Clinical Trial Assistant

Job Type

Full-time

Description

Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases.

The Opportunity: Clinical Trial Assistant:

The Clinical Trial Assistant (CTA) will provide support to the Global Clinical Trial lead and other members of Clinical Development/Clinical Operations in the start-up, execution, and closeout of the clinical trial. He/she may also provide administrative support to the functional team as needed

What You Will Contribute

• Develops and maintains study tools including trackers, spreadsheets, and filing systems for various studies.
• Creates, maintains, and tracks information for keys study activities and needs (e.g., study contact list, site start-up, enrolment, histological slides, etc.).
• Assists with meeting coordination and preparation activities; take, finalize, and file meeting minutes as needed.
• Assists in Site Qualification and Site Selection Activities.
• Oversees the preparation, distribution and follow-up with investigative sites for essential documents.
• Confirms distribution of safety reports.
• Contributes to the development of study-related documents and tools.
• Oversees the ordering, distribution and tracking of trial materials, e.g., eDiaries, lab supplies.
• Provides administrative support to the Clinical Operations Team.
• Provides oversight of regulatory documents required for Local/Central IRB Submissions, EC Submissions, through investigational product greenlight/ release to ensure completeness and quality.
• Reviews regulatory documents to support site updates to the IND.
• Ensures TMF Inspection readiness.
• Assists with creation of TMF Index and TMF Plan.
• Conducts periodic TMF document content review for completeness.
• Ensures documents are filed in the correct locations and file naming conventions are correct.
• Assists with quality reviews of TMF.
• Assist in the archiving of study documentation for the TMF.
• May help with coordination of Meetings, and responsible for Agendas, and Meeting Minutes.
• Assists in tracking milestones, generating study metrics, and providing written and verbal updates to Management.
• Liaises with Clinical Project Manager and/or others to resolve study related discrepancies and issues.
• Ensures adherence to pertinent regulatory requirements and to departmental polices, practices and procedures. Ensures knowledge is kept up to date by reading SOP's and maintaining awareness of GCP guidelines.
• Ensures program meets all GCP/ICH Guidelines and is Inspection Ready Essential.
• May participate in the development of SOPs, Work Practices and Work Instructions.
  
  

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).
• 2+ years’ experience in the described contributions.
• Good understanding of principles of good clinical practice.
• Knowledge and experience in overseeing and/or maintaining a TMF.
• Demonstrated computer skills in relevant IRT, EDC and other third-party systems.
• 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.
• 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 work with large databases.
  
  

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 $70,000 - $90,000. 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 [email protected].