Clinical Operation Manager, SSU

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

📋 Description

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

• Aid in the development and execution of Country Approval and Site Activation Plans.

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

• Support planning for country and site activation, which includes IRB/EC submissions, collection of site documents, and site contracting.

• Gather and evaluate AbbVie and industry benchmarking information.

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

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

• Assist in the creation and implementation of mitigation strategies.

• Participate in lessons-learned sessions and disseminate best practices.

• Offer expertise regarding best practices in country and site activation.

• Formulate and execute country approval and site activation initiatives that align with global regulatory standards and clinical program timelines.

• Lead the formulation of HGRAC strategic and implementation plans aimed at accelerating SSU and site activation.

• Oversee resources and deliverables for the designated CSSU team.

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

• Manage assigned CSSUs, which includes hiring, onboarding, training, task delegation, mentorship, performance management, and professional development.

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

⛳️ Requirements

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

• Minimum of 2 years of experience as a people manager or project manager.

• Background as a Clinical Research Associate (CRA) and understanding of the clinical trial lifecycle.

• Familiarity with SSU activities.

• Knowledge of HGRAC management.

• Results-oriented mindset.

• Ability to comprehend the global landscape from both operational and cultural viewpoints.

• Experience in building effective working relationships across various functions and geographic areas.

• Strong analytical, strategic, and critical thinking capabilities.

• Excellent interpersonal skills; adept at influencing without direct authority and communicating effectively.

• Flexibility, adaptability, resourcefulness, and creativity.

• Proven ability to successfully execute projects in a fast-paced environment while juggling multiple priorities.

• Competence in using various technologies for communication purposes.

🏝️ Benefits

• Equal opportunity employer.

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