Site Activation Manager

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $86k - $170k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Serve as the primary point of communication and accountability for study start-up and maintenance activities on assigned projects • Oversee functional groups involved in site activation to ensure critical path activities are completed on time and within budget • Compile, manage, track, and analyze site activation activities • Support feasibility and site identification activities as needed • Expedite the Site Qualification and Selection process • Communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM, and project team • Prepare risk assessment and mitigation plans for project deliverables • Ensure relevant study activities are included in the work order budget • Track out-of-scope activities and follow through on change orders • Develop and maintain site activation-related project plans • Contribute to SOPs, best-practice guidelines, training, and coaching • Provide input to departmental process improvement initiatives • Establish and interpret site activation metrics to drive corrective action • Contribute to proposals, budgets, and bid defense meetings • Report or escalate issues to appropriate Site Activation leadership • Comply with SOPs, ICH GCP, and applicable regulations • Liaise with functional contributors and vendors • Perform other duties as assigned

🎯 Requirements

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science OR two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and experience within clinical research (e.g. CRA, Reg Affairs) • Minimum of 4 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience • Proficient in cross-cultural communication • Proficient in both spoken and written English • Understanding of regulatory processes and guidelines • Understanding of initiation, planning, and execution of clinical projects and overall project planning • Awareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations • Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude • Strong leadership and organizational management skills • Ability to exercise sound judgment, make decisions independently, and proactively identify and solve problems • Ability to motivate, lead and engage a team • Strong interpersonal, oral, and written communication skills • Demonstrated ability to collaborate across the business • Ability to handle multiple tasks in a fast-paced and constantly changing environment • Ability to work in an organized, methodical, and self-motivated manner

🏖️ Benefits

• Competitive benefits package depending on location • Transparent compensation and pay equity