Associate Clinical Trial Management Director (ACTMD)

Parsippany, United States of America | Full time | Home-based | R1568388 Job Overview Associate Clinical Lead Directors are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Clinical Lead Director is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies or a program of studies to meet contractual requirements in accordance with (Standard Operating Procedures) SOPs, policies and practices. Associate Clinical Lead Directors ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams to ensure projects meet delivery requirements.

Essential Functions

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
• 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.
• Work strategically to realize clinical project goals including setting and developping clinical strategies.
• 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.
• Work as the primary Clini