Sr. Clinical Trial Manager

Shifamed•Los Gatos, CA

About The Position

Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE). The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. Akura Medical is developing NavIQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar. Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology. The Sr. Clinical Trial Manager (Sr. CTM) is a hands-on program owner responsible for the end-to-end execution of assigned clinical studies within a portfolio spanning US IDE pivotal trials, registries, and international (OUS) studies. Reporting to the Sr. Director of Clinical Affairs, the Sr. CTM leads studies from start up through closeout, managing timelines, budgets, sites, vendors, and data quality while leveraging CROs and contract monitors for field execution. This position may be filled at the Clinical Trial Manager or Sr. Clinical Trial Manager level, determined by the successful candidate’s experience and capabilities. This is a program-owner role on a lean, fast-moving clinical team, and calls for someone who moves quickly without compromising quality or compliance.

Requirements

BA/BS in life sciences, engineering, nursing, or a related field; advanced degree (MS, PhD, MD, or RN) preferred.
7+ years managing medical device clinical trials, with hands-on experience across study start-up, monitoring oversight, and closeout.
Class II/III device experience preferred.
Experience selecting and managing CROs, EDC systems, and independent monitors; data management and vendor oversight experience preferred.
Demonstrated experience running FDA IDE studies; experience with registries and/or international (OUS) studies a strong plus.
Strong working knowledge of ICH GCP, ISO 14155, and FDA regulations (21 CFR Parts 11, 50, 54, 56, and 812); familiarity with EU MDR and OUS regulatory pathways (e.g., Brazil ANVISA) a plus.
Startup mindset: comfortable building process, operating with limited supervision (commensurate with level), and navigating ambiguity in a resource-constrained, fast-paced environment.
Excellent project management skills across concurrent studies, timelines, and budgets; PMP certification or proficiency with tools such as Smartsheet or MS Project a plus.
Excellent written and verbal communication skills; comfortable presenting to leadership and cross-functional partners.

Nice To Haves

Advanced degree (MS, PhD, MD, or RN) preferred.
Class II/III device experience preferred.
Data management and vendor oversight experience preferred.
Experience with registries and/or international (OUS) studies a strong plus.
Familiarity with EU MDR and OUS regulatory pathways (e.g., Brazil ANVISA) a plus.
PMP certification or proficiency with tools such as Smartsheet or MS Project a plus.

Responsibilities

Own end-to-end execution of assigned clinical studies (IDE, registry, post-market, and international) from start-up through closeout, delivering each on time, on budget, and inspection-ready.
Lead study start-up activities, including contributions to protocol, informed consent, and case report form development; site identification, qualification, and selection; and IRB/EC and regulatory submissions.
Develop and maintain study documentation, including clinical/investigational plans, monitoring plans, training and recruitment materials, and study reports.
Oversee monitoring performed by CROs and contract CRAs; review monitoring reports, resolve site issues, and conduct sponsor oversight or co-monitoring visits as needed.
Establish and maintain the Trial Master File (TMF), and oversee EDC build, user acceptance testing, and data quality throughout the study lifecycle.
Manage clinical supply forecasting, investigational device accountability, and site payment processes.
Drive enrollment against plan; proactively identify and resolve barriers with sites and internal teams.
Support Clinical Event Committee (CEC) and Data Safety Monitoring Board (DSMB) activities, and contribute to annual reports, safety reports, and study summaries for regulatory submissions.
Build and maintain integrated project plans that define scope, milestones, dependencies, resourcing, and critical path for each assigned study.
Maintain risk registers, tracking tools, and dashboards; surface risks and dependencies early and drive mitigation to closure.
Prepare and deliver clear, executive-ready status updates and metrics to the Sr. Director of Clinical Affairs and cross-functional stakeholders on a regular cadence.
Contribute to the build-out of Clinical Affairs operating mechanisms — templates, SOPs, dashboards, and resource planning — to mature the function as it scales.
Select and manage CROs, core labs, EDC and eTMF providers, independent monitors, and other vendors; hold them accountable to contracted scope, timelines, and quality.
Develop and manage study budgets and forecasts; track expenditures, reconcile invoices, and manage site contracts and budgets.
Identify and mitigate operational, timeline, and budgetary risks across assigned programs.
Ensure all clinical activities comply with ICH GCP, ISO 14155, FDA regulations (21 CFR Parts 11, 50, 54, 56, and 812), and applicable local and international requirements (e.g., ANVISA for Brazil-based studies).
Prepare sites and studies for regulatory inspections and sponsor audits; serve as a primary operational contact for regulatory queries on assigned studies.
Partner with Regulatory, R&D, Quality, Data Management, and Biostatistics to align study execution with program and submission timelines.
Build and maintain strong relationships with investigators, study coordinators, and key opinion leaders; plan and lead investigator and coordinator meetings and site training.
Provide operational guidance to CRAs and study-team members as the team grows, and contribute to continuous improvement of clinical operations processes and best practices.
Independently own the most complex, highest-scrutiny studies (e.g., pivotal IDE trials) with minimal oversight.
Hold decision authority for vendor selection, study budgets, and protocol/design input.
Lead the build-out of Clinical Affairs operating mechanisms, SOPs, and best practices for the function.
Mentor and provide operational guidance to CRAs and more junior study-team members.