Sr, Study Process Lead

Job Overview
Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.

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.
• 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.
• Conduct regular team meetings and communicate appropriately to achieve objectives.
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
•  May work as the sole 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.

Qualifications

• Minimum 4-5 years of experience in the clinical trial industry (previous CRO employment).

• Excellent command of English language.

• Excellent command of Microsoft Office.

• Advanced knowledge of Project Management principles – Planning, Resourcing, Execution, Oversight, Risk Management (completed Project Management Fundamentals course is preferred, Advanced is a plus).

• At least 3 years of experience with Clinical Trial Management systems (CTMS) and/or Veeva Vault eTMF and/or EDC (Medidata).

• Preferably with previous client facing roles in Project Management / TMF Management / Clinical Operations Management / Site Management / Site Activation Management / Real World Evidence.

• Experience as Subject Matter Expert (SME) and/or Trainer and/or Mentor.

• Previous leadership role is a plus (Assoc Clinical Lead, Assoc Site Activation Manager, Centralized Monitoring Lead, TMF Manager, or Project Management Analyst / Senior or Principal Project Support Coordinator with minimum 2 years of experience in the role).

• Experience with Regulatory Management systems and Contract Management systems is a plus.

• Experience with advanced Excel features is a plus (Macros, Analytics).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.