Site Activation Manager

🔥 2 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

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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 group project 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 & 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 present in the work order budget • Track out-of-scope activities in Change Notification Forms and follow through to change order execution • 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 and achieve deliverables, milestones, and KPIs • Contribute to proposals and bid defense meetings with Site Activation sections, budgets, and country/study-specific activities • Report or escalate issues to Site Activation leadership • Comply with SOPs, ICH GCP, and applicable national 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 • Strong leadership and organizational management skills • Ability to exercise sound judgment and make decisions independently • Ability to proactively identify and solve problems • Ability to motivate, lead and engage a team • Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment • Strong oral and written communication skills • Demonstrated ability to collaborate across the business • 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 FDA/EU Clinical Trials Directives/National regulations • Ability to handle multiple tasks in a fast-paced and constantly changing environment • Ability to work in an organized, methodical, and self-motivated manner • Proficiency in Microsoft Word, Excel, PowerPoint, and digital systems • Promotion to the next level is not automatic based on years of experience; personnel are evaluated on proven competency, level of responsibility, and ability to work independently

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible leadership • Equal employment opportunities • Training/coaching opportunities pertaining to Site Activation department