Project Lead-Decentralized Clinical Trials

Project Manager-Remote Research Clinician/DCT

Location: Home-based in the U.S.

Job Overview

Remote Research Clinicians (RRC) Project Leads play a critical role in clinical trial delivery, helping improve patients' lives by bringing services directly to them. As the primary point of contact, the RRC Lead collaborates closely with Sponsors, Sites, and clinicians, while coordinating across a network of internal and external cross-functional stakeholders. RRC Leads operate independently to manage a diverse portfolio of protocol-driven projects, delegating visit coordination tasks to assigned Regional Specialists. This position provides comprehensive project oversight, ensuring exceptional quality and seamless execution for all stakeholders.

Essential Functions

• Direct and independent leadership of a portfolio of global RRC projects, ensuring all-around success
• Effective communication and stakeholder management, including Sponsors, Sites, and numerous cross-functional teams
• Financial oversight, including budget creation, time/scope alignment, EAC forecasting, invoicing, change orders, and modeling
• Document creation, including project plans, study trackers, meeting PPTs, and communications
• Metrics creation and management
• Direct training of coordinators, sites and clinicians
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Adopt corporate initiatives and changes and serve as a change advocate when necessary
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development

Qualifications

• Bachelor's Degree Life sciences or related field• 5+ years of prior relevant experience in clinical research roles, including > 3 years in a Project Manager role
• Previous experience working directly with clinical research sites
• Previous experience with remote visits and clinicians (RN, RD, phlebotomist) would be ideal
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.
• Fluent written and verbal English is mandatory