Clinical Operation Manager

🔥 1 minute ago

🇨🇳 China – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

Where this job comes from

Posted on AbbVie's careers page, not through a job board

First seen by Remote Rocketship 1 minute ago

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Logo of AbbVie

AbbVie

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• 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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