Astute Medical, Inc.
3550 General Atomics Ct, Building 2, San Diego, CA 92121
Clinical Trial Manager
General Job Description:
Reporting to the Vice President Clinical & Regulatory Strategy, this position will be responsible for leading and managing the operational activities for clinical studies to support planning, initiation, conduct and close out of Astute Medical, Inc.’s clinical trials. This position will ensure clinical study activities are conducted in compliance with FDA regulations, ICH guidelines, and are in adherence with corporate and departmental Standard Operating Procedures. The Clinical Trial Manager will be an active member and team player of Astute’s new products’ Design and Development team. This individual will have multiple responsibilities for managing and monitoring the day-to-day logistics of clinical trials (i.e. tasks, timelines, budgets, and internal and external resources), including partnering with clinical research organizations and clinical sites to achieve program objectives in a timely fashion. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the Vice President of Clinical & Regulatory Strategy, when needed.
Responsible for all operational aspects and progress of clinical trials from study planning activities to study execution including ongoing tracking all applicable performance metrics and quality indicators.
Provide operational and strategic input and/or approve study documents such as synopses, protocols, ICFs, CRFs, CRF Completion Guidelines, Study Plans, Clinical Study Report (CSR) development, etc.
Ensure trial activities are compliant with applicable regulations and guidelines, including FDA and ICH GCP guidelines, and internal and external SOPs.
Responsible for site and study management, including TMF set-up, essential document collection and retention, budget and contract negotiations, study material preparation, enrollment tracking, report review monitoring and approval, and final reconciliation of study documents.
Create, manage, measure, and report timelines for milestone deliverables.
Serve as clinical lead on Design Control teams for new product development. Prepare and review Design Control documentation related to clinical validation. Responsible for ensuring all clinical DHF documentation is present, compliant and maintained.
Contribute to protocol design by providing input on operational logistics/feasibility, and writing/reviewing various sections.
Responsible for and participates in clinical vendor selection process as a part of outsourcing activities (e.g., CROs). Provide oversight for vendor operational activities (e.g., study management, monitoring, specifications development, UATs, invoices).
Collaborate with legal counsel to negotiate and draft research contracts and agreements with CRO's/vendors and clinical study sites, as needed.
Assist in identification and selection of clinical investigators and study sites.
Interact with and/or direct, internal and external personnel, including physicians, monitors, administrative personnel, regulators, and consultants.
Develop, oversee and own subject recruitment/retention strategy.
Serve as an escalation point and resource for study team and investigational sites.
Recruit, manage, and train contract CRAs as needed.
Prepare project plan/timelines and monitors against project progress; ensures project activity compliance with plan. Suggests and implements alternative solutions to problems with study timelines, schedules, resources, budgets, etc. Takes corrective action where necessary.
Refine Quality Management System clinical procedures and processes based on knowledge of regulations and business needs. Assess quality management system for impact of new standards/regulations (e.g., IVDR, GDPR) and market expansion, as related to Clinical Trial Management.
Responsible for ensuring compliance with applicable Astute Medical policies and procedures across the organization.
Performs other duties & projects as assigned
BS/BA degree (or higher) in science or technical discipline (RN or BSN degree included) or equivalent.
Demonstrated experience leading clinical studies for IVD FDA 510k submission and CE declaration for new system launch preferred. Experience managing a CRO is preferable.
At least 5 - 7 years relevant clinical research experience in biotech/IVD company or clinical research organization (CRO) or equivalent. Preference given to candidates with in vitro diagnostic product development and prior small company experience as well as those with and 1+ years management experience.
In-depth knowledge of and demonstrated experience with clinical research operations, including interpretation and implementation of FDA regulations and ICH/GCP guidelines.
Ability to work independently, exercise sound judgment, manage diverse and conflicting priorities and projects in an effective manner, and meet deadlines.
Strong communication skills (verbal & written) including ability to interact positively with all levels of the organization.
Ability to work cohesively with multi-disciplinary scientific working groups.
Sense of urgency to deliver or surpass study milestones.
Proficient with Microsoft Office suite.
Willing and able to travel if needed (~20-25%).
Application Information & Contact (How to Apply)
Please apply through their career page here.
Learn more about Astute Medical here.