Site Activation Manager (Evergreen)

About the role

IQVIA is looking for a Site Activation Manager (evergreen) in Taipei to directly manage the delivery of site activation, maintenance and regulatory activities for selected studies or multi-protocol programs. The role covers pre-award activities, oversight of the scope of work, budget and resources, and works closely with regulatory teams and regions.

Key responsibilities

• Oversee site activation (including pre-award and bid defense) and/or maintenance in line with the agreed RSU site activation strategy and project timelines
• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, resolving project issues as needed
• Ensure collaboration between Regulatory and Site Activation, including communication with regions and countries, to deliver the agreed scope under the RSU Management Plan
• Create and review technical and administrative documentation to support business development, study initiation and maintenance
• Provide regulatory and technical scientific support for clinical trials while ensuring compliance with regulatory requirements
• Guide multi-regional and multi-protocol programs during start-up and maintenance as part of the study management team
• Determine regulatory strategy and parameters for submissions and authorizations, assess regulatory complexity and build regulatory intelligence
• Negotiate contracts and documents, work with Quality Management on quality standards, and mentor colleagues
• Maintain CTMS, databases, tracking tools, timelines and project plans accurately, and may lead relationships with preferred IQVIA customers
• Deliver presentations and training to clients, colleagues and professional bodies, and may take part in monthly study budget planning

Required profile

• Bachelor's degree in life sciences or a related field, or equivalent combination of education, training and experience
• 7 years' relevant experience in a scientific or clinical environment, including an international role
• Strong negotiation and communication skills, with the ability to challenge
• Excellent interpersonal skills and proven ability to work through others to meet quality and timeline targets on complex projects
• Proven ability to work on multiple projects and balance competing priorities

Required skills

• Thorough understanding of the regulated clinical trial environment and in-depth knowledge of the drug development process
• Proficiency with systems and technology, including CTMS
• Good regulatory and/or technical writing skills
• Strong knowledge of GCP and ICH guidelines and applicable regulatory guidelines
• Excellent understanding of study financial management
• Leadership, coaching and mentoring abilities, good presentation and organizational skills