Thermo Fisher / PPD
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
FSP Site Activation & Contracts Specialist – Middle East
Join Us as a FSP Site Activation & Contracts Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
Role Summary
The Site Activation & Contracts Specialist is responsible for supporting and managing the end-to-end site activation process for assigned clinical study sites across the Middle East.
The role combines Study Start-Up (SSU) and Site Contracting responsibilities, coordinating regulatory and Ethics Committee/IRB activities, essential document collection, site contracts and investigator grant budget negotiations to support timely site activation.
The Specialist acts as a key point of contact for assigned sites and works closely with internal and external stakeholders to identify and resolve activation barriers, ensuring activities are completed in accordance with applicable regulations, client requirements, study timelines and established processes.
Summary of Essential Functions
Site Start-Up & Activation
• Manages assigned sites throughout the end-to-end site activation process, from site selection/award through activation readiness.
• Coordinates collection, review and completion of required site start-up and essential documentation.
• Supports preparation, submission and follow-up of applicable Ethics Committee/IRB and regulatory documentation, in accordance with country-specific requirements and agreed study processes.
• Maintains working knowledge of applicable regional and national regulatory requirements, Ethics Committee requirements and country-specific start-up processes across assigned Middle East markets.
• Tracks site activation milestones, identifies potential delays and proactively follows up with sites and relevant stakeholders to drive timely completion.
• Ensures required start-up documentation is complete, accurate and filed/uploaded to the appropriate systems and eTMF within required timelines.
• Supports eTMF quality control and issue resolution, as required.
Site Contracts & Budgets
• Drafts, executes and processes clinical trial agreements, investigator agreements and other related contractual documents with clinical study sites and Principal Investigators.
• Negotiates investigator grant budgets and contractual terms and conditions within approved client negotiation parameters and established processes.
• Coordinates stakeholder review and escalation of proposed changes falling outside approved negotiation parameters and supports development of recommendations to resolve negotiations.
• Initiates and coordinates follow-up with sites and internal stakeholders regarding outstanding contractual and budget issues.
• Tracks contractual progress and communicates status, risks and escalations to the appropriate study and contract management stakeholders.
• Tracks recurring negotiation points and provides input to support updates to negotiation parameters and country/site contracting strategies.
• Partners with relevant stakeholders to reduce and/or eliminate regulatory, legal and financial exposure.
Site & Stakeholder Management
• Develops and maintains effective professional relationships with assigned sites, Principal Investigators and relevant site personnel.
• Serves as a key operational contact for assigned sites during the activation phase, helping coordinate regulatory, Ethics Committee, contracting, budget and documentation activities.
• Collaborates cross-functionally with Study Start-Up, Site Contracts, Clinical Operations, Regulatory, Legal, Finance and other relevant functions to progress sites toward activation.
• Proactively identifies site-specific activation barriers and coordinates appropriate actions and escalations to facilitate resolution.
• Provides clear and timely status updates on assigned sites, including key milestones, risks, dependencies and outstanding actions.
• Works effectively in a matrix environment and manages multiple sites and priorities simultaneously.
Role requirements
Education and Experience
• Bachelor's degree or equivalent combination of education, training and relevant experience.
• Previous clinical research experience comparable to at least 2 years, preferably within Study Start-Up, Site Activation, Site Contracts or a related clinical operations function.
• Previous experience supporting clinical trial site activation and/or site contract and budget negotiation strongly preferred.
• Experience working with clinical trial sites in the Middle East is preferred.
• Knowledge of country-specific regulatory, Ethics Committee and contracting requirements within one or more Middle East countries is highly desirable.
Skills and Competencies
• Effective oral and written communication skills.
• Excellent interpersonal and stakeholder management skills.
• Strong attention to detail and quality of documentation.
• Good negotiation and problem-solving skills.
• Strong organizational, planning and prioritization skills.
• Ability to manage multiple site activation activities and deadlines concurrently.
• Ability to work independently as well as effectively within cross-functional and matrix teams.
• Good computer skills and ability to quickly learn relevant clinical trial systems and software.
• Strong English language and grammar skills; Arabic language skills are an advantage.
• Basic understanding of clinical research, medical terminology and clinical trial processes.
• Knowledge of applicable GCP, regional/national regulatory requirements, Ethics Committee requirements and clinical trial contracting principles.
Compensation
The estimated annualized pay range for this position in is ر.س.200,000.00–ر.س.300,000.00.