Clinical Operation Manager, SSU

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

📋 Description

• Assist CSM personnel with evaluating country and site feasibility, selecting sites, and facilitating site activation.

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

• Conduct critical path analyses to pinpoint and eliminate barriers and reduce delays.

• Assist in planning country and site activation, which includes IRB/EC submissions, gathering site documents, and site contracting.

• Collect and assess AbbVie and industry benchmarking data to support strategic start-up initiatives.

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

• Monitor study start-up timelines and milestones while escalating any risks encountered.

• Support the formulation and implementation of risk mitigation strategies.

• Participate in lessons-learned sessions and disseminate best practices across different functional areas and therapeutic domains.

• Assist in country approval and site activation efforts that align with global regulatory standards and clinical program schedules.

• Lead HGRAC strategic initiatives and implementation plans for expedited SSU and site activation.

• Oversee resources, deliverables, staffing, assignments, training, mentorship, performance, and growth for the designated CSSU team.

• Work collaboratively with stakeholders on training specific to studies and staff assignments to studies and sites.

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

• Create onboarding and best-practice training materials while staying informed about upcoming changes.

⛳️ Requirements

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

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

• Background in CRA and knowledge of the clinical trial life cycle.

• Familiarity with SSU activities.

• Understanding of HGRAC management.

• Results-oriented personality.

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

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

• Strong analytical, strategic, and critical thinking abilities.

• Excellent interpersonal skills; capacity to influence without authority and communicate effectively.

• Flexibility, adaptability, resourcefulness, and creativity.

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

• Proficiency in utilizing various technologies for communication purposes.

🏝️ Benefits

• Equal opportunity employer.

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