Job Description

　　Essential Job Functions:

　　• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, 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.

　　• Manages site activities to ensure delivery of site targets as received from senior management.

　　• Provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.

　　• Responsible for cost efficiencies within the site and all vendor contracts for services at the site.

　　• Continuously oversees the schedules of site staff to ensure highest utilization of all resources.

　　• Evaluates and implements new operational strategies to enhance efficiencies, provide competitive advantages, and improve overall profitability of the site.

　　• May provide input in the feasibility process, considering both recruitment and operational concerns.

　　• Communicates targets to the site teams and continuously measures progress.

　　• Plans and prepares proactively for future studies according to new and defined strategies, embracing and implementing new TA area initiatives at the sites.

　　• Collaborates with site and management regarding capacity planning and back-up plans, arranging and attending meetings.

　　• Ensures patient recruitment activities are adequate for study requirements.

　　• Ensures compliance with the company quality framework, regulatory (GCO) legislation, guidelines and international standards (Global/Local COPS/SOPS)

　　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 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 computer skills with proficiency in Microsoft office and content management software and the ability to learn appropriate software/hardware (i.e. EDC, eCRF and possibly IT/SQL skills but not essential)

　　• Strong attention to detail • Good problem-solving abilities

　　• Good organizational and time management skills

　　• Excellent oral and written communications skills

　　• In-depth perspective and knowledge to represent IGC on task forces or teams

　　• Demonstrated ability to analyze data, determining root cause of deficiencies and providing recommendations for resolution • Skilled in leading process improvement activities

　　• Ability to successfully mentoring and training junior staff

　　• Proficiency in the review and analysis of audit reports

　　• Effective coaching and counselling skills • Ability to read, understand and interpret a protocol

　　• Knowledge of clinical trial process and data management, clinical operations, quality management, and systems applications to support operations

　　• Strong communication skills and business acumen

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