Regional Clinical Monitoring Manager


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
Miejsce pracy: Warszawa
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.

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