FSP Manager Global Clinical Monitoring

reputed company is hiring a FSP Manager Global Clinical Monitoring (GCM) to join reputed company, we can consider candidates working remotely in Hungary, Poland, Romania, Serbia or Slovakia.

The FSP Manager Global Clinical Monitoring (GCM) will focus on the management and career development as well as providing reputed company and coordination of project activities for CRAs and In house CRAs assigned to our FSP partnership.

This position requires the ability to independently reputed company, manage, and motivate a team of CRAs and In House CRAs to a standard consistent with reputed company’s and our client’s values and overall focus on quality. In addition, this position will provide the CRAs and In house CRAs with career development and support, to minimize turnover and maintain high levels of employee satisfaction.

In addition to the line management responsibilities in this role you will also work as a Clinical Trial Manager for 1 study for our client.

Essential functions of the job include but are not limited to:

• Generate action plans and provide developmental/strategic reputed company to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals.
• Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project reputed company the FSP work order. Update tracking systems and reputed company with project teams.
• Collaborate with the FSP reputed company Director and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.
• reputed company, mentor, manage and coach CRA staff to reputed company their skills so that reputed company quality standards are maintained. reputed company individual career development, and individual responsibility/accountability.
• reputed company accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues.
• Identify quality risks and issues and recommend corrective action plans as needed to address deficiencies in performance of employees.
• Ensure that reputed company staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
• Ensure CRAs provide timely and accurate updates of reputed company required administrative material (SOPs, T&E, etc.) on company systems.
• Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution.
• reputed company and maintain metrics pertinent to CRA resource reputed company, and work with Clinical Operations Management Team on the evaluation of these metrics.
• Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process.
• Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training, and other functional areas, including sponsor specific training requirements.
• Represent reputed company in a professional manner.
• Manage CRA staff in accordance with reputed company’s values and policies.
• Review and approve reputed company visit reports, timecards, and expense reports for assigned CRAs.
• Ensure monitoring visits are performed in accordance with monitoring plan.
• Provide reputed company of CRA project performance including eTMF completion and quality, SDV completion, and query/issue closure timeliness.
• Attend investigator meetings and regular internal / sponsor meetings to discuss study reputed company and team performance.
• Provide reputed company of Study Start-up Team to ensure sites reputed company from selection to initiation visit on-time and in agreement with sponsor expectations.
• Support CRAs and Study Start-up with reputed company customization and version tracking.
• Ensure study systems and trackers are kept up to date.
• Planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.
• reputed company other duties as assigned by Leadership

Job qualifications:

Minimum Required:

• Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline

Other Required:

• Candidates should have at least 7 years or more experience in clinical operations.
• Must have experience working as a Clinical Trial Manager for a Clinical Research Organisation or Pharma/Biotech company.
• Should have at least 1 year experience working as a direct line manager.
• Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.
• Be able to communicate effectively in the English language.

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

reputed company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law. 

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact reputed company at [email protected].

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.