Senior Central Risk Manager – Sponsor Dedicated

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Offer subject matter expertise to develop project monitoring strategies and provide updates based on identified risks.

• Collaborate with cross-functional leads to comprehend complex indications and risks, while identifying mitigations for those risks.

• Provide guidance to maintain consistency across various programs, therapeutic areas, and sponsors.

• Draft preliminary risk assessments and assist in the finalization of the Risk Assessment Categorization Tool (RACT).

• Ensure that identified risks are appropriately documented in the designated tracking system and support ongoing cross-functional risk evaluations.

• Advise on action plans to mitigate identified risks effectively.

• Evaluate tools for remote data review and centralized statistical monitoring.

• Facilitate the review of findings with internal cross-functional teams and sponsors.

• Collaborate to establish Quality Tolerance Limits.

• Design and deliver training on risk assessment, centralized monitoring, and the implementation of risk-based monitoring strategies.

• Work across functions to guarantee compliance and delivery in accordance with protocol, ICH/GCP, GPP, and applicable country regulations.

• Ensure inspection readiness concerning the risk assessment and centralized monitoring scope.

• Comprehend the assigned study scope, budget, and protocol; escalate any at-risk timelines, quality issues, and budget deliverables to the Project Manager.

• Engage in business development activities, which include contributions to monitoring strategy and budget input, meetings, and proposal development.

⛳️ Requirements

• Equivalent experience, skills, and/or education may also be considered.

• Familiarity with complex indications and associated risks.

• Understanding of risk-based monitoring, centralized monitoring, remote data review, and centralized statistical monitoring.

• Knowledge of compliance and delivery requirements according to protocol, ICH/GCP, Good Pharmacoepidemiology Practices (GPP), and country regulations.

• Comprehension of study scope of work, budget, and protocol content.

• Ability to collaborate effectively with cross-functional leads, sponsors, medical monitoring, and Quality Assurance teams.

• Capacity to assess risks concerning data quality and integrity.

• Ability to support readiness for inspections.

• Capability to escalate deliverables that are at risk and manage out-of-scope activities.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Comprehensive total rewards program.

• An inclusive culture where employees can truly be themselves.