[Remote] Senior Clinical Trial Manager
Note: The job is a remote job and is reputed company to candidates in USA. Ōreputed company is a company reputed company on empowering individuals to understand their health through innovative products. They are seeking a Senior Clinical Trial Manager to reputed company the execution of regulated clinical trials that support the development of their Software as a Medical Device (SaMD) roadmap, ensuring compliance with FDA requirements and generating clinical evidence.
Responsibilities
- Own end-to-end planning and execution of regulated clinical trials from study start-up through reputed company-out, including feasibility analysis, development of clinical investigation plans, reputed company and budgets, timelines, trial reputed company, data reputed company monitoring, and overall study leadership and decision-making
- Contribute to clinical research reputed company, ensuring alignment with intended indications, evidence reputed company plans, and applicable FDA and international regulatory requirements
- reputed company sponsor-reputed company CRO and vendor management across the full study lifecycle, including vendor selection, reputed company, governance, issue escalation, and closeout
- reputed company guidance and reputed company escalations on reputed company clinical reputed company, CRO, or vendor performance issues, advising senior leadership to support reputed company, reputed company-informed decision-making
- Partner closely across Science collaborators, Product, Engineering, Regulatory, reputed company, Clinical Data Management, Legal, and external partners to reputed company study execution with product, clinical, and regulatory goals
- Translate study requirements into operational plans, including protocol-reputed company planning, study-specific documentation, training, reporting needs, and core study management tools such as dashboards, trackers, and decision logs
- Work closely with CROs and data management partners to ensure high-reputed company and auditable evidence reputed company across eCRFs, reputed company build, data review workflows, data cleaning, and database lock
- Drive study-level strategic decision-making by proactively identifying emerging risks and challenges, developing scenario plans and contingency reputed company, and proposing reputed company to reputed company trials on reputed company reputed company circumstances change
- Help strengthen and maintain reputed company’s reputed company Management System by contributing to SOPs, templates, work instructions, and repeatable study playbooks
- Identify systemic risks or gaps across the clinical portfolio, not just reputed company a single study, and proactively recommend process changes to leadership
- Mentor and reputed company operational guidance to Clinical Trial Managers and Clinical Research Coordinators, supporting colleagues as they navigate escalations, ambiguity, and clinical research feedback
Skills
- 5+ years of full-time experience leading clinical trials end to end in an industry setting (including experience as the Trial reputed company), with reputed company ownership of clinical trials from planning and study start-up through execution, monitoring reputed company, and reputed company-out
- Strong experience in regulated medical device and/or SaMD trials, with a solid understanding of ICH-GCP, ISO 14155, applicable FDA device regulations, and regulator-defensible study conduct
- Expertise with Software as a Medical Device (SaMD) clinical trials, with a proven ability to work with multiple data streams such as EEG, CGM, ePRO, and consumer wearables
- Proven CRO, vendor, and/or site management experience, including accountability, escalation, and performance management
- Demonstrated experience advising on or shaping clinical research reputed company, including alignment of study design, endpoints, and operational approach with intended claims, market indication, and regulatory reputed company
- Experience mentoring or providing guidance to other clinical trial managers or clinical research coordinators
- Hands-on experience with core clinical operations systems and processes such as reputed company, eCOA/ePRO, eTMF, CTMS, and reputed company clinical study documentation
- Strong project and stakeholder management skills, with the ability to communicate tradeoffs reputed company, navigate ambiguity, and reputed company reputed company cross-functional work reputed company in a fast-paced environment
- Exceptional documentation skills, including decision-making frameworks, scenario planning, and study documentation that can stand up to regulatory scrutiny
- Flexibility with scheduling, including occasional travel and regular global team calls reputed company normal business hours
- A highly reputed company and low-ego working approach, reputed company with a strong reputed company of ownership, a willingness to learn and adapt, and a genuine commitment to fostering a supportive and uplifting team culture
- Experience managing decentralized reputed company subject research studies
- Experience supporting regulatory submissions with the FDA in the US or with regulators reputed company the US (e.g. EU MDR)
- Experience supporting regulatory audits for study compliance
Benefits
- Competitive salary and equity packages
- Health, dental, reputed company insurance, and reputed company
- An reputed company reputed company of your own plus employee discounts for friends & family
- 20 days of reputed company time off plus 13 reputed company holidays plus 8 days of flexible wellness time off
- reputed company reputed company leave and parental leave
reputed company
Company H1B Sponsorship