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Clinical Trial Manager - Usona Institute
Madison, WI
Job Description
JOB OBJECTIVE: The Clinical Trial Manager (CTM) reports to the Director of Clinical Operations and provides trial oversight of investigational sites, CROs and vendors. This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans. The CTM will also be responsible for monitoring all phases of clinical studies, as needed. The ideal candidate will demonstrate a drive and interest in bridging their clinical operations background with the unique demands of psychedelic research. This position will also provide input, support and maintenance of department clinical projects and infrastructure. CORE DUTIES: 1. Vendor (e.g., CRO, Biometrics, IRT, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives and goals covering multiple regions. 2. Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department. 3. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents for global regions. 4. Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial. 5. Obtains and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. 6. Participates & provides input on study site selection activities. 7. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure. 8. Performs remote and on-site monitoring & oversight activities using various tools to ensure: 9. Data generated at sites is complete, accurate and unbiased 10. Subjects' right, safety and well-being are protected. 11. May conduct site visits, including but not limited to, site selection, site initiation, interim monitoring, close-out, CRA oversight, and co-monitoring. Records in support of these monitoring visits must be timely, clear, comprehensive and accurate. 12. Performs timely review of monitoring reports and associated deliverables demonstrating sponsor oversight. 13. Collects, reviews, and monitors required regulatory/operational documentation for study start-up, study maintenance and study close-out. 14. Supports clinical document control activities and associated study staff to ensure the content and management of the electronic/paper Trial Master File (eTMF/TMF) is current and inspection-ready. 15. Perform periodic reviews of the eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines. 16. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. 17. Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined process as appropriate in collaboration with clinical operations management. 18. Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. 19. Tracks and coordinates trial related material availability, including clinical trial supplies and laboratory samples 20. Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. 21. Supports financial management of the study which includes review and approval of site and vendor invoices. 22. Supports risk Management initiatives 23. Supports audit/inspection activities as needed. 24. Maintain clinical trial registry entry/updates, as required. 25. Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements. 26. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 27. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work. 28. Understands and complies with ethical, legal and regulatory requirements applicable to our business. (This should be the last numbered statement under the Core Duties) KEY QUALIFICATIONS: 1. BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered. 2. 5 years of direct site management (monitoring) experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through 4 studies, both domestic and international. 3. 3-5 years study oversight as an in-house CTM (e.g., CRO/vendor oversight) 4. At the CPM level they must have managed clinical studies/programs with multiple vendors. 5. Exceptional speaking, listening, and writing communication skills. 6. Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out. 7. Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. 8. Demonstrated ability to work independently and in a team environment and exhibits initiative with a positive and proactive approach. 9. Demonstrated ability to mentor/lead. PREFERRED QUALIFICATIONS: 1. The candidates must have provided CRO oversight at a sponsor company. 2. Previous experience with a sponsor company. 3. Experience in CNS and/or psychedelic trials. 4. In-house preferred. 5. Travel up to 30% with overnight stays. Diversity is important at Usona. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
2 to 5 years
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