Jobs at Premier Research

Provides project-related scientific services to biotech, medtech, and specialty pharma clients. Responsibilities include supporting early engagement activities, preparing for business development, participating in selected business development meetings, and developing client portfolios in neuroscience-related indications.

Manages clinical study start-up teams, staffing, resources, timelines, metrics, forecasting, and process improvement across multiple countries. Oversees direct reports through mentoring, training, performance management, and career development. Supports feasibility, costing, proposals, client presentations, regulatory and SOP compliance, stakeholder transitions, and harmonized study start-up processes. Requires clinical research experience, people management, regulatory knowledge, analytical skills, and familiarity with CRO, device, or pharmaceutical environments.

Manages clinical study start-up teams, staffing, resources, timelines, metrics, and process improvements across multiple countries. Oversees direct reports through mentoring, training, performance management, and career development. Supports feasibility, costing, proposals, client presentations, SOPs, regulatory compliance, and study transitions. Establishes harmonized start-up processes while coordinating stakeholders and ensuring adherence to ICH/GCP, FDA, European regulatory, and applicable ethics committee requirements.

Manages global study start-up teams, staffing, resourcing, timelines, budgets, metrics, regulatory compliance, and process improvements. Leads and develops direct reports, coordinates activities across multiple countries, supports feasibility and business development, oversees SOP and training implementation, and maintains communication with clients and internal stakeholders. Ensures study start-up, maintenance, and closeout processes are harmonized, efficient, and compliant with applicable clinical research regulations.

Supports clinical research project delivery by coordinating cross-functional teams, scheduling meetings, maintaining documentation and project systems, tracking budgets, supplies, invoices, vendors, change orders, and audit readiness. Assists Project Managers with communications, contact lists, action logs, newsletters, SOP indices, system access, and distribution lists. Requires clinical research or related professional experience and knowledge of clinical research regulations, project management, and Microsoft Office.

Supports clinical research project delivery by coordinating cross-functional teams, meetings, communications, documentation, budgets, vendor invoices, supplies, change orders, project systems, SOP indices, access requests, and audit readiness. Partners with Project Managers to maintain project controls and ensure effective internal and external collaboration across biotech, medtech, and specialty pharma studies.

Leads the European Study Start Up function, overseeing teams responsible for essential document collection, ethics and regulatory submissions, site initiation, timelines, staffing, performance, and risk management. Partners with project management, clinical leadership, business development, and global SSU teams to deliver studies according to contracts. Drives process improvements, training, metric reporting, resource planning, client relationships, and staff development while ensuring compliance with ICH/GCP, ISO 14155, and country-specific clinical trial requirements.

Supports clinical research project delivery by coordinating cross-functional teams, scheduling meetings, maintaining documentation and contact lists, tracking budgets, supplies, invoices, vendors, and change orders, and ensuring projects remain audit ready. Manages project systems, SOP indices, study team lists, access requests, and communications. Requires clinical research or related professional experience, knowledge of ICH/GCP and relevant FDA, EU, and ISO 14155 requirements, project management fundamentals, and strong Microsoft Office skills.

Provides HR administrative support across multiple countries, including employee data maintenance, audits, onboarding, employment contracts, offboarding, benefits administration, employee inquiries, documentation, and exit interviews. Maintains People Operations procedures and supports HR projects while ensuring data accuracy, compliance, and timely service delivery.

Manages site contract activities for clinical studies, including NDAs, clinical trial agreements, amendments, negotiations, templates, compliance, risk mitigation, timelines, and sponsor communications. Advises on regulatory and clinical operations procedures while ensuring contracts align with local legal, privacy, ICH/GCP, FDA, EU, and ISO 14155 requirements.

Leads site contract activities for clinical studies, including NDAs, clinical trial agreements, amendments, negotiations, templates, compliance, risk mitigation, and study timelines. Serves as liaison among sponsors and country experts, represents contracts during kickoff meetings, and advises on regulatory and clinical operations procedures. Requires clinical research contracts experience, legal or life sciences education, contract and privacy law knowledge, and familiarity with ICH/GCP, FDA, EU, local, and ISO 14155 requirements.

Manage site contract activities for clinical studies, including NDAs, clinical trial agreements, amendments, negotiations, templates, compliance, timelines, and risk mitigation. Liaise with sponsors and country experts, support regulatory and clinical operations procedures, and represent the contracts function in sponsor meetings. The role requires legal or life sciences education, extensive clinical research contract leadership, and knowledge of privacy, ICH/GCP, FDA, EU, local, and ISO 14155 regulations.

Manage site contracts for clinical studies, including NDAs, clinical trial agreements, amendments, negotiations, templates, compliance, budgets, risks, and timelines. Liaise with sponsors and country experts, represent Contracts during study meetings, and advise on regulatory and clinical operations procedures. The role requires substantial clinical research contract leadership, legal or life sciences education, knowledge of privacy and cross-border data regulations, ICH/GCP, FDA, EU, local regulations, and ISO 14155.

Supports clinical trial site start-up activities by forecasting submission timelines, preparing regulatory and ethics applications, collecting essential documents, resolving country-level issues, negotiating site contracts and budgets, and reviewing informed consent and patient documents. Ensures compliance with local regulations, FDA and EU requirements, ISO 14155, and ICH/GCP guidelines while coordinating with project, clinical, and regulatory teams.

Lead clinical data science activities across studies: coordinate internal/external teams and vendors; drive clinical database development (eCRF, edit checks, UAT); assess and mitigate data risks; ensure documentation, eTMF filing, audits, budgets, metrics, and SOP compliance; support/implement automation and AI solutions to improve data quality and efficiency.

Leads and oversees moderate-to-large, multi-region clinical trials from initiation through completion. Coordinates cross-functional teams, manages timelines, budgets, scope, resources, compliance, reporting, stakeholder communications, and project deliverables to ensure on-time, high-quality, profitable results.

Manages global clinical research projects from planning through completion, coordinating Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety teams. Oversees project scope, budgets, resources, milestones, compliance, deliverables, and internal and external status reporting. Requires experience managing studies, project-level costing, global projects, and multiple therapeutic areas and protocols.

Manages study start-up teams, staffing, resources, timelines, metrics, and process improvement in a global clinical research environment. Oversees direct reports, forecasting, training, SOP compliance, regulatory guidance, client presentations, feasibility analysis, costing, and stakeholder transitions. Establishes harmonized start-up processes and supports business development while coordinating activities across multiple countries.

Develops, validates, and supports R Shiny applications and reusable programming utilities for clinical trial review, data visualization, statistical reporting, quality control, and regulatory submissions. Uses R, SAS, and Python while collaborating with biostatisticians, statistical programmers, data management, clinical operations, and IT. Ensures solutions meet GxP, Computer Software Assurance, testing, scalability, performance, and company standards.

Manages clinical trial data activities, including database development, eCRF planning, edit checks, external data coordination, user acceptance testing, risk assessment, documentation, eTMF filing, quality control, metrics, budgets, and study team communications. Supports multiple projects while ensuring compliance with SOPs, timelines, data standards, and study requirements.