
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
🕒 August 21
🇬🇧 United Kingdom – Remote
⏰ Full Time
🟠 Senior
🎲 Risk
🇬🇧 UK Skilled Worker Visa Sponsor
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10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
• Provide subject matter expertise for developing project monitoring strategies and advise on updates based on risks • Work with cross-functional leads to understand complex indications and risks and identify risk mitigations • Provide guidance to ensure consistency across programs, therapeutic areas, and sponsors • Draft initial risk assessments and support finalization of the Risk Assessment Categorization Tool (RACT) • Ensure identified risks are transferred to the correct tracking system and support ongoing cross-functional risk reviews • Advise on functional plans to mitigate identified risks • Assess tools for remote data review and centralized statistical monitoring • Facilitate review of findings with internal cross-functional teams and sponsors • Collaborate to identify Quality Tolerance Limits • Develop and deliver training on risk assessment, centralized monitoring, and risk-based monitoring strategy implementation • Collaborate across functions to ensure compliance and delivery according to protocol, ICH/GCP, GPP, and country regulations • Ensure inspection readiness for risk assessment and centralized monitoring scope • Understand assigned study scope, budget, and protocol; escalate at-risk timeline, quality, and budget deliverables to the Project Manager • Participate in business development, including monitoring strategy and budget input, meetings, and proposal development
• Equivalent experience, skills, and/or education will also be considered • Understanding of complex indications and risks • Knowledge of risk-based monitoring, centralized monitoring, remote data review, and centralized statistical monitoring • Knowledge of compliance and delivery according to protocol, ICH/GCP, Good Pharmacoepidemiology Practices (GPP), and country regulations • Understanding of study scope of work, budget, and protocol content • Ability to collaborate with cross-functional leads, sponsors, medical monitoring, and Quality Assurance • Ability to assess risks to data quality and integrity • Ability to support inspection readiness • Ability to escalate deliverables at risk and out-of-scope activities
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture where employees can authentically be themselves
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