Associate Director, Central Monitoring
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
• Provides expert risk-based monitoring strategy, oversight and guidance to support internal teams and sponsors.
• Guides internal teams and sponsors through and documents the key decisions needed to implement a high quality, efficient RBM /IQRM solution.
• Where sponsors desire to incorporate new data sources, technologies or new/supplemental/substitute processes to support RBM, 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.
• Provides expert operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others.
• Analyzes performance and quality metrics to assure BU achievement of quality and compliance expectations related to patient safety and data integrity as well as RBM success measures.
• Address improvement initiatives as identified.
• Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP.
• Oversees progress of teams supporting clinical projects.
• Ensures individual and team tasks are completed according to country/region specific and government regulations and per Sponsor/Customer expectations and contract.
• Develops and supports customer relationships, manage customer expectations and escalates more serious issues as required.
• Works closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors.
• Identifies needs and may make recommendations for process improvement and efficiencies.
• Participates in committees and work groups to support the development and implementation of new initiatives and strategic direction of the BU and cross-BU Clinical Operations.
• May provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required.
• May participate in marketing activities, client presentations and proposal development.
• Line Management of Central Monitoring Specialists and Risk Managers, responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/counseling of staff.
• Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
• Liaises with resourcing management on active awarded and proposal project assignments.
• Reviews workload, utilization, productivity, and quality for staff in reporting chain.
• Manages the resource availability for the assigned staff, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions.
• Supports the assessment of overall staff growth and actively participate in the selection and hiring process.
• Proactively works to ensure staff retention and turnover rates remain within expected levels.
• Ensures all staff follows required training and completes the required documentation.
• Provides regular compliance updates to management accordingly.
• Participates in audits of central monitoring/clinical monitoring related to RBM/IQRM strategy and implementation.
This job excludes CO applicants.
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.
• Knowledge of and relationships with industry thought-leaders in RBM and IQRM.
• 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.
• Ability to travel as necessary (approximately 30%)
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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.
Primary Location: North America - US Home-Based
Job: Clinical Monitoring
Travel: Yes, 25 % of the Time
Employee Status: Regular