Key Skills

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. 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.

Core Responsibilities

Manage and develop clinical research staff, including CRAs and/or Site Managers, and support the Clinical Operations Director and Functional Head. Provide training and clinical research expertise, and work with clinical operations management to ensure effective trial delivery and staff performance.

Requirements

Requires a life sciences bachelor's degree or equivalent, at least five years of direct clinical study experience, at least three years as a CRA or Clinical Monitor, and prior site management and project team leadership experience. Candidates should understand the full clinical research process, demonstrate strong leadership and communication skills, and have working knowledge of ICH/GCP/ISO 14155 guidelines; global trial, CRO, vendor, budget, proposal, and EDC experience is preferred.