You’re driven, resourceful, and above all else – remarkably smart.
You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.
Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.
Here, there’s no shortage of challenging work, learning and opportunities. Because we offer many services to varied clients, our knowledgeable professionals gain experience across a large section of the industry. Our client roster consists of more than 550 organizations including all 20 of the largest global biopharmaceutical companies.
This opportunity is with Syneos Health Consulting, an industry-leading consulting firm specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. You’ll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop achievable strategies for our clients.
We are currently recruiting for a Continuous Improvement Manager to join our team. The Continuous Improvement Manager will work with project teams supporting Syneos Health's biotech and pharma clients.
Quality & Compliance
The CIA is responsible for the development and maintenance of the QCI dashboard. They will
collaborate with Functional Area Heads within QCI and partner areas within Global Clinical
Trial Operations (GCTO) to collect and report key quality metrics. The CIA responsibilities are
- Accountable for the development and oversight of the QCI dashboard
- Collaborate with Functional Areas to collect key metrics for QCI dashboard
- Analyze key dashboard metrics to proactively identify trends and collaborate with relevant
- stakeholders to develop solutions to enhance performance
- Develop tools for trending audit findings, HA inspection findings and internal investigators,
- and proactively identify opportunities to enhance quality performance.
- Supports QCI and GCTO business operational activities as needed
The CIA will collaborate with GCD Lead Subject Matter Experts (SMEs), MRL Quality
Assurance (QA), RCQMs and Clinical Quality Management staff. Work with HQ functional
areas and regional roles to evaluate and improve global and regional processes, compliance, and
quality-related performance and metrics.
Process & Performance Metrics
- Responsible for tracking, analyzing and/or developing process, compliance, and quality-related metrics (eg., Quality Control Visits, Country/Headquarters QC Plan, audits and inspection findings) for Senior Management and regions. Liaise and lead with HQ functions and RCQMs for development of global tools to enable prompt review data and self-checks as needed. Run and develop analyses and reports for key stakeholders. Ensure global (plus regional and country as appropriate) data are available and accurate across databases and tools.
- Liaise and collaborate with Continuous Improvement function internally, GCD Lead SMEs, HQ Functional areas, GCQM, HQ CQM, MRL QA, and GCTO regions throughout issue resolution and/or risk mitigation on topics related to compliance, quality, audits, and inspections. Look for opportunities to improve quality without jeopardizing operational efficiency in trial execution in all levels with key stakeholders. Detect improvement needs, including training and improvement in process design and execution.
- Contribute to the design of company long-term Global Quality Management strategy together with QCI colleagues, GCTO Senior Leadership Team (SLT), and other key stakeholders. Support GCTO SLT and QCI in strategy planning by providing a data-driven overview of current performance and known issues and risks.
- Bachelor Degree or above is required in relevant area (e.g, life science, healthcare, or medicine)with extensive experience in clinical research.
- Minimum of 10 years of relevant experience in pharmaceutical industry, preferable direct field monitoring and clinical trial execution. Certified Lean Six Sigma Green Belt (or with the intention to be certified during the first few years in the position.) Knowledge and understanding of clinical development and clinical trial processes as well as quality and understanding of clinical development and clinical trial processes as well as quality management and control tools. Experience in project management, business process improvement and innovation, with demonstrated record of accomplishments. Direct experience in quality management, GCP auditing and/or supporting GCP inspections.
- Superior oral and written communication skills (in English) in an international environment. Excellent teamwork, leadership and influential skills. Excellent analytical skill and meticulous mind set to solve complex problems. Excellent consultative/facilitation skills with working knowledge of operational excellence tools and methodologies. Ability to think strategically and objectively and with creativity and innovation. Ability to work effectively in a culturally diverse, remote environment.
- Actively collaborate with Quality Improvement and Process Leads (QIPL) for the development and implementation of clinical quality management training programs for GCTO and Therapeutic Area staff.
Communication and Oversight
- Collaborates to create clinical quality management tools and procedures for conducting Clinical Trials at Merck investigative sites worldwide. Clinical Trial Process Improvement Collaborates with QIPL and Global Process Owners to initiate global clinical trial process improvement projects and liaise with RCQM/CCQM for successful execution of these projects.