• Coordinate assigned projects from initiation through completion, delivering both on-time and within budget • Be the point of contact and coordinate all departments necessary for the projects • Manage resources with peers and functional managers • Identify and manage project risks and issues • Report on project budgets • Provide frequent project status to management and project teams • Create long- and short-term plans, setting targets for milestones and adhering to deadlines • Develop and manage Activation and Operations Readiness plans for new hospital openings

Role Description Premier Research is looking for a Director, Global Clinical Quality to join our Global Quality 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: - Ensures that each BU Quality Lead performs individual protocol assessments, Critical to Quality data and process, safety, and data integrity risks related to protocol startup, execution and close out. - Develop and implement ongoing initiatives to assess potential clinical quality risks, including data integrity issues and drive identification, mitigation and prevention. - Identifies/facilitates key quality improvements and innovation. - Drives vision of continuous state of regulatory preparedness. - Supports and mentors the operational teams from a Quality perspective. - Works with Risk Based Quality Management oversight leaders from operational teams in development of initial risk assessments and identification guidance for potential study specific risks. - Leads/mentors both Quality and Operational Leads in evaluation. - Mentors Quality and Operational teams in collaboration with Clinical leadership in implementing a systematic approach to corporate and clinical governance, risk management policy. - Ensures the immediate communication and escalation of serious issues and signals of concern to the project team and mentors the operational team through the development of action plans. - Oversees the documentation of observations noted during reviews, investigates trends, issues and risks for root cause. Qualifications - Bachelor’s degree in Life Sciences or related field. - 5-7 years in a lead Operations role at a clinical site/system research facility. - 5-7 years of industry experience in a Quality leadership role. - Strong knowledge of ICH-GCP, FDA, ISO, and other global regulatory requirements. - Expert in Risk-Based and Critical to Quality Strategies at the clinical trial level throughout the project lifecycle. - Must demonstrate strong computer skills and be able to embrace new technologies. - Mastery of Analytical Data Visualization Tools and techniques preferred. - Demonstrated Leadership and mentorship capabilities in leading teams with a proactive, Quality by Design approach to deliverables. Benefits - Annualized minimum base pay for this role is $151,000 USD. - Actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. - Comprehensive benefits package, which may include health insurance, retirement plans, and paid time off. 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.

• Ensure and support GCP-compliant planning and execution of clinical studies • Oversee GCP-compliant monitoring of outsourced Clinical Operations activities • Contribute to the selection and qualification of GCP/GCLP vendors • Lead project reviews and manage processes • Provide operational support to central laboratories • Perform administrative clinical trial tasks

Role Description Premier Research is looking for an Associate Manager, Clinical Operations to join our Global 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. - Manages clinical operations employee resources and employee resource projections to ensure that project teams meet client expectations and contractual obligations. - Interfaces with other departments to design cross-functional process efficiencies or develops new approaches to the clinical management and monitoring of clinical trials considering Phase I - IV paradigms. - Ensures audit preparedness of Clinical Operations employees, including training records, processes, and SOP compliance. - Reviews RFP’s, assesses monitoring strategies and resources to support budget development. - Participates in Business Development presentations as appropriate. - Oversees staff utilization and productivity. - Participates in the recruitment, retention and ongoing professional development of Clinical Operations employees. Qualifications - Recognized undergraduate degree is required. A degree in Pharmacy, Biology, Chemistry, Psychology, Nursing or a related discipline is preferred. - Minimum of 4 - 6 years clinical research experience. - 0 - 2 years supervisory / management experience. - People manager experience encouraging teamwork and developing team capabilities. - Proven interpersonal skills able to work and lead efficiently within a matrix environment. - Ability to drive projects to a successful completion both as a project leader and within a leadership role.