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Senior Clinical Monitoring Project Lead

Job Field:
Clinical Research Jobs
Clinical Study Coordinator Jobs, CRA Jobs, Clinical Research Associate Jobs
Belgium, France, Spain, Ireland, United Kingdom
Belgium All, France All, Spain All, All England
Contract Type:
Salary Description:
Inventiv Health
Job Ref:

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.

Position Overview
As Senior Clinical Monitoring Project Lead, you will provide leadership and technical support to Clinical Monitoring teams to ensure the quality of all Clinical Monitoring deliverables, and the achievement of financial goals are met.
As the successful candidate, you will have previous experience of working as a CMPL/Study Manager or equivalent, within a CRO environment and be ready for the next level of responsibility.

• Coordination of project leads working across regions and/or countries to deliver study results to clients
• Interact with the client and other functional departments to ensure good communication
• Align clinical activities to budget
• Support the development of study materials and present at Investigator and study launch meetings
• Review monitoring reports within the timelines mandated by SOP’s or monitoring plans
• Support business development by participating in proposals and bid defense meetings
• Responsible for the quality of clinical monitoring deliverables within a project and maintaining proper visibility of its progress by use of the tracking tools
• Ensure efficient dissemination of information across the CRA team
• Support the identification of out of scope activities including the completion of clinical monitoring aspects of change orders
• Act as project managers on regional studies with limited scope of work
• Develop and deliver project level CRA training , clinical monitoring plans, monitoring aids and annotated visit reports
• Oversee the development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring and coaching
• Set priorities and schedule activities of departmental resources, implement company objectives and create alternative solutions to address business and operational challenges

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Extensive clinical monitoring experience, including a significant amount of time as Clinical Monitoring Project Lead/Study Manager or equivalent
• Demonstrated ability for leading and aligning teams in the achievement of project milestones
• Demonstrated ability for working in an international environment, across regions, countries and time zones
• Knowledge of basic financial principles
• Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Strong Organisational Skills
• Must demonstrate good computer skills
• Excellent communication, presentation and interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

• A competitive remuneration package with excellent benefits
• A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
• The opportunity to work within a successful and rewarding environment

Closing Date:

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