Clinical Operations Manager

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

📋 Description

• Oversee daily monitoring tasks for assigned studies to ensure that all deliverables are achieved.

• Track and uphold project metrics and the status of deliverables.

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

• Address study inquiries and offer guidance as experts on Allergan standard study processes.

• Examine Site Feasibility Questionnaires and Site Qualification Visit reports.

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

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

• Provide training on PSMP and support GSMO orientation sessions.

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

• Participate in team meetings and communicate relevant information.

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

• Act as a Risk Based Monitoring ambassador to ensure the implementation and adherence to RBM practices.

• Manage the monitoring section of the study portal.

• Stay informed on ICH/GCP, regulatory requirements, Allergan SOPs, and therapeutic-area protocols and amendments.

• Monitor or co-monitor assigned trial sites.

• Mentor new LSMs and assist with their orientation training.

• Contribute to the development, improvement, and documentation of processes to ensure consistency.

• Train RSMs on trial specifics.

⛳️ Requirements

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

• At least 5 years of monitoring experience in a pharmaceutical or medical device company or clinical research organization.

• Over 5 years of experience in the industry.

• Preferred candidates 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 abilities.

• Skills in planning, organizing, metrics tracking, controlling, directing, and fostering innovation.

• Capable in decision making, judgment, and problem-solving.

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

• Demonstrates initiative and accountability.

• Experience in assigning, reviewing, and planning work for others.

• Competent in maintaining and coordinating activities.

• Ability to train RSMs on trial specifics.

🏝️ Benefits

• Equal opportunity employer.

• Committed to operating with integrity, driving innovation, transforming lives, and serving the community.