Clinical Trial Manager

ADARx Pharmaceuticals Inc.•San Diego, CA

6d•Onsite

About The Position

We are seeking a highly motivated and qualified individual to join our Clinical Department as a Clinical Trial Manager (CTM) and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The CTM will support ongoing RNA-based drug discovery projects in several therapeutic areas. The Clinical Trial Manager (CTM) 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.
6+ years of combined managing/monitoring Phase 1-3 clinical trials.
Ability to work across global time zones (including EU, APAC).
Experience in performing clinical site monitoring visits, including remote visits.
Experience in CRO/Vendor management (domestic/international)
Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements.
Proficiency working with Microsoft Office Suite Products, EDC, IRT.
Ability to travel domestically and internationally if necessary.
Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
Strong problem-solving skills and a proactive attitude towards exploring new approaches.
Excellent written and verbal communication skills are essential for this role.
Must be able to work independently with supervision as needed.
Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
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.
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.

Nice To Haves

Global clinical trial experience preferred.
Small to mid biotech experience preferred.

Responsibilities

Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives.
Management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines.
Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, independent contractors) to execute clinical trials.
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.
May perform clinical data review of patient profiles, data listings and summary tables, including query generation.
Develop and/or provide input to trial plans, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Study Guides/Manuals, Protocol Deviation Plan, etc.
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.
Reviewing monitoring reports and other study documentation as required.
Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
Participation in team meetings and collaborate with other functional groups within the company and project team (e.g., Medical, Data Management, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.
Following up on assigned team action items and identification, escalation, and resolution of issues as needed.
Collaboration with contracts specialist/Legal to review and negotiate Clinical Trial Agreements and site specific study budgets.
Assessment of adequacy/feasibility of potential clinical investigators and sites including evaluating facilities, personnel, patient referral base, and adherence to GCP.
Conduct site visits (e.g., training visits, site initiation visits, monitoring visits), as required.
Managing investigational product accountability and reconciliation process.
Assist with the preparation of safety, interim and final clinical study reports, and resolution of data discrepancies.
Providing clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies.
Serving as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies.
Review protocol deviations and data listings.
Support safety reporting.
Support the management, tracking and oversight of clinical site budgets/payments in relation to conduct of a clinical trial.
Manage IRB/IEC and regulatory submissions, as needed.
Establish vendor management plans and review quality metrics.
Maintain all appropriate corporate standards for facility safety.
Other duties as assigned.