Clinical Operation Manager, FSP

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

📋 Description

• Oversees staff by providing coaching, mentorship, and work guidance.

• Conducts regular performance evaluations and career discussions with team members.

• Facilitates the career development of employees.

• Responsible for interviewing, recruiting, and selecting candidates.

• Manages and implements induction/orientation programs for all new hires, ensuring their smooth integration into the company.

• Ensures that all staff CVs, training records, position descriptions, and experience profiles are comprehensive and current.

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

• Supports allocation activities according to the local resourcing process.

• Aids project leads and functional leads in optimizing project operations.

• Appropriately raises any issues that could affect project deliverables.

• Provides training on Working Practice Documents (WPDs), Standard Operating Procedures (SOPs), local requirements, and other subjects relevant to clinical operations.

• Identifies training needs and ensures they are addressed.

• May assist in developing training programs as necessary.

• Ensures compliance with ethical and regulatory standards.

• Notifies management of quality concerns, requests QA audits when necessary, and facilitates both client and internal quality assurance audits as required.

• Manages and reviews systems (e.g., Activate, CTMS, Preclarus, Clarity) to assess employee and project metrics, KPIs, and overall project status.

• Evaluates staff performance, including conducting PAVs (either remotely or on-site) to thoroughly assess employee monitoring skills and project execution when applicable.

• Engages in process improvement and development initiatives.

• Ensures comprehension and facilitation of the risk-based monitoring approach.

• May provide input on bids and assist with acquiring new business as needed.

• Collaborates with senior management in clinical operations and executive staff for strategic planning and business development when required.

• May lead or contribute to initiatives aimed at enhancing departmental performance or driving process improvements throughout the company.

⛳️ Requirements

• Prior experience that equips the candidate with the knowledge, skills, and abilities to perform the job (equivalent to 5+ years).

• At least 1 year of leadership experience.

• Advanced mentoring, leadership, and supervisory capabilities.

• Exceptional clinical trials monitoring skills, both remote and on-site.

• Proven understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations (e.g., ICH/GCP, FDA guidelines).

• Demonstrated capacity to evaluate medical research data.

• Strong organizational and negotiation skills.

• High attention to detail.

• Excellent written and verbal communication skills.

• Proficient knowledge of the English language and grammar.

• Proven experience with computers, including data entry, archiving, and retrieval.

• Willingness to travel as necessary.

🏝️ Benefits

• Health insurance

• Professional development opportunities