Clinical Operations Manager

Avania; Bilthoven; On-site; EUR 90,000 - 130,000; Full time

Job summary

Avania is seeking a Clinical Operations Manager in the Netherlands to provide line management of Clinical Research Associates (CRA I–Sr.) and Site Managers, and to support the Director and Functional Head. You will drive performance, career development, and training across the clinical operations team, guiding projects and ensuring adherence to ICH/GCP/ISO guidelines.

The role requires strong leadership, excellent communication, and the ability to navigate a matrix organization while traveling

Qualifications

• BS/BA in life sciences or RN/BSN with 5+ years direct clinical experience.
• Understanding of the entire clinical research process mandatory.
• Experience in personnel management within a clinical research environment preferred.
• At least 3 years, but 5 years preferred, as a CRA/Clinical Monitor, preference in MedTech.
• Ability to lead and motivate a group of clinical research personnel.
• Excellent organizational, communication, 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 preferred.
• 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.
• Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff.
• Ability to balance needs of the organization with needs of staff.
• Ability to protect confidential/sensitive information.
• Ability to manage multiple priorities within the department and across staff.
• Ability to reason independently for assessing and recommending specific solutions in clinical settings.
• Ability to mentor and train clinical staff.
• Understanding of basic data processing functions, including electronic data capture.
• Working knowledge of Word, Excel, and Power Point.
• Working knowledge of current ICH/GCP/ISO14155 guidelines and applicable country specific regulations.
• Willingness and ability to travel domestically and internationally as required.

Skills

Staff leadership

Clinical research processes

Communication skills

Project management

Budget management

EDC systems

Regulatory knowledge

Multiregional trial experience

Mentoring

Negotiation

Education

BS/BA in life sciences or RN/BSN

Tools

Word

Excel

PowerPoint

Job description

Avania are hiring – Clinical Operations Manager

The main purpose of the Clinical Operations Manager role is to provide line management of Clinical Research Associates of all levels (CRA I, CRA II and Sr. CRA) and/or of Site Managers. In addition, this position provides departmental-level support to the Director and Functional Head.

The key role of Clinical Operations Manager will work with Clinical Operations Management staff to ensure the successful management, performance, and career development of Lead & Sr. Clinical Research Associates, Clinical Research Associates (I & II)(CRAs) and / or Clinical Trial Associates (CTAs).

As the Clinical Operations Manager you will provide training and consultation related to clinical operating activities in the conduct of clinical trial projects. You will serve as a source of clinical research expertise for AVANIA clinical staff.

Candidates who offer any combination of the skills, knowledge and experience listed below, are encouraged to apply for the role of Clinical Operations Manager, with our continued growth we are hiring talent to join us on our journey and grow with us.

Education/Function Requirements

• BS/BA (or equivalent) in a life sciences program or RN/BSN (or equivalent) with a minimum of 5 years direct experience in clinical studies or equivalent level of education, training and experience. Understanding of the entire clinical research process mandatory.
• Previous experience in personnel management within a clinical research environment preferred.
• At least 3 years, but 5 years preferred, as a Clinical Research Associate/Clinical Monitor, preference in medical devices, diagnostics, or MedTech.
• 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 preferred.
• 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.
• Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff.
• Ability to balance needs of the organization with needs of staff.
• Ability to protect confidential/sensitive information.
• Ability to manage multiple priorities within the department and across staff.
• Ability to reason independently for assessing and recommending specific solutions in clinical settings.
• Ability to mentor and train clinical staff.
• Understanding of basic data processing functions, including electronic data capture.
• Working knowledge of Word, Excel, and Power Point.
• Working knowledge of current ICH/GCP/ISO14155 guidelines and applicable country specific regulations.
• Willingness and ability to travel domestically and internationally as required.