Clinical Operations Manager – FSP

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

📋 Description

• Oversees staff by providing guidance, mentorship, and direction in their work.

• Conducts regular evaluations of performance and career discussions with team members, facilitating their professional growth.

• Responsible for interviewing, recruiting, and selecting new staff members.

• Manages and executes induction/orientation programs for all new hires, ensuring their seamless integration into the organization.

• Ensures that all staff CVs, training records, position descriptions, and experience profiles are accurate and up-to-date. Monitors the timeliness and precision of timesheets and expense reports.

• Aids in allocation activities according to the local resourcing process and supports project leads/functional leads to enhance the operational efficiency of projects.

• Appropriately raises any concerns that may affect project deliverables.

• Provides training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements, and other subjects affecting clinical operations. Identifies training gaps and ensures compliance with training needs, potentially contributing to the development of training programs as necessary.

• Ensures compliance with ethical and regulatory standards.

• Notifies management of quality issues, requests QA audits as needed, 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.

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

• Engages in initiatives aimed at process improvement and development.

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

• May provide input on bids and assist in the acquisition of new business as required.

• Collaborates with senior management in clinical operations and executive staff on strategic planning and business development as necessary.

• May lead or contribute to initiatives that improve departmental performance or drive process enhancements across the organization.

⛳️ Requirements

• Prior experience that equips the individual with the knowledge, skills, and abilities necessary for the role (equivalent to 5+ years).

• At least 1 year of leadership experience.

• Advanced mentoring, leadership, and supervisory capabilities.

• Exceptional clinical trials monitoring skills, both remotely 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 ability to assess medical research data.

• Strong organizational and negotiation abilities.

• Keen attention to detail.

• Advanced written and verbal communication skills.

• Proficient knowledge of the English language and grammar.

• Demonstrated competence in using computers for tasks including data entry, archiving, and retrieval.

• Willingness to travel as required.

• Excellent team player with skills in team building.

• Strong interpersonal and conflict resolution skills.

• Advanced capability to employ problem-solving techniques in a constantly evolving environment.

• Solid understanding of medical and therapeutic fields and medical terminology.

🏝️ Benefits

• Accessibility/Disability Access

• Equal Opportunity Employer