Careers

JOB SUMMARY  

The Associate Director of Research Operations (ADRO) is a senior member of the Research Operations team with process and personnel responsibilities. 

This person will work closely with the Leadership from Practice Success and Project Management and other Research Operations leaders to ensure all sites and studies are adequately and appropriately resourced and delivered efficiently to timeline, budget and quality expectations. The ADRO will provide study management expertise and mentor Operations Managers, Study Managers, Site Development Specialists and other Research site-based staff. 

The ADRO will be a key contributor to the strategic and functional objectives of the department. These clinical trials may be conducted across physically separate clinics across multiple geographic areas to achieve study objectives and corporate goals. 

The ADRO is a results-oriented, problem-solver who fosters business and administrative relationships with Elligo Research practice and health system partners, interacts with Corporate Leadership, Investigators, and Healthcare Administrators.  The ADRO coordinates growth and development of research programs within assigned practices by engaging new investigators, identifying additional therapeutic areas, adding more equipment and/or facilities, and assisting in the development of robust practice-based clinical trial programs. 

Responsibilities may include, but are not limited to: 

• Lead and manage Research Operations personnel, including contract and partner company staff when required. 

• Develop and refine staff training, processes (SOPs, and technology systems requirements, training & implementation to streamline efficiency, consistency, and scalability of Elligo operations. 

• Collaborate with management peers to ensure agreed deliverables are achieved on time and monitor budget and key performance indicators. 

• Provide input to proposals for project bids to ensure projects can be managed within agreed upon schedules and objectives achieved. 

• Provide recommendations on executional aspects of research operations, including risk identification and mitigation, to manage study or clinic nuances. 

• Ensure operational excellence and integrity through adherence with Elligo policies and procedures, client requirements, ICH GCP, , Health Canada, EMA and other relevant regulatory requirements. 

Qualifications and Education Requirements 

•  BS/BA in Life Science, related discipline or equivalent work experience 

• Previous nursing or management experience in a clinical setting preferred 

• Well versed and current in ICH GCP, FDA, Health Canada, EMA and other relevant regulations and guidance that govern clinical trial conduct 

• 8+ year’s pharmaceutical/biotechnology experience in drug development. 

• Previous supervisory experience required, and supervisory experience of remotely based staff preferred 

• Proven track record building and managing teams; able to coach, mentor and provide career development guidance to staff 

• Able to marshal resources and inspire teams to achieve collaborative goals 

• Demonstrated ability in positive relationship building, with strong verbal and written skills required 

• Strong communication and interpersonal skills; experience, comfort and successful interactions with physicians, nurses, other medical professionals, healthcare provider office administrators, and vendors providing services/technology to healthcare providers (e.g., EHR, RCM, PM, Labs, and Suppliers/Distributors 

• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial management systems 

• Ability to travel for recruitment, clinic visits, staff QC activities, team meetings, conferences or client meetings, as required 

WORKING CONDITIONS 

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers. 

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand. 

Regular travel (25-50%) travel is required for this position. 

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position.   They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel.  More in-depth information can be found in SOP's, working guidelines, policies, etc. 

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.