Regional Clinical Monitoring Manager

Operational:

• Generate action plans and provide developmental/strategic oversight to optimize monitoring services, with a focus on high-quality delivery of departmental goals;
• Work closely with the Quality group to continually improve and enhance CTM team expectations and procedures to promote quality, consistency, and efficiency in execution;
• Assist Quality group with review and revision of departmental SOPs, working practices, and policies;
• Enforce implementation of current industry practices with regard to monitoring activities;
• Support Quality Group in the organization of training of the CTM team
• Present monthly reports to the company executive board;
• Create and present annual department reports.

Human resource:

• Assist with and contribute to project resourcing to ensure a proper level and allocation of resources is assigned for each project and countries incl. Poland, Hungary, Slovakia, Czech Republic, Belarus and Spain:
• Develop, mentor, manage and coach the Clinical Trial Monitoring team to progress their skills and maintain quality standards;
• Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist with project-specific issues;
• Maintain metrics pertinent to CTM resource oversight, and work with the quality group on the evaluation of these metrics;
• Participate in the hiring process for new CRAs by participating in the interviewing process;
• Assist with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.

Business Development:

• Participate in marketing activities, client presentations, and proposal development;
• Attend professional and industry meetings as a representative of Comac Medical;
• Assist Business Development Manager in the determination of BD strategy for Clinical Trial Monitoring.

• At least 7 years as a Clinical Research Associate/Clinical Monitor, and/or at least 4 years as a successful Lead CRA/Clinical Trial Manager;
• At least 2 years experience providing leadership to people including employees’ development (mentoring), performance management and conflict resolution;
• Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management;
• Working knowledge of current ICH/GCP guidelines, applicable regulations (including country-specific ones), and current industry practices;
• Excellent organizational, communication and interpersonal skills;
• Ability to balance the needs of the organization with the needs of employees;
• Ability to manage multiple priorities within the department;
• Positive attitude and ability to interact with all levels of staff;
• Ability to cope with demanding deadlines in a highly dynamic environment;
• Proficiency in English;
• Working knowledge of Word, Excel, and PowerPoint.

• Great team of knowledgeable, high-achieving and experienced professionals;
• International and diverse work atmosphere;
• Challenging projects in a different therapeutical area as well as in early phases;
• Opportunity to enrich professional skills and progress in career development;
• Work-from-home policy
• Competitive remuneration;
• Professional training.

• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities.