Risk Strategist

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today. We’re looking for a** Risk Strategist **join our** Global Functions **team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. **What you’ll be doing**: The Risk Based Data Strategist: - Facilitates delivery of customized training programs for company staff using proprietary risk-based quality management technology - Coaches project teams to utilize the technology to best support their clinical studies - Is responsible for building expertise within the Premier organization on holistic, quality data review of clinical data - Catalyst to improving the teams’ knowledge of risk-based quality management functionality to increase clinical efficiencies and effectiveness - May provide support to Business Development (including monitoring strategy and budget input, and proposal development) to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations, data acquisition and RBQM guidance where required. - Guides internal teams and sponsors through and documents the key decisions needed to implement a high quality, efficient RBQM solution - Where sponsors desire to incorporate new data sources, technologies or processes to support RBQM, strategizes with internal team members and sponsors to agree on "hybrid" approach that is efficient and effective - Works with internal team members and sponsors to ensure access to data needed to execute RBM according to the agreed plan and guides the team in creation of an integrated data review strategy that is fit for purpose.(IDRP) - Works with cross-functional leads to understand complex indications and risks and seeks input on risk mitigations and provides expertise and suggestions on data acquisitions strategies. - Collaborates with other functional areas to ensure risks identified in compliance and delivery according to protocol, ICH/GCP and/or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA). - Ensures Inspection Readiness for risk assessment and centralized monitoring scope. - Participate in corporate initiatives and actions that ensure the continued adoption of a risk-based approach to trial design and quality management. - Complete risk assessment documentation and UAT documentation for all quarterly and hot fix releases of the risk-based quality management software. - Provide demonstrations of the risk-based quality management software for prospective clients and internal staff **You’ll need this to be considered**: - Undergraduate degree or its international equivalent in clinical, science or health related field from an accredited institution or a licensed healthcare professional. - Preferred education in health data analytics and/or informatics. - 5+ years of related experience (health sciences, allied health, IT). - Prior training experience in a variety of settings, including small/large groups, classroom, on-line, etc. preferred. - Clinical trials support or pharmaceutical industry experience required. - Knowledge of ICH and local regulatory authority drug research and development regulations required. - Navigation of business intelligence tools and regular use of data visualizations for decision making. **Why choose Premier Research?** - Premier Research is more than a company - it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. - Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. - Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful. At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think