Sr. Clinical Trial Manager

ADARx Pharmaceuticals Inc.•San Diego, CA

7h•$125,000 - $160,000•Onsite

About The Position

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.

Requirements

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.
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.
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.

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.