Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the commercialization of its novel biomarker products, Astute Medical is seeking an energetic, experienced, and self-motivated individual for the position of Clinical Trial Manager (CTM).
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 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).
- 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). 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 (~10-20%).
While performing the duties the employee is:
- Constantly required to reach computers and other office and laboratory equipment
- Constantly required to view objects at close and distant ranges
- Frequently required to communicate with others
- Frequently required to sit
- Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
- May occasionally be required to travel to meetings and audits
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Workweeks exceeding 40 hours are required as necessary.