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Clinical Risk Lead

Responsible for the oversight of risk management activities on a portfolio of clinical projects in accordance with ICH GCP E6 requirements.

The Clinical Risk

Lead will coordinate the development of project specific risk assessments, risk management plans and Integrated Strategic Monitoring Plans (ISMPs) during study start‑up whilst driving compliance to these plans throughout the project lifecycle.

The Clinical Risk

Lead will maintain the risk library and provide guidance to ensure consistency within the organization in terms of risk assessment and management.

The Clinical Risk

Lead will assist in the development of the clinical monitoring strategy, and the application of RBQM principles to other functional plans in collaboration with other functional leads and, where required, will develop and deliver training to the study team regarding the risk assessment and the clinical monitoring strategy.

Risk Management Activities

Coordinate and conduct an initial risk assessment during the request for proposal and bid‑defense stages with the key stakeholders from each department.
Lead the cross‑functional project team in identifying critical variables and key study‑specific risks using the risk assessment tool and key risk indicators library post study award.
Assist with the creation and maintenance of the project specific Risk Management Plan.
In conjunction with Data Management and the project team coordinate the project specific QTL build at study start and reviews throughout the project.
Work with the study team to develop the study’s Project Plans & ISMP, including but not limited to Monitoring Plans (On‑site, Central, Remote), under the direction of the Project Manager.
Communicate and coordinate risk identification and management activities with the cross‑functional team on study‑specific risks identified at specified timepoints.
Develop and recommend risk mitigation strategies by working with cross‑functional teams to document and elevate issues identified, develop and track strategies to mitigate them, and conduct root cause analysis to institute corrective and preventative action plan.
Conduct periodic reviews of Risk Management Plans as well as previously and newly identified risks.
Update Risk Management Plan and any other Project Plans based on updated risk assessment.
Coordinate project specific user access reviews of the Risk Management system.

Study Documents and Plans

Develop and deliver training to the study team regarding the risk assessment, centralized monitoring and the wider risk‑based monitoring strategy.
Development and maintenance of Risk Library.
Development of Project Plans to manage identified risks.
Draft initial Risk Assessment with risk planning tool and support from cross‑functional team.

Subject Matter Expert

Provide coaching for cross‑functional team as needed regarding functional delivery, evaluation of project risks and plans to mitigate risks identified.
Provide expertise for the development and maintenance of the monitoring strategy required for the trial based on identified risks.
Review study protocols to highlight any areas of risk.
Provide input related to clinical monitoring services on proposal for business development.
Present to internal/external clients on Risk Management and oversight.
Become SME on the Risk Management System(s) used within the organization and deliver training on the system(s) as required.
Participate and contribute to process improvement initiatives and business projects.

Other Responsibilities

Participate in the development and ongoing review of the risk management process.
Stay informed on current interpretations and application of regulatory expectations in terms of risk management.

Qualifications

Minimum of an undergraduate degree and 4‑6 years of relevant experience (including a minimum of 3 years in clinical trials), with knowledge and prior experience of Risk Based Quality Management concepts.
Proficiency with MS Office, strong written and verbal communication skills, and highly effective interpersonal and organizational skills.
Demonstrated attributes: proactive, detail‑oriented, critical thinker, task‑driven and highly organized.
Ability to apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical trial, and ability to work in a global environment and cross‑functional team.