Samer Salama
Clinical Contract Negotiator
Glendale,AZ
Summary
I have worked in the eld of Clinical Research for 6 years, two of which have been in Clinical Project Management. As a Project Manager I have worked in both the Academic and CRO settings. I have sucessfully managed multiple Global and National projects. I have a Bachelors Degree in Life Sciences and a Masters Degree in Clinical Research Management. I have exceptional leadership skills, project management skills, and thrive in high-pace work environments.
Overview
7
7
years of professional experience
Work History
Clinical Contract Specialist
University Of California Los Angeles (AMPCUS)
11.2023 - Current
- Ensure adherence of ICH-GCP guidelines, CFR guidelines, organization's SOPs and provide feedback on SOPs, procedures and practices for better development for future projects.
- Responsible for contract and budget negotiations of various agreements such as CTAs, CDAs, Master Services Agreement, Statement of Work and more. The contract negotiations involved full understanding of FDA, IRB and SOPs regulations of the establishment.
- Develop and maintain effective relationships with internal and external stakeholders to manage assigned staff in a matrix environment.
- Responsible for financial negotiation and management between Sponsor, CRO and Vendors during Study Start up and Maintenance phases.
- Review and support during the creation of the Protocol and Informed Consent documents.
- Support on regulatory submissions to the Local IRB
- Utilization of systems such as the CTMS, and TMF.
- Support in the negotiation the SOW budgets between the Sponsor, CRO and Vendors.
Clinical Project Manager
Cliantha Research
06.2022 - 07.2023
- Ensure adherence of ICH-GCP guidelines, CFR guidelines, organization's SOPs and provide feedback on SOPs, procedures and practices for better development for future projects.
- Responsible for contract and budget negotiations of various agreements such as CTAs, CDAs, Master Services Agreement, Statement of Work and more. The contract negotiations involved full understanding of FDA, IRB and SOPs regulations of the establishment.
- Responsible for all financial and legal negotiations with the sponsor, vendors, and selected sites.
- Create and implement Project Management Plan, Communication Plan, Clinical Monitoring Plan, Central Monitoring Plan, Data Management Plan, Risk Management and Mitigation Plan, Protocol Deviation Handling Plan, Medical Monitoring Plan, Vendor Management Plan, etc.
- Management and oversight of the development and use of systems such as the CTMS, TMF, project specific EDC systems, and project specific IWRS systems.
- Project Finance Tracking, and Invoice tracking for Vendors and sites.
- Effectively communicate and develop management strategies, risk mitigation strategies, policies and procedures in conjunction with leadership teams on assigned projects.
- Develop and maintain effective relationships with internal and external stakeholders to manage assigned staff in a matrix environment.
- Responsible for all Vendor Management activities.
- Develop and maintain good working relationships with internal and external clients to ensure upmost achievement on project deliverables, timelines and quality standards.
- Responsible for conducting Internal and External stakeholders meetings throughout the duration of the trial including weekly meeting updates, vendor management meetings, Internal and External Kick-off Meetings, and Investigator Meetings.
- Support on regulatory submissions for the USA, Canada and India.
- Coordination and supervise the study team for the study/site feasibility, and PI (Principal Investigator) database updates.
- Management and Coordination with the Sponsors to drive the project deliverables and timelines by utilizing tracker, Gantt charts, and other organizational tools.
- Review and support during the development of the Protocol and Informed Consent documents with all stakeholders.
- Responsible for monitoring the progress/performance of all projects to include quality of services provided timeliness of deliverables, compliance with regulatory requirements, and adherence to financial targets.
- Managed preparation and execution of internal and external audits.
- Support during Clinical Monitoring Visits with the CRAs.
- Line Management responsibilities to promote CRA, CTA and CTM professional development including the ongoing training, and continuing education.
- Management of resource allocation pertaining to ongoing projects.
- During my tenure, I lead successfully one global project, one national project and supported on a third project. I conducted studies in nephropathy, investigational device and oncology.
Clinical Research Specialist
Saint Joseph's Hospital and Medical Center
03.2021 - 06.2022
- Implement, execute, and manage all assigned Sponsor-Initiated and Investigator-Initiated Protocols in compliance with FDA, CFR, GCP and SOP guidelines.
- Responsible for contract and budget negotiations of various agreements such as CTAs, CDAs, Master Services Agreement, Statement of Work and more. The contract negotiations involved full understanding of FDA, IRB and SOPs regulations of the establishment.
- Regulatory responsibilities pertaining to IRB submissions, and the management of financial disclosures, Protocol Training logs, Delegation of Authority logs, 1572s, etc.
- Responsible for the development and training of new and existing staff members in various departments on clinical research and the workflow.
- Conducted Team meetings to discuss project updates and site level progress .
- Responsible for utilizing various CTMS and EMR, EDC and IWRS systems.
- Utilization and implementation of trackers, Gantt Charts, and other organizational tools to track the progress of all studies, timelines and deliverables.
- Track finances and budgets of all awarded clinical trials.
- At any given time I supervised 15 Clinical Trials in Phase I-IV varying in infectious disease, internal medicine, oncology and device trials.
- Responsible for applying for Sponsor-Initiated Clinical Trials, completing feasibility reports based off of the Site's patient population.
- Interface between Sponsor/CRO to obtain essential documents such as CDA, CTA, Budget, Informed Consent form, Protocol, Pharmacy Manual, Investigational Brochure, Material Transfer Agreement, Master Service Agreements, Statement of Work, Notice of Award, and the CMS agreement.
- Direct reporting between Program Manager and Investigators regarding Pre-Award process.
- Responsible for managing Clinical Research Coordinators to improve quality and efficiency.
- Responsible for managing budgets to ensure a specific profit margins.
- Responsible for grant proposal writing for new research institutions and Fellowship programs.
- Responsible for writing protocols for Investigator-Initiated Trials.
Clinical Research Coordinator
Synexus | PPD
03.2020 - 03.2021
- Implement, execute, and manage all assigned Sponsor-Initiated Clinical Trials in compliance with FDA, CFR, GCP and SOP guidelines.
- Responsible for completing 80 Screening/Randomization Visits and 54 Follow up visits in a quarter.
- Conducted all CRC related tasks associated with successfully executing a clinical trial.
- Regulatory responsibilities such as completion of Financial disclosures, Protocol training logs, Delegation logs, IRB Continual Review, and the FDA 1572.
- Responsible for training new staff members in various departments on clinical research and the workflow.
- Responsible for utilizing various CTMS and EMR, EDC and IWRS systems.
- I supervised 8 Clinical Trials in Phase II-IV varying in Vaccine, Cardiovascular, and Pain Management research trials. Responsible for completing feasibility reports based off of the Site's patient population.
- Communication between Sponsor and CRO to obtain essential documents.
- Responsible for the initial redlining of the CTA per FDA and IRB Regulations, and preliminary Budget negotiation of line items in reference to our PFA.
Clinical Research Coordinator
Arizona Arthritis and Rheumatology Research
05.2017 - 07.2019
- Implement, execute, and manage all assigned Sponsor-Initiated and Investigator-Initiated Protocols in compliance with FDA, CFR, GCP and SOP guidelines.
- Responsible for increasing subject enrollment on various clinical trials by 40% throughout time of employment.
- Conducted all CRC related tasks associated with successfully executing a clinical trial.
- Regulatory responsibilities such as completion of Financial disclosures, Protocol training logs, Delegation logs, IRB Continual Review, and the FDA 1572.
- Responsible for training new staff members in various departments on clinical research and the workflow.
- Conducted meetings with Physicians to new Clinical Trials and enrollment progress on current trials.
- Responsible for utilizing various CTMS and EMR, EDC and IWRS systems.
- At any given time I supervised 15 Clinical Trials in Phase II-IV varying in rheumatological indications, cardiovascular and device trials.
- Communication between Sponsor and CRO to ensure quality management of the clinical trial.
- Direct reporting between Program Manager and Investigators regarding enrollment progress in the trial.
- Responsible for upload Clinical Trials in the CTMS, creating invoices and managing sponsor payment.
Education
Masters of Science Degree - Clinical Research Management
Arizona State University
Glendale, AZ 10 2021 - 12 2023
Bachelors of Science Degree - Life Sciences
Arizona State University
Glendale, AZ 08.2010 - 5 2014
Certification - Healthcare Project Management
American University
Washington, DC 01.2022 - 3 2022
Skills
Project Management
Leadership Skills
Contract Negotiations
Legal Negotiations
Risk Management and Mitigation
Resource Allocation
Project Bid
Time Management
Communication
Smartsheet Experience
Project Management Tools Experience
Microsoft Office Experience
Timeline
Clinical Contract Specialist
University Of California Los Angeles (AMPCUS)
11.2023 - Current
Clinical Project Manager
Cliantha Research
06.2022 - 07.2023
Certification - Healthcare Project Management
American University
01.2022 - 3 2022
Clinical Research Specialist
Saint Joseph's Hospital and Medical Center
03.2021 - 06.2022
Clinical Research Coordinator
Synexus | PPD
03.2020 - 03.2021
Clinical Research Coordinator
Arizona Arthritis and Rheumatology Research
05.2017 - 07.2019
Bachelors of Science Degree - Life Sciences
Arizona State University
08.2010 - 5 2014
Masters of Science Degree - Clinical Research Management
Arizona State University
10 2021 - 12 2023