The Clinical Lead II manages clinical delivery strategies, site start-up activities, and patient recruitment and retention. They collaborate with project managers and sponsors to ensure study milestones are met and budgets are aligned with execution.
Premier Research
39 Remote Job Openings at Premier Research
The Clinical Lead II manages clinical delivery strategies, site start-up activities, and patient recruitment targets. They collaborate with project managers and sponsors to ensure study milestones are met and budgets are aligned with execution.
The Clinical Lead II manages clinical delivery strategies, site start-up activities, and patient recruitment targets. They collaborate with project managers and sponsors to ensure study milestones are met and budgets are aligned with execution.
The Clinical Lead II manages clinical delivery strategies, site start-up activities, and patient recruitment targets. They collaborate with project managers and sponsors to ensure study milestones are met and budgets are aligned with execution.
Clinical Trial Associate III, Sponsor-dedicated (contract)
Premier Research
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Full Time
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6 hours ago
Premier Research
The role involves managing eTMF filing, administration, and document review to ensure completeness and inspection readiness. Additionally, the CTA creates tracking tools for KPIs and supports project team meetings and regulatory audits.
The Associate Analyst coordinates clinical study start-up activities, including the collection of essential documents and the creation of feasibility questionnaires. They track site performance metrics and support line managers in ensuring site compliance and readiness for monitoring visits.
Develop SAS programs to generate listings, tables, and figures, and create CDISC analysis data sets. Act as a Lead Biostatistical Programmer to collaborate with study teams and validate general SAS macros.
CRA II, Onc/Neuro/Rare/Derm (West Coast, Midwest, Northeast)
Premier Research
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Full Time
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a day ago
Premier Research
Conduct various types of monitoring visits to ensure data integrity, patient safety, and compliance with clinical monitoring plans. Manage communication between study sites and project teams while maintaining the Trial Master File.
Manage finance system support tickets and provide training on system processes and functionality. Support the administration and configuration of Workday and OneStream to improve operational efficiency and reporting accuracy.
Organize and host vendor audits to support global operations, including the preparation of audit plans, checklists, and reports. Manage the approved vendor list and collaborate with operational teams to resolve systemic issues and implement corrective actions.
Design, develop, and support enterprise-grade AI solutions and integrations across the company's technology ecosystem. Provide technical leadership in orchestrating AI platforms and managing custom MCP servers and agent UIs.
Manage the implementation and negotiation of Non-Disclosure Agreements, Clinical Trial Agreements, and contract amendments. Liaise with clients to report on document execution status and maintain contract templates.
In-House Clinical Research Associate I, Sponsor-Dedicated (Contract)
Premier Research
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Full Time
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14 days ago
Premier Research
The role involves performing remote monitoring of clinical trials and supporting cross-functional teams and study sites. Key duties include reporting SAEs, addressing non-compliance issues, and assisting with audit readiness and study start-up activities.
Senior Clinical Research Associate, Sponsor-dedicated (Contract)
Premier Research
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Full Time
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14 days ago
Premier Research
Conduct source verification and monitor clinical research sites to ensure data accuracy and regulatory compliance. Manage study contracts, perform budget negotiations with sites, and resolve data discrepancies.
Conduct and supervise decentralized clinical research trials for infant formula growth monitoring in England. Maintain medical and regulatory accountability while ensuring participant safety and data integrity through telehealth.
Senior Site Start up Associate / Senior Clinical Research Associate
Premier Research
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Full Time
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16 days ago
Premier Research
The role involves managing site start-up activities, including regulatory submissions to EC/IRB and RA, and negotiating site contracts and budgets. Additionally, the associate performs clinical monitoring to ensure data integrity and patient safety in accordance with local and international regulations.
Manage technical projects and collaborate with cross-functional teams to ensure milestone achievement and overall delivery. Maintain project timelines, monitor progress, and act as the primary point of contact for customers.
Manage and coordinate global project teams across Regulatory, Clinical Operations, and Medical Affairs to ensure milestone achievement and project delivery. Act as the primary liaison for customers while managing project budgets, scope, and business development activities.
Lead the biostatistics team by providing strategic oversight, managing project progress, and ensuring operational efficiency across departments. Act as a primary consultant for sponsors on statistical issues and support business development through bid defenses and RFP strategies.
Lead the biostatistics team by providing strategic oversight, managing client relationships, and ensuring the quality of statistical analysis plans. Coordinate between departments to improve productivity and support business development through bid defenses and sponsor consultancy.
Lead the biostatistics group by managing operational aspects, staffing, and strategic initiatives to support biotech and pharma clients. Provide expert consultancy on statistical issues, oversee project financial health, and collaborate with other departments to improve productivity and quality.
Lead the biostatistics team by providing strategic oversight, managing project financial health, and consulting for sponsors on statistical issues. Coordinate between departments to improve productivity and support business development through bid defenses and RFP strategies.
Lead the biostatistics team by providing strategic oversight, managing client relationships, and ensuring the quality of statistical analysis plans. Coordinate operations between departments to improve productivity and support business development through bid defenses and sponsor consultancy.
Manage and coordinate global project teams across Regulatory, Clinical Operations, and Medical Affairs to ensure milestone achievement and project delivery. Act as the primary liaison for customers while managing project budgets, scope, and business development activities.
Senior Infrastructure and Operations Engineer I
Premier Research
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Full Time
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a month ago
Premier Research
The role involves designing, implementing, and maintaining global IT infrastructure, including servers, networks, and storage. It also requires ensuring regulatory compliance (21 CFR Part 11) and leading troubleshooting efforts for system performance issues.
Regulatory Strategy, Vice President (Bay Area, Boston)
Premier Research
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Full Time
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a month ago
Premier Research
Lead the development and implementation of regulatory strategies for biotech and pharma clients to ensure successful marketing authorizations. Supervise and mentor regulatory staff while managing client budgets and maintaining relationships with health authorities like the FDA and EMA.
Manage and coordinate global project teams across Regulatory, Clinical Operations, and Medical Affairs to ensure milestone achievement and project delivery. Act as the primary liaison for customers while managing project budgets, scope, and business development activities.
The Clinical Lead II oversees site management, monitoring quality, and clinical deliverables for oncology trials. They serve as the primary contact for site performance improvement and ensure audit readiness for both the company and sites.
Executive Director, Program Strategy (Oncology)
Premier Research
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Full Time
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a month ago
Premier Research
Lead the design and strategy of new business opportunities and RFPs for oncology programs. Drive improvement in win rates and customer satisfaction through consultative services and operational planning.
The role involves conducting various monitoring visits at investigator sites to ensure data integrity and patient safety. Responsibilities include delivering quality monitoring reports and maintaining the Trial Master File in accordance with ICH/GCP guidelines.
The Clinical Lead II oversees clinical delivery strategies, site activation, and patient recruitment while managing monitoring quality and compliance. They serve as the primary expert for protocol execution and coordinate between sponsors, CRAs, and site management.
Manage and coordinate global project teams across regulatory, clinical operations, and medical affairs to ensure milestone achievement and project delivery. Act as the primary liaison for customers while managing project budgets, scope, and business development activities.
Regulatory Strategy, Director (Bay Area, Boston)
Premier Research
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Full Time
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2 months ago
Premier Research
Develop and execute regulatory program strategies and lead US and ex-US regulatory teams for biotech and pharma projects. Act as the primary interface with the FDA, EMA, and other national agencies to ensure successful submission and approval of medical products.
Senior Medical Director III (Dermatology)
Premier Research
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Full Time
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2 months ago
Premier Research
Provide comprehensive medical and safety monitoring for dermatology projects while developing clinical development strategies and protocol designs. Offer strategic scientific guidance to project teams and support business development through expert input on RFPs.
Manage the submission of regulatory applications to EC/IRB and local authorities to facilitate clinical trial start-up. Coordinate site identification, contract and budget negotiations, and ensure the accuracy of Trial Master File documentation.
The Senior Project Manager oversees global project teams, including clinical operations and biometrics, to ensure milestone achievement and project delivery. They also act as the primary client liaison and support business development activities through proposal creation and relationship management.
Serve as the lead statistician on complex clinical studies, overseeing statistical strategy from protocol planning to regulatory reporting. Act as a primary point of contact for sponsors while managing project budgets, timelines, and cross-functional team communication.
Serve as the lead statistician on complex clinical studies, overseeing statistical strategy from protocol planning through to final reporting. Communicate quantitative concepts to diverse stakeholders and provide senior oversight for statistical deliverables and innovative trial designs.
The Director will serve as the lead statistician on complex client studies, managing statistical strategy from protocol planning through reporting and ensuring cohesive communication with sponsors and internal teams. They will also develop innovative trial designs, provide senior oversight for statistical deliverables, and advise clients on regulatory guidelines for submissions.