Central Risk Manager (Risk based Central Monitoring)
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Job responsibilities
- Provides advice and subject matter expertise for the development of the monitoring strategy required for the project and where required, advises the project team on any updates to the monitoring strategy during the study based on risks.
- Works with cross-functional leads to understand complex indications and risks and seeks input on risk mitigations. Provides guidance to cross-functional leads to ensure consistency within programs, therapeutic areas and/or sponsors.
- Drafts initial risk assessment, supports the project team in ensuring cross-functional involvement in the finalization of the RACT.
- Ensures PL transfers risks identified to the correct tracking system and supports ongoing cross-functional review of risks throughout the project.
- Provides advice on the development of functional plans to ensure identified risks are mitigated.
- Assess tools where available to conduct remote data review and centralized statistical monitoring, identifying risks to data quality and integrity.
- Facilitates review of findings with the internal cross- functional team and sponsor. Requires support from cross-functional leads on complex risks and mitigations.
- With support and where required, collaborates with other team members and Sponsor to identify Quality Tolerance Limits.
- As required, provides development and delivery of initial and ongoing training to the study team regarding the risk assessment, centralized monitoring and the wider risk-based monitoring strategy.
- Coaches and mentors peers regarding functional delivery, evaluation of project risks, and action implementation.
- 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.
- Understands the study scope of work, budget and protocol content for their assigned study.
- Escalates to the PM any risk assessment and centralized monitoring deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope.
- May participate in business development activities including monitoring strategy and budget input, defines meetings and proposal development.
Qualifications - External
What we’re looking for
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
- Master's degree or health data sciences degree preferred.
- Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.
- Expert in Risk-Based Monitoring Strategies processes and tools preferred.
- Expert in Integrated Quality Risk Management (IQRM) theories.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Mastery of MS Excel (sorting, filtering, calculating, pivoting).
- Mastery of Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze, identification of trends and outliers).
- Knowledge of statistical analysis techniques, visualizations and tools (Cluepoints, Medidata-CSA, Hy's Law, Funnel Plots, Box and Whiskers).
- Knowledge of Lean Six Sigma, RACT tools.
- Strong analytical skills and well-developed understanding of statistical concepts.
- Well-developed therapeutic expertise.
- Excellent verbal and written communication skills.
- Strong negotiation skills, organizational skills and problem-solving skills.
- Demonstrated strong leadership, tactical and strategic thinking skills.
- Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.
- Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.
- Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas, and ability to work across those functional areas.
- Ability to understand, explain and communicate project concepts and put into detailed plans.
- Ability to teach, train and mentor employees of all levels to achieve project, departmental, personal and organizational goals.
- Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
- <30% travel (departmental meetings, investigator meetings, training, client meetings and bid defenses).
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
