Site Activation Manager

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

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 group activities 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 and Regulatory project status to the Sponsor, GPL/CPM, and project team • Prepare risk assessments and mitigation plans for project deliverables • Ensure relevant study activities are included in work order budgets • Track out-of-scope activities in Change Notification Forms and follow through to change-order execution • Develop and maintain site activation 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 for deliverables, milestones, and KPIs • Participate in business development activities, proposals, and bid defense meetings • Report or escalate issues to Site Activation leadership to minimize delivery risks • Comply with SOPs, ICH GCP, and applicable national regulations • Liaise with functional contributors and vendors • Perform other assigned duties

🎯 Requirements

• Four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or another related science, OR two-year college curriculum or equivalent education/training with clinical research experience • Minimum 4 years of CRO/pharmaceutical industry experience, preferably in start-up management, project management, and/or site management • Proficient in cross-cultural communication • Proficient in spoken and written English • Understanding of regulatory processes and guidelines • Understanding of clinical project initiation, planning, execution, and overall project planning • Awareness of ICH GCP Guidelines and FDA/EU Clinical Trials Directives/National regulations • Ability to manage multiple tasks in a fast-paced, changing environment • Strong leadership and organizational management skills • Sound judgment and independent decision-making • Problem-solving ability • Ability to motivate, lead, and engage a team • Strong interpersonal, oral, and written communication skills • Demonstrated cross-business collaboration • Organized, methodical, and self-motivated work style • Proficiency in Microsoft Word, Excel, PowerPoint, and digital systems

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible leadership • Equal employment opportunities • Exceptional employee experiences

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