Manager, Clinical Operations

Avania is the only global CRO built for MedTech — integrating regulatory strategy, clinical development, and market access and reimbursement to take innovations from concept to commercialization with confidence. Avania was purpose-designed to serve medical technology innovators, combining regulatory, clinical, engineering, and market access expertise to guide products across the full lifecycle

Join our team of subject matter experts and contribute to the development of life-changing medical devices that improve patients' lives worldwide.

Avania - MedTech's trusted Champion

Avania are hiring – Manager, Clinical Operations

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, Sr. CRA and Lead CRA) and/or of Clinical Trial Associates. 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.

The Clinical Operations Manager contributes to, and participates in, the marketing of AVANIA services, as needed. Assures compliance with Good Clinical Practices (GCPs), ICH, ISO 14155, MEDDEV, Standard Operating Procedure (SOPs), Working Practice Guidelines (WPGs), and policies and procedures set forth by AVANIA and its clients.

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, by 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.

Competencies

• 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.

#LI-DNI