Premier Research

• Manage FreshWorks support tickets from employees and coordinate the resolution within the 48-hour SLA • Manage user support requests, provide training and guidance on finance system processes, reports and functionality • Support Workday and OneStream administration, configuration and business process enhancements to improve operational efficiency and reporting accuracy • Analyze, document and maintain end-to-end data flows between Finance, HR, Operations, and IT systems to ensure data integrity and consistency • Perform data mapping and integration validation activities for system enhancements, process improvements and reporting requirements • Assist with system testing, user acceptance testing (UAT), and application upgrades • Develop report specifications by identifying data relationships, source systems, and reporting requirements within Workday and OneStream • Investigate and resolve data flow, integration, and reporting issues • Collaborate with cross-functional stakeholders to gather business requirements • Support month-end close activities by troubleshooting system-related issues and validating financial data across integrated platforms • Contribute to governance, documentation, and process standardization efforts across finance systems and reporting environments

Role Description Premier Research is looking for a Senior AI Developer to join our IT & Corporate Administration team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. The Senior AI Developer is responsible for designing, developing, and supporting enterprise‑grade AI solutions across Premier’s technology ecosystem. This role partners closely with business stakeholders, application end users, and global IT teams to: - Build AI‑powered integrations - Resolve day‑to‑day system issues - Lead implementation and upgrade projects - Provide best‑practice guidance on the use of AI tools including Microsoft Copilot, Anthropic Claude, and Azure AI Foundry What you will be doing: - Lead AI solution design and orchestration using Microsoft Copilot Studio, Claude Workflows, and Azure AI Foundry - Develop, test, and optimize AI prompts, workflows, and pipelines for enterprise use cases - Build and maintain integrations between AI platforms and corporate applications using REST APIs, webhooks, event‑driven architectures, and secure connectors - Implement RAG (Retrieval-Augmented Generation) using Azure AI Search, vector databases, and embedding pipelines - Deploy and manage custom MCP servers and agent UIs via Azure Container Apps - Develop and maintain automation scripts using Python, TypeScript, PowerShell, and other languages - Administer and configure Azure AI Foundry, including: - Prompt Flow - Model catalog (Azure OpenAI, Claude, Phi) - Safety evaluations - Deployment endpoints - Monitoring and observability - Agent Service configuration - Resolve AI‑related issues through Premier’s ticketing system while meeting SLAs - Lead AI platform upgrades, patches, and new feature rollouts with documented test cases and validation controls - Develop and maintain documentation for AI workflows, integrations, and business processes - Create knowledge base articles for Premier’s IT Service Management platform - Configure security models for AI applications, ensuring least‑privilege access and compliance with Responsible AI standards - Lead AI projects while keeping project team members, stakeholders, vendors, and IT leadership informed of issues and overall status Qualifications - Bachelor’s degree and 4–6 years of IT experience, or 6–8 years equivalent experience, supporting enterprise applications/AI systems - Hands‑on experience with Microsoft Copilot, Copilot Studio, Claude Workflows, and Azure AI Foundry - Strong understanding of LLM architecture, prompt engineering, AI safety, and model evaluation - Experience with Azure Container Apps for deploying custom MCP servers and agent front-ends - Experience with AI and integrating enterprise applications such as Workday, Salesforce, Cornerstone, or similar systems - Experience with Workday integrations (EIB, Core Connector, RaaS, Studio) is a plus - Proficiency in Python, TypeScript, SQL, .NET, JavaScript, and automation scripting is a plus - Experience with integration platforms such as Azure Integration Services, WSO2, or similar - Strong understanding of web services, APIs, XML, JSON, and XSLT - Fluent verbal and written English - Excellent team player; collaborative and consensus‑driven - Ability to multitask and work effectively in a fast‑paced environment with changing priorities - Strong communication, negotiation, organizational, and time‑management skills - Strong desire to learn new skills and expand technical experience - Accountable, dependable, and committed to delivering high‑quality results - Customer‑service‑focused approach to internal and external stakeholders - Ability to work both independently and within a team environment

Role Description Premier Research is looking for an Associate Principal Data Scientist (Data Manager) to join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You’ll Be Doing: - Interacts with internal and external project team members (including external data vendors) for multiple projects, as appropriate. - Actively contributes to study team discussions, standing meeting agendas, meeting attendance and review and/or documentation of minutes. - Facilitates clinical database development to execute collection, receipt, reporting, review and archiving of quality clinical trial data. - Includes eCRF planning discussions, coordination of eCRF review, planning and identification of system and protocol-specific edit checks, coordination and proper execution of User Acceptance Testing, and coordination, planning and development for external data sources as required. - Participates in early study team planning of data risk assessment and continuous evaluation of risks throughout course of study. - Offers insight and mitigates risks of data loss. - Communicates with assigned data team members to ensure tasks are coordinated and executed as per study plans and timelines as appropriate. - Ensures training of study-specific protocol requirements as appropriate. - Identifies and communicates gaps in training and supports training of data reviewers. - Responsible for oversight of study budget applicable to functional area. - Identifies and communicates potential out of scope activities to project team. - Works with study team to provide needed information for re-scoping when applicable. - Responsible for execution of all tasks as aligned with SOPs, department guidelines and data standards. - Reviews and contributes to evaluation, development and implementation of SOPs and department guidelines. - May assist in leading departmental initiatives and process improvements when required with support. Qualifications - Bachelor’s Degree preferably in Life Science required and Post Graduate preferred. - 8-12 years mastery in Data Management or relevant industry experience, with at least 5 years’ experience leading studies. - Experience working within several clinical data management systems and in-depth knowledge of at least two, preferably Medidata Rave or DataLabs EDC. - Knowledge of data standards and data modeling. - Knowledge of statistical principles and analysis considerations. Company Description Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

Role Description Premier Research is looking for a Project Specialist to join our Business Operations team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What you’ll be doing: - Partners with the Project Manager (PM) to ensure overall Project Delivery through coordination and oversight of the cross-functional project team. - Responsible for facilitating team communications and maintaining documentation internally and externally. - Maintains internal and external project team contact lists. - Ensures effective communication by scheduling internal and external team meetings, developing agendas, capturing minutes, and managing the action/decision log. - Creates and distributes study newsletters as required. - Manage and track budgets related to vendor projects including tracking of supplies and invoices. - Track out of scope services and assists in preparing Change Orders. - Tracks supplies, invoices, and budgets relating to vendor management, as appropriate. - Ensures projects are audit ready. - Creates and manages the required project systems, SOP indices, and study team lists, as applicable. - Manages study team/contact lists, system access requests, and e-mail distribution lists as required. Qualifications - Associate’s degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field and a minimum of 2 years of clinical research experience. - Alternatively, a Bachelor’s degree, or international equivalent, preferably in a clinical, biological, scientific, business, or health-related field, and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred. - Basic knowledge of ICH/GCP regulations. - Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures. - Basic knowledge of project management terminology and guidelines. - Strong computer skills in MS office suite required. Requirements - This role is offered as a 1 year Fixed Term Contract on Premier Research payroll. - Applications should be immediately available or only have a short notice period to be considered.

Role Description Premier Research is looking for a Clinical Trial Associate III, Sponsor-dedicated (contract) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What you'll be doing: - Assists in eTMF (electronic Trial Master File) filing and administration by submitting documents and/or files, conducting document review, supporting document query resolution, ensuring completeness, and conducting final site level review along with final document collection. - Creates and maintains tracking tools and database repositories for operational data including Key Performance Indicators (KPIs) and quality metrics. - Participates in project team meetings, prepares meeting minutes, and maintains action/decision logs. - Reports document collection and tracking issues to functional lead and/or study team, and assists more junior CTA team, as required. - Maintains clinical inspection readiness and supports regulatory inspections and/or audits as required. Qualifications - Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training, and experience. - 2 to 5 years of practical experience with clinical trial administration (e.g. – Inhouse CRA, CTA, site administration, clinical monitoring) preferred. - Strong knowledge of clinical studies and ability to support study team with functionality and use of TMF in accordance with study-specific TMF Plan, SOPs, and study-specific processes. - Strong communication and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities. Requirements - This is a 12-month 1099 contractor position with the potential to extend and renew after 1 year. Company Description Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

Role Description Premier Research is looking for a Site Contracts Lead to join our Clinical Strategy and Business Operations team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What you'll be doing: - Managing all aspects of implementing Non-Disclosure Agreements, Clinical Trial Agreements, Contract Amendments and other associated documents ensuring compliance. - Managing all steps of the process for initiation and completion of all Site Contracts in parallel with study start up timelines and site initiation projections. - Liaising with the client for reporting on the status and execution of all documents. - Negotiating the terms of all Site Contract templates with each Sponsor. - Assisting with the development and maintenance of templates for CTAs, NDAs and other documents as needed. Qualifications - Undergraduate degree or its international equivalent in legal studies or life sciences from an accredited institution. Law degree preferred. - At least 2 years of Contract Lead experience, including legal experience with contract language, escalation review, budget and template development, negotiations, direct interaction with Sponsor. - At least 1 year of related industry experience (CRO preferred). - Knowledge of basic requirements of contracts, non-disclosure agreements, powers of attorney and related documents. - Knowledge of Privacy Laws and regulations pertaining to cross border transfer of data. Requirements - This position is offered as an hourly paid contractor / freelancer. - It will be a full FTE with a contract duration of a year. - The successful candidate should be available at short notice and will ideally be set up to work in a freelance / contractor capacity.

Role Description Premier Research is looking for a Senior Clinical Research Associate, Sponsor-dedicated (Contract) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You’ll Be Doing: - Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records. - Issues, investigates, and resolves any data discrepancies identified during source verification activities. - Maintains thorough documentation and proper escalation of issues related to visit reports. - Ensures any identified non-compliance issues are addressed. - Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations. - Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database. - Performs budget negotiations with clinical trial sites. Qualifications - Experience in Neurology or Psychiatry, including work with Schedule I controlled substances, is required. - Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience. - 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Alternately, must have proven experience in all primary job functions. - Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities. - Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials. - Willingness to travel up to 70-85%. Requirements - This is a 1099 12-month contract position with the potential to extend and renew after 1 year. Company Description Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

Role Description Premier Research is looking for a In-House Clinical Research Associate I, Sponsor-Dedicated (Contract) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. - Partners with cross-functional team members and study sites throughout all phases to offer support of numerous trial elements for the clinical operation teams. - Carry out remote monitoring of clinical trials. - Serves as the secondary contact for sites supporting CRAs. - Responsible for the proper reporting and follow up of SAEs and ensures all reportable events are identified, clearly documented and reported per protocol as well as applicable requirements and regulations. - Ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. - Assists with audit/inspection readiness, study start-up activities, data listing reviews, monitoring visit support and issue resolution. Qualifications - Experience in Neurology or Psychiatry, including work with Schedule I controlled substances, is highly preferred. - Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience. - 3 to 5 years of practical experience in clinical trials. Alternately, a proven experience in all primary job functions. - Participate in study-specific meetings, teleconferences and training as needed. - Demonstrates excellent English verbal and written communication skills. - Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverable, and task ownership. - Preferred Location: East Coast / Central. Requirements - This is a 1099 12-month contract position with the potential to extend and renew after 1 year. Company Description Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

Role Description Premier Research is looking for a Software Quality Analyst to join our Interactive Response Tech (IRT) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. - Execute testing according to test plan and schedule - Apply software test methodology during execution of test plans - Assembly of validation output and data in compliance with government regulations - Perform unit testing of identified modules during the development phase - Perform additional duties and assignments as requested or assigned Qualifications - Bachelor’s degree or equivalent software validation experience required - Experience in software validation - Exceptional attention to detail and organizational skills - Strong problem-solving skills - Ability to stay productive while handling multiple tasks to meet deadlines in a dynamic environment - Strong written and verbal communication skills in English

Role Description Premier Research is looking for a Central Monitor I or II to join our Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You'll Be Doing: - Conduct ongoing reviews of clinical trial data using various technologies, analytic and visualization tools to monitor the quality of data, patient safety and relevant risks as per the Risk Assessment for the study. This may include review via data listings, study specific eCRF and aggregated data through ePremier tools. - Is responsible for monitoring site performance, data trending related to quality and site performance and escalation to the appropriate functional team lead through the regular use of ePremier data visualization tools. - As a Subject Matter Expert, utilize their previous broader clinical research experience and provide guidance to study team input to the development and update of the Risk Log for assigned projects. - Anticipate potential issues and resolve through potential action plans and documents corrective actions; provide direction to team members on complex study issues resolution. - Provide direction to site monitors along with the Clinical Lead, for additional remote and onsite monitoring activities for sites at risk, within the scope of the trial monitoring and clinical management plans. - Help to build efficiencies and the overall value from their previous broader clinical research experience and Risk Based Study Execution process at Premier. - Develops Risk Analytics Monitoring Plan for assigned studies. - Presents central monitoring findings to the internal team and sponsor teams on a predetermined frequency. Qualifications - Bachelors in the biological sciences, computer sciences, mathematics, or data sciences and/or related disciplines in the health care domain. Masters preferred. - 2-5 years Relevant experience in clinical research or related fields (Site-Operations, Monitoring On-site/Remote, Data Management, Hospital settings), global study experience, preferred. - 2-3 years Clinical research experience (site operations, monitoring On-site/Remote data management), global study experience, preferred. - Ability to use analytical tools to extracting knowledge and insight from data (data mining). - In-depth knowledge of ICH/GCP regulations FDA Guidance Documents, EU Directives. - In-depth knowledge of clinical monitoring procedures. - Fluent verbal and written English and presentation skills for business communication. - Must have proven track record of successful delivery, including effective management, multitasking and understanding of data, and accountability for quality and timelines. - Mentoring and guidance to other team members. - Ability to travel < 10%. Benefits - Fair and competitive compensation with market standards. - The minimum annualized starting base pay for level I is 25,500 Euro. - Actual salary influenced by qualifications, skills, competencies, and proficiency for the role. - Comprehensive benefits packages, which may include health insurance, life insurance, retirement plan, paid time off, and an Employee Assistance Program.