What are the responsibilities and job description for the Senior Clinical Trial Manager position at BioTalent?
We’re hiring a Senior Clinical Trials Manager to own the full lifecycle execution of clinical studies, including regulatory trials. This is a hands-on, highly operational role for someone who knows how to stand up studies from the ground up and drive them to completion.
You’ll lead clinical execution from protocol development through final study report and act as the primary link between internal teams and external sites, investigators, IRBs, CROs, and vendors. This role plays a key part in generating high-quality clinical evidence that supports regulatory submissions.
What You’ll Do
- Own clinical study execution from feasibility through close-out
- Lead site selection, activation, enrollment, monitoring, and overall study management
- Author and manage protocols, IRB/Ethics submissions, informed consent forms, and essential documents
- Serve as the primary point of contact for clinical sites and investigators
- Oversee clinical data operations, including CRFs/eCRFs, data review, query resolution, and database lock
- Manage study timelines, budgets, vendors, and CRO performance
- Communicate directly with sites (and subjects when needed) to resolve issues quickly
- Ensure compliance with FDA regulations, ICH-GCP, ISO 14155, and applicable medical device or SaMD guidance
- Partner cross-functionally with regulatory, product, engineering, data, and legal teams
- Build and scale clinical operations processes, SOPs, and infrastructure
What You Bring
- 5 years of hands-on clinical operations experience running trials for FDA-regulated medical devices, digital health, or SaMD
- Proven experience managing external clinical sites and CROs
- Strong background authoring clinical protocols, IRB submissions, and ICFs
- Solid understanding of clinical data management and study reporting
- Deep familiarity with FDA device pathways such as IDE, De Novo, and 510(k)
- Experience owning budgets, timelines, and vendor relationships
- Clear, confident communicator who is comfortable presenting to leadership
- Bachelor’s degree required; advanced degree preferred
- ACRP or SOCRA certification is a plus
Nice to Have
- Experience with connected devices, biosensors, or consumer health technology
- Exposure to real-world evidence or decentralized and hybrid trials
- Background in a startup or high-growth environment
- Experience supporting FDA pre-submissions or breakthrough programs