Study Lead - Single Sponsor Dedicated in Reading

Study Leads 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 Senior Clinical Lead is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual requirements and in accordance with SOPs, policies and practices. Senior Clinical Leads ensure clinical delivery to customers by leading clinical teams and partnering with Project Leaders and other functional teams to ensure projects meet delivery requirements at all times.

Responsibilities

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans).
• Accountable for meeting project recruitment targets and ensuring appropriate recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan and manage clinical risks through the project lifecycle.
• Ensure clinical quality delivery by identifying quality standards, planning how compliance will be measured, and monitoring and addressing 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.
• Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
• Identify the clinical stakeholder landscape for the project and manage 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.
• Resourcing and talent planning of the clinical team.
• Manage the clinical team at project level to successfully deliver the project through 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.
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• May contribute to the development of the clinical delivery strategy for business proposals, participate in bid defense preparations, and develop and present the Clinical Operation plan in partnership with Business Development and Project Leadership.
• May mentor and coach new peers as they assimilate into this role and may attend site visits as applicable in support of project delivery.

Qualifications

• Bachelor's Degree in health care or other scientific discipline required.
• Requires 7 years of clinical research/monitoring experience or an equivalent combination of education, training, and experience.
• Requires consolidated knowledge of project management practices and terminology.
• Requires good knowledge of applicable clinical research regulatory requirements (GCP and ICH guidelines).
• Requires broad protocol knowledge and therapeutic knowledge.
• Requires good understanding of the Clinical Research industry and the environments in which it operates.
• Requires understanding of project finances.
• Knowledge of clinical trials and ability to apply regulatory requirements to clinical trial conduct.
• Communication – strong written and verbal communication skills in English; leadership, negotiation, and mentoring abilities; cross-collaboration across geographies.