Clinical Operations Manager - Usona Institute

JOB OBJECTIVE: The Clinical Operations Manager supports the execution of clinical research activities in collaboration with the clinical operations team, CRO, Vendors and study sites under the guidance of senior staff. The Clinical Operations Manager works closely within the sponsor team to achieve sponsor goals and to support or manage the development and delivery of clinical research activities within the clinical research development program. The Senior Clinical Operations Manager supports or provides trial oversight for the execution of clinical trials from protocol concept through the clinical study report and actively supports the operational lead in the implementation, execution and oversight of Usona sponsored clinical research projects within the Usona clinical research development program. The Clinical Operations Manager works under the supervision of a Senior Clinical Operations Manager or Director and is expected to conduct their assigned tasks with moderate to minimal oversight.

CORE DUTIES:

1. Support or manage operational aspects and progress of clinical trials including study planning, site selection/qualification, study execution and end of study activities in collaboration with applicable Usona and CRO project teams.

2. Support or manage the development of progress reports to summarize study progress, accomplishments and risk mitigation activities and ensure distribution to the Usona Senior Management team.

3. Assist with writing and/or supports the development of clinical protocols, amendments, informed consent forms, study related plans, and any other clinical research related documents to ensure alignment with study requirements.

4. Assist with sponsor oversight of site monitoring activities, including clinical monitoring plan development, CRA selection, monitoring visit report review, and may conduct or attend site visits.

5. Support or manage the CRO and third-party study vendor selection process, from RFP through to final selection, coordinating with internal and external cross-functional team members.

6. Support or oversee specific responsibilities and performance of CROs, third party vendors, and other team members, as assigned to ensure compliance with study protocol and in accordance with scope of work. Escalates issues and risks to senior team members.

7. Support the training of CRO team members, CRA(s) and other third-party vendors on all required study related information, including protocols and practices prior to the performance of study related activities.

8. Participate in project team meetings and contribute to agenda/minutes.

9. Track study related timelines and inform cross-functional team members, third-party vendors (as applicable) and study sites as needed to ensure studies are conducted within timelines and scope.

10. Develop and maintain good working relationships with third-party vendors, investigators and study staff and ensure that recruitment/retention is in alignment with the applicable plan.

11. Supports the strategy, planning and conduct of investigator meetings (or alternatives) in collaboration with the CRO and relevant third-party vendors.

12. Assist in reviewing third-party vendor invoices and may manage specific aspects of a study budget .

13. Serve as a resource for internal/external teams and investigational sites; partner with cross functional teams to achieve sponsor goals.

14. Track and coordinate trial related materials, including investigational product, clinical trial supplies, and laboratory samples.

15. In collaboration with the CRO, maintain audit-readiness at all times.

16. Ensure that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct; Provide support for audit and inspection activities

17. Support onboarding of junior team members as directed.

18. Understand and comply with ethical, legal and regulatory requirements applicable to our business, and that studies are conducted per SOPs, ICH/GCP regulations and study-specific manuals and procedures.

19. Oversee the TMF/eTMF set-up, ongoing quality reviews and final reconciliation of study documents including review of site regulatory documents/packages.

Special Projects:

20. May lead or support special projects depending on business needs, such as:
* Trial master file set-up and maintenance
* Preparing for and maintaining inspection and audit-readiness
* Data monitoring and review
* Site support and outreach

Emotional and Social Intelligence:

21. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

22. Embracing and being open to incorporating Emotional & Social Intelligence (ESI) core principles in daily work.

23. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. At least 7 years of clinical research, trial management, trial coordination or clinical operations experience.

2. At least 2 years of clinical operations trial experience or an equivalent combination of education, training, and relevant experience may be considered in lieu of the stated requirements.

3. Bachelor's degree with combination of education/experience in science or health-related field required.

4. Working knowledge of GCP/ICH guidelines and the clinical development process.

5. Excellent communication skills, detail oriented.

PHYSICAL DEMANDS:

1. Ability to use telephone and computer equipment.

At Usona, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.