Clinical Operation Manager
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Job Description
Clinical Operations Manager overseeing immunology clinical trials at AbbVie, which develops innovative medicines. Managing monitoring, regulatory compliance, risk-based monitoring, and site oversight.
Responsibilities:
- Manage day-to-day monitoring activities for assigned studies and track project metrics and deliverables
- Communicate and escalate issues, risks, and staffing needs to the Program Lead, RSMs, and Clinical Trial Team
- Provide study guidance and serve as an Allergan standard study process expert for RSMs
- Review Site Feasibility Questionnaires and Site Qualification Visit reports
- Maintain tracking reports for SIV, IMV, RMV, and COV activities
- Develop monitoring documents and trial toolkits, including Protocol Specific Monitoring Plans, amendments, report annotations, and visit checklists
- Provide PSMP training and assist with GSMO orientation sessions
- Conduct teleconferences with RSMs to deliver training and information
- Attend team meetings and disseminate information
- Collaborate on study-specific eCRFs, completion guidelines, protocol deviation specifications, and user acceptance testing
- Serve as Risk Based Monitoring ambassador and ensure RBM adherence
- Maintain the monitoring portion of the study portal
- Maintain knowledge of ICH/GCP, regulatory requirements, Allergan SOPs, and therapeutic-area protocols
- Conduct site monitoring or co-monitoring/oversight visits
- Mentor new LSMs, assist with LSM orientation training, and contribute to process development and improvement
Requirements:
- Allied Health Professions degree (PA, RN, RPh), relevant clinical experience, or four-year life science degree
- Minimum 5 years monitoring experience in a pharmaceutical or medical device company or clinical research organization
- More than 5 years of industry experience
- Prefer candidates who have functioned as a lead monitor or have equivalent experience
- Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, and Microsoft OneNote
- Excellent written and oral communication skills
- Planning, organizing, metrics tracking, controlling, directing, and promoting innovation
- Decision making, judgment, and problem solving
- People relationships, influencing others, motivating employees, team building, and developing people
- Initiative and accountability
- Assigning, reviewing, and planning work
- Maintaining and coordinating activities
- Training RSMs on trial specifics
- Knowledge of ICH/GCP, regulatory requirements, Allergan SOPs, and relevant therapeutic-area protocols
- Must be able to work in China; job location is Beijing, China
Benefits:
- Employees can work remotely
- Equal opportunity employer
- Commitment to operating with integrity, driving innovation, transforming lives and serving the community
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