COMAC MEDICALis one of the most reputable, full-service providers of CRO and SMO, established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals.
Recognizedas a leader in clinical research we are proud to provide innovative and non-conventional solutions of high quality for the pharmaceutical industry.
An inspiring and strategic job opportunity for
Regional Clinical Monitoring Manager
Responsibilities:
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.
What is required for the role?
- 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.
Why join Comac Medical?
- 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.
Core strengths of Comac Medical
- Proven track record for quality and delivery;
- Established and trusted relationships with KOLs;
- Motivated, capable and dedicated team;
- Global full-service capabilities.
