Clinical Operation Manager, SSU

This is a fully remote position, open to applicants in China.

📋 Description

• Assist CSM personnel with country and site feasibility, site selection, and activation tasks.

• Aid in the creation and implementation of proactive Country Approval and Site Activation Plans.

• Conduct critical path analyses to identify and eliminate obstacles while minimizing delays.

• Support the planning for country and site activation, including IRB/EC submissions, site document gathering, and site contracting.

• Gather and analyze benchmarking data from AbbVie and the industry across designated disease areas/indications.

• Collaborate with cross-functional teams regarding templates and systematic study start-up procedures.

• Monitor study start-up timelines and milestones, escalating any risks as necessary.

• Assist in the creation and execution of risk mitigation strategies.

• Participate in lessons-learned sessions and integrate improvements into processes.

• Provide insights on best practices for country and site activation.

• Support initiatives that meet global regulatory standards and clinical program timelines.

• Lead the development of HGRAC strategic and implementation plans for accelerated SSU and site activation.

• Oversee resources and deliverables for the assigned CSSU team.

• Work together with stakeholders on study-specific training and staff allocation.

• Manage assigned CSSUs either directly or functionally, including hiring, onboarding, training, task delegation, mentorship, performance oversight, and professional development.

• Identify training needs and standardize as well as facilitate training solutions.

• Create onboarding and best-practice training materials and curriculum.

⛳️ Requirements

• Bachelor’s or Master’s Degree in a health-related field (e.g., Medical, Scientific, Nursing, Pharmacy) preferred.

• Minimum of 2 years of experience in a managerial or project management role.

• Background as a CRA with knowledge of the clinical trial lifecycle.

• Familiarity with SSU activities.

• Understanding of HGRAC management.

• Results-oriented individual.

• Ability to comprehend the global environment from both operational and cultural perspectives.

• Experience in building effective working relationships across various functions and geographical locations.

• Strong analytical, strategic, and critical thinking capabilities.

• Excellent interpersonal skills with the ability to influence without direct authority.

• Capacity to communicate clearly and demonstrate flexibility and adaptability to changing requirements.

• Resourceful and creative.

• Proven success in executing projects in a dynamic environment while managing multiple priorities.

• Proficient in utilizing multiple technologies for communication purposes.

🏝️ Benefits

• Full-time employment.

• Equal opportunity employer.

• Employer commitment to operating with integrity, fostering innovation, transforming lives, and serving the community.