Regional Clinical Monitoring Manager
Comac Medical
Warszawa
kierownik/koordynator
pełny etat
umowa o pracę
rekrutacja online
4 dni temu

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.

If you are interested, challenged, and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

 

Only the shortlisted candidates will be contacted in a timely manner.

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Comac Medical

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a full-service providers of CRO and SMO with headquarter in Sofia, Bulgaria.

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