IQVIA
StudyLead
Neural analysis suggests this role is
optimal for Senior candidates.
“Study Lead at IQVIA. Skills: clinical trial delivery, project management, stakeholder management, clinical quality. Ensure clinical delivery of assigned projects. Accountable for meeting projects’ recruitment targets”
What You'll Achieve.
meet contractual requirements; meet delivery requirements at all times; meeting projects’ recruitment targets; achieve objectives
Industry & Context.
Good judgment and decision-making skills; resolution management
not eligible for the UK visa sponsorship, only candidates based in the listed location/s will be considered
What They're Looking For.
Must Have
7 years clinical research/monitoring experience or equivalent combination of education, training and experience, consolidated knowledge of Project management practices and terminology, good knowledge of applicable clinical research regulatory requirements i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, broad protocol knowledge and therapeutic knowledge, good understanding of Clinical Research industry (drug/device/technology/etc. ) and the relevant environments in which it operates, understanding of project finances, Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i. e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct, written and verbal communication skills including good command of English language, Good influencing and negotiation skills, Good judgment and decision-making skills, Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues, Ability to work across geographies displaying a high awareness and understanding of cultural differences, Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership)
What You'll Do.
Ensure clinical delivery of assigned projects
Accountable for meeting projects’ recruitment targets
Contribute to the development of the project risk mitigation plan
Manage clinical risks through the project lifecycle
Ensure clinical quality delivery
Manage clinical aspects of Project Finances
Work as the primary Clinical Lead
Identify clinical stakeholder landscape
Collaborate with the clinical team
Resourcing and Talent Planning of the clinical team
Manage the clinical team at project level
Conduct regular team meetings
Support professional development
Adopt corporate initiatives and changes
Contribute to the development of the clinical delivery strategy
Participate in bid defense preparations
Develop and present Clinical Operation plan
Mentor and coach new peers
Attend site visits as applicable
How You'll Work.
Team & Collaboration
partnering with Project Leaders and other functional teams; Work as the primary Clinical Lead alongside other Clinical Leads; Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders; Collaborate with the clinical team to support milestone achievements; Report to internal and external stakeholders; Manage the clinical team at project level; Conduct regular team meetings and communicate appropriately; Support professional development by providing feedback to clinical team line managers; Ability to work across geographies displaying a high awareness and understanding of cultural differences
Communication Scope
written and verbal communication skills; good command of English language; influencing and negotiation skills; Effective mentoring and training skills
Process & Methodology
Project management practices, project risk mitigation plan, project lifecycle, project plans, Project Finances, Estimate at Completion (EAC), operational plans
Full Job Description
**Job Overview** Study Lead 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 (Standard Operating Procedures) 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. **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. Manage clinical risks through the project 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. • Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials. • Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management. • Collaborat
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