Associate clinical lead

Project role : Associate clinical lead

Work experience : 5 to 10 years.

Work location : Homebased.

Must have skills : Senior Clinical Research associate , CRA, Unblinded Monitoring, Onsite Monitoring.

Job overview : Unblinded Clinical Lead working as a oversight for global unblinded CRA team as well as providing technical support for Unblinded clinical operations.

Job Responsibility :

Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.

Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle.

Ensure clinical quality delivery by identifying quality standards / requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.

Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.

Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.

Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.

Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.

• May work as the Unblinded Clinical Lead on projects with 1-2 service lines and single / few countries or alongside more senior Clinical Leads to deliver large, global trials.;

May attend site visits as applicable in support of project delivery.

Technical Skills :

Requires 5+ years clinical research / monitoring experience or equivalent combination of education, training and experience

Unblinded Monitoring experience preferred.

Requires good understanding of Clinical Research industry (drug / device / technology / etc.) and the relevant environments in which it operates.

Requires basic understanding of project finances