Premier Research

Director

• Lead the Study Start Up group, including SSUAs and SSUA Managers, within assigned regions
• Develop and execute business strategy aligned to project delivery
• Performance-manage and develop staff while striving for operational excellence
• Interact directly with clients to support repeat business
• Collaborate with Project Management, Clinical Leadership, and Business Development to manage contracts and client expectations
• Lead SSU activities including essential document collection, EC/IRB submissions, site initiation, Ethical Committee submissions, and close collaboration with site teams
• Drive process improvements and develop training materials
• Manage teams to deliver departmental metrics supporting business initiatives
• Resolve and escalate complex risks and issues using root-cause analysis
• Oversee SSU performance and teams within assigned regions
• Manage staffing, resources, and departmental utilization
• Drive teams to meet project timelines
• Partner with the VP to improve and streamline global SSU processes
• Collaborate with SSU management in the US and other regions
• Ensure SSU processes are proactive and completed according to contractual agreements
• Apply risk-management principles and identify productivity and cost-reduction opportunities
• Contribute to business development and proposal specifications
• Participate in metric reporting and management meetings
• Identify resourcing and staffing for new studies
• Manage and mentor direct reports, including training, performance management, and career development
• Prioritize multiple assignments in a fast-paced environment
• Ensure transition planning and stakeholder communication for staff changes
• Review and advise on SSU-related SOPs, WGs, and ADs
• Share knowledge with other managers
• Produce concise internal and external documentation and presentations

Director, Study Start Up – EU

General

• Manage all aspects of implementing Non-Disclosure Agreements, Clinical Trial Agreements, Contract Amendments, and associated documents for assigned studies
• Oversee Site Contracts with country experts during investigator site negotiations
• Lead negotiation of Site Contract templates with Sponsors and liaise between Sponsors and country experts
• Assist with developing and maintaining CTA, NDA, and other document templates to ensure compliance with local legal requirements
• Support the quality of all Site Contracts
• Identify site contract and budget-related risks and suggest mitigation solutions
• Represent the Premier Research Contracts Department during Sponsor Kick-Off meetings
• Oversee site contract-related study timelines, milestones, deliverables, and deadlines
• Review and advise on Regulatory and Clinical Operations SOPs, working groups, and advertisements related to NDAs, CTAs, investigator grants, and letters of authorization of Powers of Attorney

Senior Site Contracts Lead

Software Engineer

• Develop, validate, and support innovative statistical applications and technical solutions for clinical development and statistical programming
• Design, develop, test, and maintain interactive R Shiny applications for clinical trial activities
• Create user-friendly applications for statistical review, data exploration, quality control, and reporting
• Develop reusable Shiny modules and application frameworks
• Optimize application performance, scalability, and usability
• Develop reusable programming utilities using R, SAS, and Python
• Build applications supporting SDTM and ADaM review, dataset comparison, metadata review, TLF review and quality control, clinical data visualization, and statistical reporting
• Develop applications according to GxP, CSA, and company standards
• Execute unit, integration, and regression testing
• Provide technical consultation on R programming, R Shiny development, and open-source technologies
• Develop programs supporting project deliverables such as ADaM and TLFs
• Support study teams with programming activities
• Collaborate with Biostatisticians, Statistical Programmers, Data Management, Clinical Operations, and Information Technology

Senior R Programmer, Shiny Developer

Technician

• Maintain the lab library containing lab IDs, lab tests, lab test units, Standard Interventional unit conversions, unit conversion formulas, textbook reference ranges, lab test questions, and lab test codes
• Maintain lab IDs and update normal reference ranges in multiple databases
• Review lab slips and lab documents for normal reference ranges for protocol-required lab tests and create new lab IDs in the Clinical Data Management System (CDMS)
• Review and approve new lab test questions for addition into CDMS
• Review and provide lab test codes for all new lab tests
• Assist in CDISC Controlled Terminology mapping
• Assist in developing guidance documents supporting sites with collection of complete and accurate normal reference range documents
• Provide guidance for missing reference range documents, Note to File, and textbook reference range requests
• Assist in developing and updating lab-related SOP documents and guidelines
• Perform additional duties as assigned

Director, Study Start Up – EU

Senior Site Contracts Lead

Senior R Programmer, Shiny Developer

Medical Laboratory Technician