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Sr. Clinical Trial Manager in San Diego, California at ADARx Pharmaceuticals Inc.

NewSalary: $125000 - $160000
ADARx Pharmaceuticals Inc.
San Diego, California, 92121, United States
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Job Description

We are seeking a highly motivated and qualified individual to join our Clinical Department as a Sr. Clinical Trial Manager and work as part of a team to drive success. The successful candidate must have experience managing Phase I-III clinical trials and a comprehensive knowledge of clinical operations, ICH/GCP and FDA regulatory requirements. This position is responsible for supporting the effective planning and conduct of one or more ADARx Pharmaceuticals clinical trials in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and applicable regulatory requirements.

Essential Responsibilities:

  • Develop and promote a workplace culture that values diversity of thought, promote integrity and create an atmosphere that supports coaching and fosters accountability.
  • Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
  • Communicate directly with trial site staff and investigators to support the relationship between the sponsor and site and co-monitor or participate in Sponsor oversight visits.
  • Provide oversight of CRA/CTA assigned to clinical trials and provide oversight of activities related to site qualification, initiation, interim monitoring, and close-out visits, as needed.
  • Plan and participate in Monitor and Investigator Meetings.
  • Develop and/or provide input to trial plans, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Protocol Deviation Plan, etc.
  • Support the management, tracking and oversight of clinical site budgets/payments in relation to conduct of a clinical trial.
  • Track progress against project timelines, generate regular status updates, and communicate progress and issues to management.
  • Review protocol deviations and data listings; Perform clinical data review of patient profiles, data listings and summary tables, including query generation.
  • Review monitoring reports for compliance with study protocols and GCP.
  • Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to Clinical Team Members as appropriate.
  • Maintain and report metrics for trial tracking and clinical site performance, including patient recruitment and retention.
  • Develop or provide input to patient information/consent, eCRF forms and completion guidelines, site instructions for specimen collections, study drug order forms, etc.
  • Review and/or approve of IP release packages.
  • Support safety reporting.
  • Reviews and recommend updates for departmental SOPs, may draft updates to SOPs depending on experience and level.
  • CRO management and oversight.
  • Responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with Clinical Team Members.
  • Establish vendor management plans and review quality metrics.
  • Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience.
  • Train and mentor entry-level staff.
  • Maintain all appropriate corporate standards for facility safety and hazardous material management.
  • Other duties as assigned.

    • Essential Physical Characteristics:

    Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

    On-Site Protocol:

    Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

    Qualifications:

  • BS/MS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent).
  • 8+ years of combined managing/monitoring Phase 1, 2, and 3 clinical trials.
  • Strong knowledge of and strategic clinical operations.
  • Strong experience with clinical study conduct from start-up through close-out, with global trial and CRO management experience.
  • Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements.
  • Experience in performing clinical site monitoring visits, including remote visits.
  • Experience in CRO/Vendor management (domestic/international) monitoring of budget scope.
  • Excellent organizational, written and verbal communication skills; and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
  • Proficiency working with Microsoft Office Suite Products.
  • Ability to work across global time zones (including EU, APAC).
  • Willingness to work occasional weekends based on study needs.

    • Required Key Attributes:

  • Must be able to work independently with supervision as needed.
  • Proficient at working independently as well as in cross-functional team settings
  • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
  • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.
  • Strong problem-solving skills and a proactive attitude towards exploring new approaches.
  • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.

    • Work Authorization:

  • United States (Required)
  • Background Check
  • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.

    • ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

    Company Overview:

    ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company dedicated to transforming cutting-edge science into next-generation RNA therapeutics to treat a broad spectrum of diseases. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs.

    Disclosure Statement:

  • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
  • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
  • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
  • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
  • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

    • Job Location

    San Diego, California, 92121, United States

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