Clinical Trial Manager/Sr. Manager

Job Type

Full-time

Description

The Clinical Trial Manager/Sr. Manager is responsible for leading operations for one of more clinical studies. This position will lead the day-to-day operations of assigned clinical studies, including start-up, conduct, and close out activities. This is a great opportunity for someone to continue to develop their career in an exciting, growing, and fast paced environment.

What You Will Contribute

• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives. This includes managing clinical research organizations to ensure timely and quality deliverables.
• Lead internal cross-functional study team for assigned studies.
• Support or lead feasibility assessment and selection of countries and sites for study conduct.
• Performs timely review of monitoring reports and associated deliverables demonstrating sponsor oversight.
• Develop, or support the development of, study related clinical documents, including informed consent forms, site training materials, clinical monitoring plans, and source document templates.
• Oversee the Inspection Readiness of the TMF by assisting with periodic reviews of the TMF.
• Participate in data reviews and the review of case report forms statistical analysis plans.
• Supports financial management of assigned studies, including the review and negotiation of clinical site budgets, review and approval of site and vendor invoices, and the participation in accrual reviews to track the financial status of the study against budget.
• Perform co-monitoring visits with CRO, as needed, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits.
• Participate in the development, review, and implementation of departmental SOPs and processes.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Evaluate and resolve site performance, quality or compliance problems and escalate per defined process as appropriate in collaboration with clinical operations management.
• Work with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
• Provide mentorship/guidance to team members or cross-functional colleagues on study processes/study requirements.
  
  

What We Seek

• BS/BA degree or Associates degree in a health-related field (e.g., RN, biological science, or pharmacy, or other health related discipline).
• 5+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required.
• Must have detailed knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive.
• Excellent knowledge of clinical operations across Phase 1-3, specifically conducting clinical studies from start-up through close-out.
• Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion.
• Strong oral & written scientific communications skills.
• Good presentation skills for diverse audiences (investigator meetings, site personnel, KOL interactions and internal project teams).
• Ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team.
• Excellent project management skills.
• Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.
• Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems.
• Ability to travel if necessary.
  
  

What We Provide To You

• The opportunity to make a difference in people’s lives impacted by autoimmune and inflammatory diseases.
• Participate in a team of life science professionals who value science, data, high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency.
• Competitive compensation and a comprehensive benefit package, including stock options.
  
  

The anticipated annual base salary range for this role is $120,000 to $180,000. Final compensation depends on multiple factors including, but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, company needs, and market factors. Ventyx is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, LTD, time off, a retirement plan, and other voluntary benefits for employees.

Ventyx is an equal opportunity employer and strives to maintain a work environment in which all individuals are treated with respect and dignity. Qualified applicants will receive consideration for employment without regard to race, age, ethnicity or national origin, color, religion, sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender identity, sexual orientation, disability or medical condition (including genetic information or characteristics or those of a family member), military service or veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Notice To Recruiters And Agencies

The Human Resources team manages the recruitment and employment process for Ventyx Biosciences. To protect the interest of all parties involved, Ventyx Biosciences does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing or recruiting agencies or fee-based referral services. The submission of referrals or resumes by anyone other than a candidate directly to Ventyx Biosciences’ employees is strictly prohibited. Unsolicited referrals and resumes sent to Ventyx are deemed gratuitous, and do not obligate Ventyx to pay fees should we hire from those resumes. Recruiters are requested NOT to contact or present candidates directly to our hiring managers or employees. Please direct all inquiries to careers@ventyxbio.com.