ResponsibilitiesThis 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.
Under the guidance of HQ CQM Lead, the HQ CQM Contractor will oversee clinical quality management within the Therapeutic Area supporting Clinical Trial Teams to proactively embed quality into sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.
The candidate will be responsible for the development of Quality Plans to implement Quality by Design within Clinical Development Programs, using a risk based approach and collaborating with Clinical Trial Teams in implementing and executing Quality Control activities.)
HQ CQM: CORE Accountabilities and Responsibilities
Provides input and approves trial specific monitoring plans.
Supports qualification and quality management of global vendors.
Supports Clinical Trial Teams to ensure state of inspection readiness throughout the course of a trial.
Audit and Inspection Support:
Quality Signal Detection:
Develops and manages targeted QCV process, including the analysis and development of appropriate action plans in agreement with defined thresholds.
Develops and manages Quality Plan throughout the course of a trial.
Education: Bachelor Degree or equivalent in relevant health care area
A minimum of 5 years of relevant experience in clinical research
Knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management and control tools.
Experience in design of Clinical Trials, Clinical Trial Operations, therapeutic area specific clinical assessments and/or medical practice is preferred.
Direct experience in quality management, GCP Auditing and GCP Inspections is an asset.
Experience delivering effective CAPA management solutions is an asset.
Superior oral and written communication skills in an international environment.
Project management and organizational skills.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Ability to analyze, interpret, and solve complex problems.
Ability to think strategically and objectively and with creativity and innovation.
Ability to proficiently interact with all levels of management and exert influence to achieve results.
Flexible (East Coast or Central or Remote)
Remote candidates should be flexible to come to the office for 1 – 2 weeks for onboarding
Remote candidates should be flexible to come to the office in the event of a Sponsor Inspection for the project they are assigned
Remote candidates should be flexible to come to office in the event of an important face-to-face meeting (infrequent)