|Date Posted||February 24, 2021|
|Address||2780 Woods Hollow Rd|
JOB OBJECTIVE: The Interim Clinical Trials Manager will serve as a knowledge resource to provide guidance to the clinical research team and study sites for designated clinical research projects. The Clinical Trials Manager will work closely within the sponsor team to achieve sponsor goals and to support the development and delivery of clinical research activities within the clinical research development program. The Clinical Trials Manager will be responsible for the execution of clinical trials from protocol concept through the clinical study report, and will actively serve as the day-to-day operational lead in the implementation, execution and oversight of Usona sponsored clinical research projects within the Usona clinical research development program.
This is a limited-term contract position (60%-100% FTE) for up to six months, with the potential to convert to a full-time, permanent position.
1. 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. Ensure 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 oversee 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. Participate in Site Selection/ Qualification process.
5. Assist in identifying and selecting appropriate CROs and third party study vendors.
6. Oversee the 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.
7. Ensure that CRO team members, CRA(s) and other third party vendors receive training on all required study related information, including protocols and practices prior to the performance of study related activities.
8. Chair project team meetings with functional leads and oversee the preparation and distribution of meeting agendas/minutes and tracking of action items.
9. Track study related timelines and inform program manager, third party vendors (as applicable) and study sites as needed to ensure studies are carried out according to study protocols, SOPs, ICH/GCP regulations and study-specific manuals and procedures.
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. Oversee the strategy, planning and conduct of investigator meetings (or alternatives) in collaboration with the CRO and relevant third party vendors.
12. Assist with negotiating and managing study budgets and payments in collaboration with the CRO perform an initial review of CRO and other third party study vendor invoices.
13. Serve as a resource for internal/external teams and investigational sites; partner with cross functional teams to achieve sponsor goals.
14. In collaboration with the CRO, oversee the TMF/eTMF set-up, ongoing quality reviews and final reconciliation of study documents including review of site regulatory documents/packages.
15. Ensure that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct.
16. Supervise, mentor, and train new clinical research team members, especially Clinical Trials Associates, as needed.
17. Maintain a high level of familiarity with clinical literature in area of study, and maintain awareness of current developments in scientific and therapeutic area.
18. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
1. Ensure IRB submissions as they pertain to research activities under the purview of Usona (working with a central IRB).
2. Interface with IRB to resolve questions or issues regarding regulatory submissions and review/approval turnaround times, and provide documentation of regulatory activity.
3. Prepare and submit all annual and closeout reports to the IRB on behalf of Usona activities.
4. Maintain clinicaltrials.gov registration.
5. Obtain and maintain WHO Drug and MeDRA licensing.
6. Assist other staff as requested and perform other related work, as needed, including but not limited to: IND submission, reporting and compliance, developing and assisting with study site contractual agreements, and sponsor budget.
1. At least 2 years of trial management experience.
2. At least 6 years of clinical trial experience.
3. Bachelor’s degree with combination of education/experience in science or health-related field required.
4. Current Certified Clinical Research Professional (CCRP) certification (or equivalent), or will receive CCRP certification within 1 year of employment.
5. Working knowledge of GCP/ICH guidelines and the clinical development process.
6. Excellent communication skills, detail oriented.
1. Ability to use telephone and computer equipment.