Jobs at Premier Research

Leads country-level clinical trial site start-up activities, including regulatory, ethics committee, and IRB submissions; forecasts approval timelines; resolves submission issues; manages essential document compliance; and supports investigator contract and budget negotiations. The role requires experience across clinical trial types, knowledge of FDA, EU, local regulations, ISO 14155, and ICH/GCP guidelines, plus leadership of larger start-up programs.

Supports clinical trial data management by reviewing database and external listing data, creating and resolving queries, maintaining clean databases, and updating data management documentation. Assists with Data Management Plans, case report form development, edit check specifications, data listing testing, and user acceptance testing. Requires collaboration with clinical sites, vendors, CRAs, and clients while managing multiple projects and changing priorities in a remote environment.

Leads the innovation and technology roadmap for statistical programming in pharmaceutical and CRO environments. Evaluates AI tools, modernizes SAS workflows with R and Python, develops reusable packages and automated pipelines, and provides technical direction for R Shiny applications. Establishes architecture and deployment standards, while supervising, mentoring, and developing statistical programming staff.

Support clinical data management activities for clinical trials: review and clean databases, generate and resolve queries, assist CRF and edit-check development, perform user acceptance testing, and maintain testing documentation per protocol and Data Management Plan.

Execute and document software testing and validation activities per test plans in a regulated (FDA) environment. Perform unit testing, assemble validation deliverables, apply test methodology, and support compliance-driven software validation efforts while collaborating with the Clinical Technologies team.

Builds and tests clinical databases and eCRFs for EDC and paper studies. Programs edit checks, derivations, validations, and reporting transforms. Collaborates with data and study management teams during study startup to meet specifications and deliver quality outputs.

Prepare and submit central and local EC/IRB, regulatory and hospital approvals; manage amendments and safety notifications; collect and QC essential documents; negotiate local investigator contracts and budgets; conduct country-level site feasibility; prepare IP checklists and ensure TMF completeness throughout study start-up.

Design, develop, and support enterprise AI solutions: lead AI solution design, build prompts/workflows, implement RAG, integrate AI platforms with corporate applications, deploy/manage AI services on Azure, administer Azure AI Foundry, troubleshoot tickets to SLA, and lead platform upgrades and documentation.

Lead and coordinate global project teams across Regulatory, Clinical Ops, Biometrics, and Medical Affairs to deliver neuroscience trials on scope, schedule, and budget. Serve as primary client liaison, ensure compliance with Premier Research processes, support business development and proposals, and develop client relationships. Manage complex, multi-phase, full-lifecycle trials with therapeutic expertise in psychedelics, MDD, and epilepsy.

Lead global cross-functional teams to deliver neuroscience clinical projects, managing budgets, scope, timelines, compliance, and client relationships. Coordinate Regulatory, Clinical Ops, Biometrics, and Medical Affairs/Safety, chair meetings, support proposals and business development, and manage complex multi-phase trials across psychedelics, MDD, and epilepsy.

Lead and coordinate global neuroscience project teams across Regulatory, Clinical Operations, Biometrics, and Medical Affairs to deliver complex clinical trials on scope, schedule, and budget. Serve as primary client liaison, chair meetings, ensure compliance with Premier Research processes, support proposal development and business development, and cultivate client relationships to generate future business.

Lead cross-functional global project teams for neuroscience studies, manage budgets and scope, ensure compliance with processes, liaise with clients, support business development and proposal activities, and cultivate client relationships for add-on business.

Lead and coordinate global cross-functional project teams for neuroscience clinical programs, manage budgets and scope, ensure compliance with Premier Research processes, serve as primary client liaison, support business development and client relationship growth, and oversee complex, multi-phase clinical trial delivery.

Lead global, cross-functional project teams for neuroscience clinical programs. Manage budgets, scope, compliance, milestones, client relationships, and business development while overseeing complex, multi-phase trials across psychedelics, MDD, and epilepsy.

Lead global neuroscience project teams (Regulatory, Clinical Ops, Biometrics, Medical Affairs) to deliver complex, multi‑phase trials. Manage project budgets, scope, schedules, and compliance; act as primary client liaison; chair project meetings; support business development and proposals; build client relationships to generate new/add‑on business. Requires protocol expertise in psychedelics, MDD, and epilepsy.

Manage the lifecycle of clinical trial change order budgets: coordinate stakeholders, develop and analyze budgets using spreadsheets, present budgets to customers, resolve issues, and ensure accurate final change order budgets aligned with CRO processes.

Manage the budget development lifecycle for clinical study change orders, collaborating with BD, Finance, Contracts, and Project Managers to prepare, analyze, and present accurate change order budgets and resolve issues to meet timelines.

Manage the full lifecycle of clinical trial change order budgets: collaborate with BD, Finance, Contracts, and Project Managers; coordinate contributors and timelines; prepare resource/service fees using spreadsheets and algorithms; analyze costs, resolve issues, and present budgets to customers as needed.

Conduct onsite and remote monitoring visits per ICH GCP/ISO14155 and protocol to ensure data integrity, patient safety, TMF maintenance, IP accountability, query resolution, site communication, and project support. Manage administrative duties, mentor CRAs, assess feasibility/recruitment, and meet travel and regulatory requirements.

Lead cross-functional global project teams for dermatology clinical programs, ensuring milestone delivery, budget and scope adherence, compliance with processes, client liaison and meeting leadership, support proposal/business development, and cultivate client relationships to drive future business.