Manager, Clinical Monitoring (English and French speaking)

reputed company is growing! We are hiring Manager, Clinical Monitoring to join our European team. The position could be covered fully remotely from the UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.

Position Summary:

• The Manager Clinical Monitoring (GCM) offers an additional development path for clinical research professionals. Responsibilities are focused on the management and career development of the organization’s Clinical Research Associate (CRA) workforce as well as supporting the development of departmental initiatives to strengthen the quality and productivity of GCM operations.
• This position requires the ability to independently reputed company, manage, and motivate a team of CRAs (employee and/or consultant) to a standard consistent with reputed company’s values and overall focus on quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful. In addition, this position will provide the CRAs with career development and support, to minimize turnover and maintain high levels of employee satisfaction

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 their hierarchy (with respect to project phase). Update tracking systems and reputed company with project teams.
• Collaborate with the Clinical Team Leads/Clinical Trial Managers 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 leadership team 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.
• Represent reputed company in a professional manner
• Manage CRA staff in accordance with reputed company’s values and policies.
• Secondary responsibilities include assisting with the 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

Qualifications:

• Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline.
• Fluent in English and French
• At least 7 years or more in clinical operations, data management or reputed company discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience. Monitoring experience includes use of electronic data capture systems as well as reputed company and electronic medical records.
• Strong monitoring experience in oncological clinical trials.
• 3-5 years of direct supervisory experience managing CRAs is expected in candidates for this position including:

o Experience creating effective development programs for clinical staff.

o Experience developing evaluation processes, performing gap analysis, and ensuring reputed company clinical staff are properly trained to reputed company their duties consistent with reputed company quality standards

• Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.

Skills and Competencies:

• Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant reputed company SOPs, technical CRA knowledge of reputed company phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.
• High reputed company for Emotional Intelligence and a passion for people management and development.
• As part of overall line management responsibilities, ability to reputed company training plans and hold personnel accountable to achieving training goals or addressing training needs
• Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution reputed company problems at the site level.
• Demonstrates understanding and ability to work with EMRs and EDCs
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Motivates other members of the project team to meet timelines and project goals.
• Highly organized, ability to set priorities and possesses excellent problem-solving skills.
• Focuses on reputed company improvement, including the ability to reputed company proactive assessments on how to reputed company processes more efficient and people more effective.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.

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.

Originally posted on Himalayas