Site Activation Partner III - FSP
Primary Location: Saudi Arabia, Remote Job ID R0000038027 Category Clinical Trials Date Posted 01/15/2026Overview
As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.
Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Flexible
- Organized
- Problem-solver
- Self-starter
About This Role
The Site Activation Partner III (SAP III) is responsible for leading operational activities from start up to close out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards. SAP III is accountable for working with local business lines to lead the operational submissions to Central and/or Local Ethics as well as submissions to other governing bodies in the country (ies) within scope. Responsibility span within a country or multi-country depending on the geographical region and business needs.
Key Accountabilities:
Main Duties-Central and/or Local Ethics interactions
Drive Ethics Committee (EC) submission management activities for respective studies and sites
Partners with local country stakeholders (Site operations, Regulatory) and/or preferred CROs (pCROs), with responsibility and management of required activities, and deliverables associated with Central and Local Ethics submissions
Partners with hub stakeholders (e.g. CTA hub; contract specialists) for deliverable associated with Central and/or Local EC submissions
Contribute to providing timelines and deliverables, to meet study and country timelines for site activation as it relates to ethics submission deliverables
Provide status updates on submissions, queries and feedback
Liaise with local and regional stakeholders, study teams, and pCROs for essential documents required for the submissions
Responsible for high quality and compliant submissions
Prepare the EC package and other associated documents according to the local requirements in collaboration with team members
Review and cross check submission packages to ensure they meet the EC requirements
Submits EC packages (Central and/or Local) and other bodies where applicable according to agreed timelines
Coordinate the timely communication, documentation and responses between client and Central/Local Ethics committee to bring clinical study to approval (country dependent)
Manage activities with Investigators sites and required documents, and perform site level ethics submissions and progress to approval
Manage governing bodies submissions, as applicable, in countries where required (e.g. Australia)
Manage and ensure continuation of Institutional Review Board(IRB) / Ethic’s and other committees activities post site initiation visits, and related submission, notifications, reapprovals, etc.
Ensure timely filing of documents to electronic Trial Master File (eTMF)
Actively participate in continuous quality improvement activities and applies quality improvement principles to all duties performed
Clinical Trial Site Activation
Initiate and coordinate activities and essential documents management towards the compilation of a high quality Investigator Initiation Package (IIP) leading to approval for sites initiation
Provide support to resolve issues or concerns and timely escalation of site issues where applicable
Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
Support and implement activities in Shared Investigator Platform to align with client strategy as it relates to the role
Clinical Trials Conduct
Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, ethics committee annual approvals and other activities required during study conduct
Ensure maintenance of IRB/Ethics and other committees’ activities as applicable
Responsible for timely filing of documents to Trial Master File (TMF) and assisting with periodic quality review of study files for accuracy and completeness
Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections
Communication
Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
Provide functional updates on a country and site level as required
Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals
Disseminate central or local ethics approval to study team and Investigator sites where applicable
Communicate local sites approvals to study team members and stakeholders
Subject Matter Expert (SME)
A deep understanding of the site activation requirements and processes within the country/region and be able to develop and implement in more than one country to enable multi-country coverage
May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multiple countries
Represent the SAP role on the study
Take the lead in the compilation and preparation of the Investigator Initiation Package (IIP) Template for the study and share with SAP team globally
Communicate with SAPs globally on study information and timelines
Act as SME on one or more system and/or process, be the go-to person and train the SAPs on these respective systems or processes
Represent the SAP role on reginal and global initiatives
Able to act as an SME on projects and initiatives, as requested
Mentor for new hires on processes, systems and SAP activities facilitating and optimizing the time from hire/training to assignment on a study
Able to manage a high volume of complex studies at sites
Skills:
Knowledge of clinical research and development processes, key operational elements of a clinical trial, and ability to gain command of process details
Understand the quality expectations and emphasis on right first time
Compliance with all applicable company, regulatory and country requirements
Attention to detail evident in a disciplined approach
Ability to work independently and also as a team member
Ability to organize tasks, time and priorities, ability to multi-task
Understand basic medical terminology, GCP requirements and proficient in computer operations
Ability to use and learn systems, and to use independently
Microsoft Suite
Clinical Trial Management Systems (CTMS)
Electronic Trial Master File
Electronic Investigator Site File (e.g. Florence)
Document exchange portals
Shared Investigator Platform
Ethics, National Networks and Governing Bodies Portals and platforms
Flexible and adapt to off working hours in a global environment (when applicable)
Able to travel as needed, including some international travel possible
Knowledge and Experience:
Background in site monitoring strongly preferred – experience with/understanding of pre-trial assessment (PTA) visits and site initiation visits (SIV)
Significant experience with study startup/initiation within industry, including assembly of investigator initiation packages (IIP)
Well-versed in Saudi ethics and regulatory environment; Confident in working directly with Saudi Ethics/Regulatory Committees
Flexible to travel to sites to support assembly of Ethics submissions, PTAs and/or SIVs, or to deliver submissions to Ethics Committee (<20% travel anticipated)
Familiarity with site budgeting/contracting processes
Fluency in Arabic and English required
Experience working in the pharmaceutical industry/or CRO in a similar role
Experience of interacting with regulatory agency or Ethics Committee required
Deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations and requirements
Good technical skills and ability to learn and use multiple systems
Experience working in a global environment, working in more than one country preferred
Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
Education:
High School Diploma/GED (or Country equivalent) with at least 10 years relevant experience in Clinical Trials, Regulatory, and ethics environment; Bachelors degree preferred
Bachelor of Science, Bachelor of Arts, Masters of Science or equivalent with minimum of 6 years combination of education, training, experience is preferred
Education in sciences or healthcare discipline is preferred
#LI-REMOTE
Potential Career Path
Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.
- APEX CRA
- CRA I
- CRA II
- Senior CRA
- Project ManagementSubject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
Why Clinical Research Associates work at Parexel
