Job Description

　　Qualifications:

　　Education and Experience:

　　Bachelor's degree or equivalent and relevant formal academic / vocational qualification

　　Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years). 1+ year of leadership responsibility. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

　　Knowledge, Skills and Abilities:

　　• Advanced mentoring/leadership/supervisory skills

　　• Excellent clinical trials monitoring skills; Remote and on-site

　　• Demonstrated understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations

　　(e.g. ICH/GCP, FDA guidelines)

　　• Demonstrated ability to evaluate medical research data

　　• Strong organizational and negotiation skills

　　• Strong attention to detail

　　• Advanced written and oral communication skills

　　• Good knowledge of English language and grammar

　　• Demonstrated use of computer to include data entry, archival and retrieval

　　• Ability to travel as needed

　　• Excellent team player with team building skills

　　• Excellent interpersonal and conflict resolution skills

　　• Advanced ability to utilize problem-solving techniques applicable to constantly changing environment

　　• Solid knowledge of medical/therapeutic areas and medical terminology

　　Essential Functions

　　• Manages staff, providing coaching, mentorship and work direction.

　　• Conducts regular performance appraisals and career discussions with staff • • • Manages and conducts induction/orientation programs for all new employees (CRAs and CTCs), ensuring their smooth assimilation into the company.

　　• Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date.

　　• Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects.

　　• Escalates appropriately any issues which may impact project deliverables.

　　• Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.

　　• Participates in process improvement/development initiatives.

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

　　• Alerts management to quality issues, requests QA audits as appropriate, and supports direct reports and project team in providing audit responses as required.

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

　　• Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.

　　• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.