FSP Manager, Clinical Operations

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

📋 Description

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

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

• Act as the primary point of escalation for performance-related concerns and training requirements.

• Work in partnership with leadership to address resourcing needs.

• Guide staff through coaching, mentorship, work direction, performance evaluations, and discussions about career advancement.

• Facilitate employee career progression and take part in the interviewing, recruiting, and selection of staff.

• Oversee the induction and orientation processes for new employees.

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

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

• Support allocation efforts and lead project/functional activities to enhance project operations.

• Raise issues that could impact project deliverables.

• Provide training on WPDs, SOPs, local regulations, and clinical operations subjects.

• Identify training deficiencies and ensure training prerequisites are satisfied.

• Guarantee compliance with ethical and regulatory standards.

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

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

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

• Engage in process improvement and development initiatives.

• Ensure comprehension and facilitation of risk-based monitoring.

• Assist with bids and the procurement of new business as necessary.

• Collaborate with senior management and executive teams on strategic planning and business growth.

• Lead or contribute to initiatives aimed at enhancing departmental and company performance.

⛳️ Requirements

• A minimum of 5+ years of relevant experience.

• At least 1 year in a leadership role.

• Equivalent experience may include a mix of appropriate education, training, and/or directly related experience.

• Advanced skills in mentoring, leadership, and supervision.

• Excellent abilities in clinical trials monitoring.

• Understanding of, or capacity to learn, SOPs, WPDs, and pertinent regulations including ICH/GCP and FDA guidelines.

• Ability to assess medical research data.

• Strong organizational and negotiation abilities.

• Exceptional attention to detail.

• Advanced written and verbal communication skills.

• Proficient knowledge of the English language and grammar.

• Computer proficiency including data entry, archival, and retrieval capabilities.

• Willingness to travel as necessary.

• Strong team-building competencies.

• Skills in interpersonal relations and conflict resolution.

• Effective problem-solving abilities in a dynamic environment.

• Familiarity with medical/therapeutic areas and medical terminology.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Chance to contribute to scientific excellence and innovation.