The role involves preparing and submitting regulatory applications to EC/IRB and RA authorities while managing site start-up activities. It also includes negotiating site contracts and budgets and ensuring compliance with ICH/GCP guidelines.
Premier Research
22 Remote Job Openings at Premier Research
The role involves managing the end-to-end site start-up process, including preparing and submitting regulatory applications to EC/IRB and RA authorities. It also entails negotiating site contracts and budgets while ensuring all essential documents comply with ICH/GCP and local regulations.
Manage the full lifecycle of clinical site payment administration, from protocol scheduling and database build to execution. Ensure accurate mapping of EDC data to budget constructs and support audit activities related to investigator payments.
Regulatory Strategy, Director (Bay Area, Boston)
Premier Research
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Full Time
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6 days 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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7 days 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.
Execute software testing according to plans and schedules while applying software test methodologies. Assemble validation output and data in compliance with government regulations and perform unit testing on identified modules.
Oversee and standardize RBQM monitoring and risk review strategies at a program or portfolio level. Lead the development of risk assessment tools and custom monitoring strategies while collaborating with sponsors and internal teams.
The specialist populates the Metadata Repository and creates CRF specifications and annotations based on impact assessments. They also manage the standards workflow change control process and act as a liaison with sponsors to resolve issues.
The role involves performing pharmacovigilance activities as a Physician II. This typically includes monitoring drug safety and reviewing adverse event reports.
Conduct medical assessments of safety data and ensure the accuracy of case narratives and coding for regulatory submissions. Responsible for writing aggregate safety reports and contributing to risk management activities and safety monitoring.
The CRA II is responsible for delivering quality monitoring reports and conducting various site visits to ensure data integrity and patient safety. They must maintain the Trial Master File and verify that site documents are accurate and current according to ICH/GCP standards.
Associate Technical Project Manager - FS
Premier Research
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Full Time
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20 days ago
Premier Research
Assist in managing technical projects and collaborating with cross-functional teams to ensure milestone achievement and delivery. Maintain project timelines, monitor progress, and manage risks while serving as the primary point of contact for customers.
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.
Senior Trial Manager (Sponsor Dedicated)
Premier Research
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Full Time
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a month ago
Premier Research
Provides oversight and management of clinical trials, ensuring execution aligns with ICH/GCP regulations and project milestones. Responsible for coordinating trial operations teams, developing study documentation, and managing the selection and activation of investigative sites and vendors.
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.
The Senior Auditor will organize and host vendor audits to support global operations while ensuring compliance with internal controls and regulatory standards. They will also collaborate with operational teams to identify, trend, and resolve systemic vendor issues through formal documentation and corrective actions.
The Senior Director will manage key accounts and develop strategic client solutions to sell company services within the Italian and Swiss markets. They will also collaborate with international operation teams and partners to ensure high-quality proposals and successful client interactions.
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 clear communication with sponsors and internal teams. They will develop innovative trial designs, provide senior oversight for statistical deliverables, and advise clients on regulatory guidelines for submissions.
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.
The role involves preparing and submitting various regulatory applications, including Central EC/IRB, Local EC, and RA applications, as well as managing ongoing submissions and periodic notifications. Responsibilities also include essential document collection, negotiating site-specific contracts and budgets, conducting site feasibility, and ensuring the accuracy of Trial Master File documents.
