Manager, Clinical Operations

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

📋 Description

• Supervise, train, allocate resources, coach, and manage the performance of a clinical operations team.

• Drive performance through end results, metrics, and key performance indicators.

• Address performance issues and training needs to ensure compliance with company SOPs and WPDs.

• Collaborate with leadership on resource requirements.

• Manage personnel while providing coaching, mentorship, and work direction.

• Conduct performance evaluations and career discussions; support employee career growth.

• Interview, recruit, and select new team members.

• Oversee the induction and orientation programs for new hires.

• Maintain updated staff CVs, training records, position descriptions, and experience profiles.

• Ensure timely and accurate submission of timesheets and expense reports.

• Assist in allocation activities and project/functional leads to enhance project operations.

• Raise concerns that could impact project deliverables.

• Provide training on WPDs, SOPs, local compliance, and clinical operations topics.

• Identify training deficiencies and ensure that training needs are fulfilled.

• Ensure compliance with ethical and regulatory standards.

• Notify management of quality issues and request or facilitate QA audits.

• Review systems such as Activate, CTMS, Preclarus, and Clarity to assess employee and project metrics, KPIs, and project status.

• Assess staff performance, including remote or on-site PAVs.

• Engage in process improvement and development initiatives.

• Ensure comprehension and facilitation of risk-based monitoring.

• Contribute to bids and the procurement of new business as needed.

• Work alongside senior management and executive staff on strategic planning and business development.

• Lead or participate in initiatives to enhance department and company performance.

⛳️ Requirements

• Prior experience of at least 5 years in a comparable role.

• Minimum of 1 year in a leadership position.

• An equivalent combination of relevant education, training, and/or directly related experience may be accepted.

• Advanced skills in mentoring, leadership, and supervision.

• Exceptional clinical trials monitoring abilities, both remotely and on-site.

• Understanding of or capability to learn company SOPs, WPDs, and applicable regulations, including ICH/GCP and FDA guidelines.

• Proficient in evaluating medical research data.

• Strong organizational and negotiation capabilities.

• Keen attention to detail.

• Excellent written and verbal communication skills.

• Good command of the English language and grammar.

• Proficiency in computer skills, including data entry, archiving, and retrieval.

• Willingness to travel as necessary.

• Team-building abilities.

• Strong interpersonal and conflict resolution skills.

• Effective problem-solving skills in a dynamic environment.

• Knowledge of medical/therapeutic areas and medical terminology.

🏝️ Benefits

• Reasonable accommodations for individuals with disabilities to participate in the job application or interview process.

• Additional benefits and privileges associated with employment.