English: Speaking, Reading, Writing

Arabic: Speaking, Reading, Writing

Professional Certifications & Licensures

Project Management Professional Certificate: Apr-2012

License to practice medicine in Egypt: Mar-1992

Education

1984 - 1990

Cairo University - Egypt

Doctor of Medicine MD-Medicine & Surgery

Contact this candidate