AbbVie Sr. Associate Clinical Operation Manager in Shanghai, China

Sr. Associate Clinical Operation Manager

China, Shanghai, Shanghai

2 additional locations

ChinaChina, Shanghai

Research & Development

Requisition #1806412

Responsibilities :

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Accountable for all activities of site related study execution of assigned studies / staff involving startup,

execution, and closeout.

Accountable for the ontime

and within budget study execution of assigned projects,

including but not limiting to country and site feasibility. Provide local regulatory and legal requirement expertise.

• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH

Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in

conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.

Monitor regulatory reforms and industry trends within country / region, and provide impact analysis of significant

changes affecting conduct of Clinical studies.

• Ensure audit and inspection readiness of assigned sites. Advise on preaudit

activities for GCP requirements.

Prepare and follow up site and system audits, CAPA preparation and implementation. Conduct trending, impact

analysis and implement actions within country/district.

• Working with the Country/District Head, may be responsible for resource management of entire country/district.

Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with

AbbVie's research goals, priorities, and specific study timelines. Proactively identify and communicate issues

impacting resource allocation and provides solutions.

• Working with the Country/District Head, may be responsible for budget planning & oversight of expenses across


• Responsible for the acquisition and retention, performance management, and growth and development of talent.

• May be responsible for being the country point of contact for CROs for an assigned study / studies.

Participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.

• If assigned; Serve as key point of contact in country/district for clinical study programs. Update Impact/Tesla with


information: Countrylevel

planning timelines, LSR assignments, etc.

Qualifications :

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.

• Site Monitoring Experience: Minimum 3 years plus at least 1 year of direct line management experience preferred.

• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart

decision making.

• Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and

adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team


• Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with

experience leading (within country or region) projects with competing deadlines; Experience across multiple

Therapeutic Areas and Study Phases.

• Demonstrates/Drives continuous improvement and simplicity in process and approach and enhances agility.