Site Activation & Contracts Specialist

🔥 2 hours ago

🇸🇦 Saudi Arabia – Remote

💵 ر.س.200k - ر.س.300k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Contracts Specialist

👻 Ghost score 0%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Manage assigned sites throughout the end-to-end site activation process, from site selection/award through activation readiness • Coordinate collection, review and completion of required site start-up and essential documentation • Support preparation, submission and follow-up of Ethics Committee/IRB and regulatory documentation • Track site activation milestones, identify delays and follow up with sites and stakeholders • Ensure start-up documentation is complete, accurate and filed/uploaded to appropriate systems and eTMF • Support eTMF quality control and issue resolution • Draft, execute and process clinical trial agreements, investigator agreements and related contractual documents • Negotiate investigator grant budgets and contractual terms within approved parameters • Coordinate stakeholder review and escalation of proposed contractual changes • Follow up on outstanding contractual and budget issues • Track contractual progress, risks and escalations • Provide input on negotiation parameters and country/site contracting strategies • Partner with stakeholders to reduce regulatory, legal and financial exposure • Maintain professional relationships with sites, Principal Investigators and site personnel • Serve as an operational contact during activation • Collaborate with Study Start-Up, Site Contracts, Clinical Operations, Regulatory, Legal, Finance and other functions • Identify activation barriers and coordinate resolution • Provide status updates on milestones, risks, dependencies and outstanding actions • Manage multiple sites and priorities in a matrix environment

🎯 Requirements

• Bachelor's degree or equivalent combination of education, training and relevant experience • Previous clinical research experience comparable to at least 2 years • 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 preferred • Knowledge of country-specific regulatory, Ethics Committee and contracting requirements within one or more Middle East countries highly desirable • 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 and 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

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