Site Activation & Contracts Specialist

This is a fully remote position, open to applicants in Saudi Arabia.

📋 Description

• Oversee designated sites throughout the comprehensive site activation process, from site selection and award to activation readiness.

• Facilitate the collection, review, and completion of necessary site start-up and essential documents.

• Assist in the preparation, submission, and follow-up of Ethics Committee/IRB and regulatory documentation.

• Monitor site activation milestones, pinpoint delays, and follow up with sites and stakeholders.

• Ensure that start-up documentation is thorough, precise, and filed/uploaded to relevant systems and the eTMF.

• Support eTMF quality control and resolve issues as they arise.

• Draft, execute, and process clinical trial agreements, investigator agreements, and related contractual documents.

• Negotiate investigator grant budgets and contractual terms within approved limits.

• Coordinate stakeholder review and escalate proposed contractual changes as needed.

• Follow up on unresolved contractual and budget matters.

• Track the progress of contracts, associated risks, and escalations.

• Provide insights on negotiation parameters and site/country contracting strategies.

• Collaborate with stakeholders to mitigate regulatory, legal, and financial risks.

• Maintain professional relationships with sites, Principal Investigators, and site personnel.

• Act as the operational contact during the activation phase.

• Work in collaboration with Study Start-Up, Site Contracts, Clinical Operations, Regulatory, Legal, Finance, and other departments.

• Identify barriers to activation and coordinate their resolution.

• Provide updates on milestones, risks, dependencies, and outstanding actions.

• Manage multiple sites and priorities in a matrix environment.

⛳️ Requirements

• Bachelor's degree or a combination of education, training, and relevant experience equivalent to this level.

• At least 2 years of clinical research experience that aligns with the role.

• Previous experience in supporting clinical trial site activation and/or site contract and budget negotiation is highly preferred.

• Experience with clinical trial sites in the Middle East is preferred.

• Knowledge of regulatory, Ethics Committee, and contracting requirements specific to one or more Middle East countries is highly desirable.

• Proficient oral and written communication skills.

• Strong interpersonal and stakeholder management abilities.

• Exceptional attention to detail and documentation quality.

• Effective negotiation and problem-solving skills.

• Well-developed organizational, planning, and prioritization capabilities.

• Ability to manage multiple site activation activities and deadlines simultaneously.

• Capacity to work independently and within cross-functional and matrix teams.

• Proficient computer skills and capability to quickly learn relevant clinical trial systems and software.

• Strong command of the English language and grammar; Arabic language skills are a plus.

• Basic understanding of clinical research, medical terminology, and clinical trial procedures.

• Familiarity with applicable GCP guidelines, regional/national regulatory requirements, Ethics Committee standards, and clinical trial contracting principles.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Supportive work environment with a focus on work-life balance.