Lynd Clinical is building a fully owned and operated clinical research network purpose-built for rural and community America. We partner with leading U.S. health systems and regional providers to bring clinical trials directly into the settings where patients already receive care.

Our model combines owned site infrastructure with a proprietary AI platform that analyzes longitudinal medical records to identify, screen, and enroll high-quality participants with speed and precision: driving faster enrollment and better trial outcomes for both sponsors and trial participants.

The Role

The Senior Manager, Study Start-Up and Quality leads the strategic planning, negotiation, and execution of site activation activities, including site training, essential document collection, regulatory submissions, and Site Initiation Visit requirements. They ensure rapid, compliant trial initiation across trial programs by delivering on timelines and processes and overseeing and meeting expected key performance indicator (KPI) metrics. In addition, the Senior Manager, Study Start-Up and Quality has oversight of the site quality assurance processes ensuring overall site compliance with regulatory requirements, which includes overseeing all site quality trends, conducting onsite and remote quality audits, and assisting with any regulatory or Sponsor/CRO audits.

Responsibilities

• Start-Up Activities: Leads and coordinates study start-up activities across internal teams and external stakeholders under the direction of VP, Regulatory and Strategy. Follow standard processes for the collection and processing of study site start-up documents and site start-up information.
• KPI Performance: Completes expected start-up and regulatory strategies to ensure high-quality site activation, reducing timelines from site selection to first patient in (FPI).
• Regulatory Activities: Ensures compliance with IRB/EC and Health Authority requirements. Prepares and submits IRB/EC Applications and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications as required; includes safety notifications as required by local rules.
• Quality Assurance: Oversees trending of quality control checks, conducts onsite and remote internal audits on a regular cadence ensuring all reporting, equipment, site training, and documentation are in compliance with ICH GCP and FDA guidance. Develops and manages site CAPAs, assists with Sponsor/CRO and FDA audits as required, recommends resolutions for any internal or external quality findings, and manages continuous site compliance and improvement.
• Team Management: Leads, coaches, and mentors regulatory and quality teams, conducting performance management and ensuring functional expertise development, as required.
• Stakeholder Collaboration: Acts as a liaison between clinical operations, legal, finance, and site teams to ensure ongoing site readiness and compliance. Execute deliverables for assigned protocols within Sponsor timelines by identifying clinical team needs, managing vendor supported tasks, and tracking critical timelines.

What We’re Looking For

- 6+ years of direct experience in regulatory, study start-up, clinical operations, and project management/site management within a clinical site environment, CRO or pharmaceutical company. Direct site experience is required.

- Experience with electronic Trial Master File (eTMF), BOX, and electronic Investigator Site File (eISF) platforms and processes.

- Deep knowledge of regulatory and quality processes, including site activation. In-depth understanding of ICH GCP guidelines and FDA regulations.

- Proven ability to drive site performance and quality. Strong strategic thinking and communication skills.

- Bachelor’s degree required.