FSP Manager – Clinical Operations

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

📋 Description

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

• Drive performance through the use of metrics and key performance indicators.

• Serve as the escalation point for performance issues and training requirements.

• Work in partnership with leadership to address resourcing needs.

• Guide staff through coaching, mentorship, and direction in their work.

• Conduct performance evaluations and career discussions; facilitate career growth.

• Participate in interviewing, recruiting, and selecting new staff members.

• Oversee induction and orientation programs for newly hired employees.

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

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

• Assist with local resourcing and project allocation efforts.

• Collaborate with project and functional leaders to enhance project operations and address risks to deliverables.

• Provide training on WPDs, SOPs, local requirements, and topics related to clinical operations.

• Identify training deficiencies and ensure compliance with training requirements.

• Ensure adherence to ethical and regulatory standards.

• Notify management of quality issues and assist with quality assurance audits.

• Review clinical operations systems, metrics, KPIs, and project statuses.

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

• Engage in process improvement and development initiatives.

• Guarantee the understanding and facilitation of risk-based monitoring.

• Provide input for bids and the procurement of new business as necessary.

• Collaborate with senior management and executive personnel on strategic planning and business development efforts.

• Lead or participate in initiatives aimed at enhancing departmental and company-wide performance.

⛳️ Requirements

• A minimum of 5+ years of relevant experience.

• At least 1 year of leadership responsibilities.

• Equivalent experience through appropriate education, training, and/or related experience may be taken into account.

• Advanced mentoring, leadership, and supervisory skills are essential.

• Excellent clinical trial monitoring skills, both remotely and on-site.

• Capability to learn and apply company SOPs, WPDs, ICH/GCP, and FDA guidelines.

• Ability to assess medical research data.

• Strong organizational and negotiation capabilities.

• Exceptional attention to detail.

• Advanced written and verbal communication abilities.

• Proficient knowledge of the English language and grammar.

• Competent in computer skills including data entry, archival, and retrieval.

• Willingness to travel as required.

• Excellent team-building, interpersonal, and conflict resolution skills.

• Strong problem-solving abilities in a dynamic environment.

• Familiarity with medical/therapeutic areas and medical terminology.

🏝️ Benefits

• A global team environment.

• Opportunities for collaboration and development.

• A strong commitment to scientific excellence.