Site Operations Manager

JOB SUMMARY

The Site Operations Manager is a member of the Site Operations team with process and personnel responsibilities. He/She will direct and oversee research teams.

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

This individual will play a key role in managing the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, the ability to prioritize, a “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team-building skills.

SUPERVISORY RESPONSIBILITIES

• Lead, and manage Site Success personnel, including contract staff when required on multiple concurrent trials and multiple site locations.

ESSENTIAL DUTIES

• Lead, and manage Site Success personnel, including contract staff when required on multiple concurrent trials and multiple site locations.
• Develop strong working relationships and is the point of contact for study staff, clinics and sponsors for study and clinic-related activities
• Contribute content and deliver staff training, and processes (SOPs) and escalate areas of non-compliance or potential non-compliance.
• Collaborate with management peers to ensure agreed deliverables are achieved on time and monitor budget and key performance indicators.
• Provide recommendations on execution aspects of Site Operations, including risk identification and mitigation, to manage study or clinic nuances.
• Maintains confidentiality, embraces diversity, facilitates change, and demonstrates empathy
• Approve vendor bills, review finances, and strategic planning for each site
• Communicate with PI regarding daily Operations, escalating issues to Account Manager to resolve any potential issues or concerns, including financial clarification
• Ensure operational excellence and integrity through adherence to Elligo policies and procedures, client requirements, ICH GCP, Health Canada, EMA, and other relevant regulatory requirements.

KNOWLEDGE SKILLS AND ABILITIES REQUIRED

• BS/BA in Life Science, related discipline, or equivalent work experience
• Previous nursing or management experience in a clinical setting preferred
• CCRC or CCRP certification a plus
• Well versed and current in ICH GCP, FDA, Health Canada (if applicable), EMA (if applicable) and other relevant regulations and guidance that govern clinical trial conduct
• At least 6 years coordinating clinical trials
• Previous supervisory experience is required, and supervisory experience of remotely based staff preferred
• Ability to build and manage teams; able to coach, mentor
• Demonstrated ability in positive relationship building with clients and investigators
• Strong communication and interpersonal skills; experience, comfort, and successful interactions with physicians, nurses, and other medical professionals
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial management systems
• Ability to travel for planning meetings, clinic visits, team meetings, audits, conferences, or client meetings, as required

WORKING CONDITIONS

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.

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

Previous nursing or management experience in a clinical setting preferred

CCRC or CCRP certification a plus

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

At least 6 years coordinating clinical trials

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

Ability to build and manage teams; able to coach, mentor

Demonstrated ability in positive relationship building with clients and investigators

Strong communication and interpersonal skills; experience, comfort, and successful interactions with physicians, nurses, and other medical professionals

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

Ability to travel for planning meetings, clinic visits, team meetings, audits, conferences, or client meetings, as required