Clinical Operation Manager

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

📋 Description

• Oversee daily monitoring tasks for designated studies and track project metrics and deliverables.

• Communicate and escalate issues, risks, and staffing requirements to the Program Lead, RSMs, and Clinical Trial Team.

• Offer study guidance and act as an Allergan standard study process expert for RSMs.

• Review Site Feasibility Questionnaires along with Site Qualification Visit reports.

• Maintain tracking reports for SIV, IMV, RMV, and COV activities.

• Create monitoring documents and trial toolkits, which include Protocol Specific Monitoring Plans, amendments, report annotations, and visit checklists.

• Provide training on PSMP and assist in GSMO orientation sessions.

• Conduct teleconferences with RSMs to deliver training and relevant information.

• Participate in team meetings and disseminate information effectively.

• Collaborate on study-specific eCRFs, completion guidelines, protocol deviation specifications, and user acceptance testing.

• Act as a Risk Based Monitoring ambassador and ensure adherence to RBM protocols.

• Maintain the monitoring section of the study portal.

• Stay updated on 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 enhancement.

⛳️ Requirements

• Degree in Allied Health Professions (PA, RN, RPh), relevant clinical experience, or a four-year life science degree.

• A minimum of 5 years' monitoring experience in a pharmaceutical or medical device company or clinical research organization.

• Over 5 years of industry experience.

• Preference for candidates who have served as a lead monitor or possess equivalent experience.

• Proficient in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, and Microsoft OneNote.

• Exceptional written and verbal communication skills.

• Strong planning, organizing, metrics tracking, controlling, directing, and promoting innovation skills.

• Capable of decision making, exercising judgment, and problem-solving.

• Strong interpersonal skills, influencing others, motivating employees, team building, and fostering development.

• Demonstrated initiative and accountability.

• Skills in assigning, reviewing, and planning work activities.

• Ability to maintain and coordinate multiple activities.

• Experience in training RSMs on trial specifics.

• Knowledge of ICH/GCP, regulatory requirements, Allergan SOPs, and relevant therapeutic-area protocols.

• Must be eligible to work in China; the job location is Beijing, China.

🏝️ Benefits

• Employees have the option to work remotely.

• Equal opportunity employer.

• Commitment to integrity, driving innovation, transforming lives, and serving the community.