Job Overview

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 Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies, and practices. Clinical Leads ensure clinical delivery to customers, lead clinical teams, and partner with Project Leaders and other functional teams, ensuring projects meet delivery requirements 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).
• Be 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 lifecycle.
• Ensure clinical quality delivery by identifying quality standards and requirements, planning how compliance will be measured, and 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 EAC and identify additional service opportunities or out-of-scope work.
• Identify the 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 and report to internal and external stakeholders as per project scope requirements.
• Lead resourcing and talent planning of the clinical team. Manage the clinical team at project level through the establishment of high-quality operational plans, 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.
• Contribute to the development of the clinical delivery strategy for proposals. Participate in bid defense preparations and meetings. Develop and present the Clinical Operations Plan in partnership with Business Development and Project Leadership.
• Mentor and coach new peers as they assimilate into the role.
• Work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
• Attend site visits as applicable in support of project delivery.

Qualifications

• Bachelor’s Degree in healthcare or another scientific discipline required.
• At least 5 years of clinical research or monitoring experience, or an equivalent combination of education, training, and experience.
• Basic knowledge of project management practices and terminology.
• Good knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Broad protocol and therapeutic knowledge.
• Good understanding of the clinical research industry (drug, device, technology, etc.) and the environments in which it operates.
• Understanding of project finances.
• Knowledge of clinical trial conduct and the ability to apply applicable clinical research regulatory requirements, including ICH, GCP, and relevant local laws, regulations, and guidelines.