Autodesk is hiring a Start Up Lead

Biogen is hiring a Start Up Lead to serve as an expert in global clinical trial site start-up activities. You will be accountable for executing the site start-up strategy and planning, ensuring the timely activation of sites.

What You'll Do

• Manage the site start-up process by developing an activation readiness strategy to oversee site start-up delivery.
• Coordinate, develop, and present critical path planning, including IRB/EC & CA/MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements, and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning and align operational goals for timely delivery.
• Participate in client meetings to establish expectations for delivery, communication, risk mitigation, status reporting, and metrics.
• Partner with Functional Leaders and Site Start-up Specialists to proactively identify delivery risks and execute mitigations.
• Provide oversight to ensure the accuracy and completeness of agreed tracking and systems are maintained in real-time.
• Coordinate translations for documents required for submissions.
• Maintain communication with key functions like Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts on project status.
• Act as a Subject Matter Expert (SME) for collecting and maintaining site-level critical path data points for IMP Release.
• Directly support country or site-level start-up activities if needed.
• Support the development of country-specific start-up summaries and process flows.
• Support the development and facilitation of training sessions to expand Country Start-up knowledge.
• Mentor staff on local study start-up regulations, submissions, internal procedures, and SSDL.
• Interact with clients in proposal activities, including slide development and presentations.

What We're Looking For

• Bachelor's degree in life sciences or a related field, a Registered Nurse (RN) qualification, or an equivalent combination of education, training, and experience.
• 5 years or more in start-up, ideally with SU Lead or PM experience in a CRO or pharmaceutical/biotech industry.
• 2 years or more of experience in project milestone management, managing resources, budgets, and coordinating team activities.
• Demonstrated leadership experience in driving cross-functional activities.
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
• Fluency in English and the local language for non-English speaking countries where the position is based.
• Experience using milestone tracking tools/systems.

Work Mode

This role operates in a local-country mode and is open to candidates based in Australia, Singapore, South Korea, and Taiwan.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.