Manager, Clinical Operations, Clinical Monitoring

IQVIA Biotech is a global full service CRO, part of the IQVIA family, committed to providing an outstanding service to our clients as well as our employees. We focus on providing excellent training and career development opportunities, encouraging growth from within our talented workforce.

IQVIA Biotech is a specialist unit within the IQVIA CORE that specialise in support and servicing the Emerging Biopharma market. Working with smaller clients on cutting edge therapies. Our hands-on, flexible approach has seen us grow within the market and with that growth we need Managers to support our teams.

We're looking for a passionate, approachable and professional Clinical expert with great people skills and industry knowledge. An opportunity has arisen to be part of the EU Clinical Monitoring Management team and contribute to the overall management of the department and to lead and manage a team of clinical research professionals (Clinical Research Associates in the main, plus Clinical Trials Managers, depending on the experience of the candidate).

BASIC FUNCTIONS:

The main function of the Manager is to work with their team direct reports to assess levels of performance, assess training needs and to coach them through regular one to one meetings to ensure staff are in a position to successfully deliver to their projects in accordance with Good Clinical Practices (GCPs), ICH, Standard Operating Procedures (SOPs), Working Practices (WPs), and policies and procedures set forth by IQVIA Biotech and its clients. All of which forms the basis for interim and end of year appraisals.

The role requires an ability to interact and influence across the business, i.e. with their peer team members, with Clinical Trial Managers, with project team members and on occasions with clients. As a result, the Manager has the opportunity to build a high functioning team, to influence the productivity, efficiency and quality of the department.

MINIMUM RECRUITMENT STANDARDS:

• BSc (or equivalent) in a life sciences program or a nursing qualification with a minimum of 8 years direct experience in clinical studies or equivalent level of education and experience. Understanding of the entire clinical research process mandatory.
• Previous experience in personnel management within a clinical research environment preferred.
• At least 5 years as a Clinical Research Associate, prefer at least 4 years as a successful Lead CRA/Clinical Trial Manager.
• Demonstrated ability to lead and motivate a group of clinical research personnel.
• Excellent organizational, communication (verbal and written), and interpersonal skills.
• Ability to work independently, prioritize and function effectively within a matrix team environment.
• Working knowledge of Word, Excel, and Power Point.
• Prior global/multi region trial management experience is required.
• Prior proposal development and bid defense participation is preferred.
• Prior budget development and management experience is preferred.
• Prior experience in electronic data capture (EDC) is preferred.
• Prior site management experience is required.
• Prior project team leadership/management is required.
• Prior vendor management experience is preferred.
• Prior experience in a Clinical Research Organization (CRO) is preferred.