--- title: 'Study Start-up and Regulatory Manager at Pedestal Health' canonical: 'https://feeny.ai/job/study-start-up-and-regulatory-manager-pedestal-health-research-triangle-park-bvrc351c41c1' type: 'job' last_seen: '2026-09-14' --- # Study Start-up and Regulatory Manager at Pedestal Health - **Company:** Pedestal Health - **Location:** Research Triangle Park, NC - **Posted:** 2026-08-12 - **Last confirmed live:** 2026-09-14 - **Apply:** https://job-boards.greenhouse.io/pedestalhealth/jobs/5388669008 ## Job description ## About Pedestal Health Pedestal Health (formerly Target RWE) combines deep health system partnerships, longitudinal data curation at scale, and modern study design to build continuous, high-quality evidence for life sciences organizations. The company partners with pharmaceutical and biotech companies, providers and payers to generate rigorous, multimodal evidence that supports clinical, regulatory and strategic decision-making across the full lifecycle of care. Pedestal Health is committed to advancing medical decision making to improve outcomes for patients. Pedestal Health is a Highlander Health company. Learn more at [pedestalhealth.com](http://pedestalhealth.com). ## The Role Pedestal Health is seeking a Study Start-Up and Regulatory Manager to independently lead regulatory and start-up activities across a portfolio of concurrent clinical research projects. This individual will serve as the subject matter expert for IRB/IEC submissions, essential document collection, and Trial Master File (TMF) maintenance, ensuring studies are activated and maintained in full compliance with applicable regulations and audit-readiness standards. ## What You’ll Do - Independently prepare, execute, and manage IRB/IEC submissions, including initial submissions, continuing reviews, and amendments, across multiple concurrent studies. - Lead study start-up and regulatory activities across Phase I–IV investigational (drug/biologic), observational, and medical device submissions. - Establish and maintain audit-ready Trial Master Files (TMFs) in accordance with ICH-GCP, sponsor requirements, and applicable regulatory guidelines. - Coordinate translation of study documents (e.g., informed consent forms and related materials) to support multi-region and multi-language studies. - Collect, review, and track all essential regulatory documents required at study/site start-up (e.g., Form FDA 1572s, CVs, licenses, financial disclosures, IRB/IEC approvals, insurance certificates, and lab certifications). - Proactively track document expiration dates and request updated or renewed documents throughout the life of the study to maintain continuous compliance. - May serve as a liaison between sponsors, CROs, investigative sites, and IRBs/ECs to ensure timely regulatory submissions, approvals, and issue resolution. - Maintain regulatory tracking systems and provide regular status updates to project teams and leadership. - Ensure ongoing compliance with ICH-GCP, FDA regulations, and applicable local and international regulatory requirements. - Support contract and budget negotiations with sites, as needed. ## What You’ll Bring - Bachelor's degree required. - Minimum of 3 years of experience independently performing IRB submissions, essential document collection, and TMF maintenance or applicable experiences. - Demonstrated experience supporting Phase I–IV investigational and observational submissions. Medical device experience is a plus. - Working knowledge of ICH-GCP guidelines, FDA regulations, and IRB/IEC submission requirements. - Strong organizational skills with the ability to independently manage multiple projects and competing priorities. - Excellent written and verbal communication skills. - Ability to work in a hybrid environment based in Research Triangle Park, NC (3 days in office, 2 days remote). ## Nice to Have - Experience with contract and budget negotiation is a plus but not required. - Experience supporting medical device submissions is a plus but not required. ## What We Offer You - Hybrid work arrangement, with regular onsite collaboration at a Pedestal Health office - Comprehensive health, dental, and vision coverage - 401(k) with company match - Generous PTO and paid parental leave If you are ready to be part of a team where your work truly matters—where your expertise is valued, your growth is supported, and your contributions help shape the future of healthcare—Pedestal Health is the place for you. We’re building something meaningful together, and we’d love for you to be a part of it. Pedestal Health is an equal opportunity employer and seeks candidates from diverse backgrounds and abilities. ## About Pedestal Health ## Company Overview - **One-liner**: Pedestal Health is an integrated evidence generation partner for life sciences organizations, building continuous, longitudinal patient cohorts to support drug development, regulatory decisions, and clinical care. - **Entity Type**: Private (Part of Highlander Health, a venture-backed company co-founded by Amy Abernethy and Brad Hirsch) - **Headquarters**: Durham, North Carolina, USA - **Founded**: The company emerged from the rebranding of Target RWE and NoviSci, announced in May 2026. Target RWE was founded earlier; the current entity is the result of that merger. - **Founders**: Co-CEOs: Amy Abernethy, MD, PhD, and Brad Hirsch, MD ## Core Business - **Primary industry/industries**: Healthcare Technology, Real-World Evidence (RWE), Clinical Research, Life Sciences Data & Analytics - **Target customers**: Pharmaceutical and biotech companies, health systems, payers, and regulatory bodies (FDA/EMA). - **Mission or purpose statement**: To build a modern evidence-generation engine that reduces treatment access time by 50% through continuous evidence and personalized care, moving from episodic, start-from-scratch clinical studies to an infrastructure that compounds over time. ## Products & Services - **Longitudinal Real-World Data Cohorts**: Deeply phenotyped, disease-specific patient datasets (e.g., hepatology, dermatology, gastroenterology) built directly from clinical practice, continuously queried for safety, effectiveness, and regulatory studies. - **Regulatory-Grade Evidence Generation**: Full-service design and execution of externally controlled trials, prospective interventional studies, registries, and traditional real-world evidence studies for submission to FDA/EMA/HTA bodies. - **Headwater Science (Sister Company)**: A methodological and analytical engine offering deep expertise in causal inference, comparative effectiveness, healthcare utilization, and regulatory-grade analytical software. This is a separate but closely integrated entity within Highlander Health. ## Market Standing - **Valuation/Market Cap**: Not publicly disclosed. - **Key Metric**: Formed from the merger of two established companies (Target RWE and NoviSci) with strong existing revenue and partnerships; backed by Highlander Health, which is focused on evidence generation innovation. - **Notable Investors/Partners**: Highlander Health (the lead investor and parent company). Key health system partnerships are highlighted (e.g., University of North Carolina). - **Growth Signals**: Rebranding and strategic merger in May 2026 signals significant capital and strategic ambition. The company is actively hiring across multiple roles (engineering, data science, delivery, finance). Leadership includes former FDA Deputy Commissioner (Amy Abernethy) and founder of a successful clinical trial technology company (Brad Hirsch). ## Competitive Advantages - **Continuous Evidence Infrastructure**: Unlike traditional CROs or data providers, Pedestal builds **continuous** cohorts that compound over time, avoiding the "start from scratch" model for every new study. - **Deep Clinical Domanin Expertise**: Deepest footprint in hepatology, dermatology, and gastroenterology with pre-existing, deeply phenotyped patient populations and long-standing health system relationships. - **Regulatory & C-Suite Credibility**: Leadership team with unparalleled experience (former FDA Principal Deputy Commissioner, founders of successful healthcare tech companies, top clinical researchers). This translates into regulatory-grade outputs trusted by agencies. - **Integrated Methodological Engine (Headwater Science)**: Built-in access to world-class causal inference and data science expertise for complex analytical challenges, a significant moat against generalist competitors. - **Health System Embeddedness**: Data is sourced directly from clinical practice, offering a richer, more longitudinal picture of patient journeys than claims data alone. ## Strategic Focus - **Current priorities**: Expanding into new therapeutic areas beyond their core hepatology, dermatology, and GI strongholds. Scaling the "continuous evidence system" model across more biopharma partners. Integrating more deeply with health system IT for seamless data flow. - **Direction for growth**: Becoming the "evidence infrastructure" for the life sciences industry, moving from project-based work to platform-based, recurring partnerships. Focus on solving the most complex, high-stakes regulatory and access questions. ## Why Work Here - **Culture**: The company emphasizes passion, dedication, and use of patient data to shift the healthcare paradigm. They highlight "diverse and innovative perspectives" as core to their cutting-edge approach. - **Remote/Hybrid Policy**: **Hybrid work** is explicitly offered as a benefit. - **Notable Perks & Benefits**: - Competitive Health Insurance - **Paid Parental Leave** - Professional Development Courses - Employee Recognition Programs - Paid Holidays & Floating Holidays - **401(k) with Company Match & Immediate Vesting** - Paid Time Off - **Engineering/Data Science Culture**: At the intersection of clinical research, data science, and regulatory technology. The work directly impacts drug development timelines and patient access. The team includes world-class biostatisticians, epidemiologists, data engineers, and product managers. For those passionate about data for social impact in health, this is a mission-driven, fast-paced environment backed by deep expertise. ## Sources 1. [Pedestal Health Official Website](https://www.pedestalhealth.com/) 2. [About Us / Leadership](https://www.pedestalhealth.com/about/) 3. [Careers Page (Greenhouse)](https://job-boards.greenhouse.io/pedestalhealth) 4. [Pedestal Health Careers / Benefits](https://www.pedestalhealth.com/careers/) 5. [Yahoo Finance: Target RWE and NoviSci Rebrand as Pedestal Health and Headwater Science](https://finance.yahoo.com/sectors/healthcare/articles/target-rwe-novisci-rebrand-pedestal-110000567.html) ## Other roles at Pedestal Health - [Principal Data Scientist](https://feeny.ai/job/principal-data-scientist-pedestal-health-research-triangle-park-zgwh50nmz6gp) — Research Triangle Park, NC - [Senior Clinical Research Associate](https://feeny.ai/job/senior-clinical-research-associate-pedestal-health-research-triangle-park-mms5e1bjft8k) — Research Triangle Park, NC - [Director Data Management](https://feeny.ai/job/director-data-management-pedestal-health-united-states-em1ws5k0pbyt) — United States - [Data Engineer](https://feeny.ai/job/data-engineer-pedestal-health-research-triangle-park-ydmccp5n5c8e) — Research Triangle Park, NC - [Cloud Security Engineer (AWS)](https://feeny.ai/job/cloud-security-engineer-aws-pedestal-health-research-triangle-park-qy1h836f1dex) — Research Triangle Park, NC - [Senior AI/ML Engineer](https://feeny.ai/job/senior-ai-ml-engineer-pedestal-health-united-states-4z1bqhq3njgq) — United States