Associate Clinical Lead Director, Project Oversight
New Today
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.
Work strategically to realize clinical project goals including setting and developing clinical strategies.
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). 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.
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.
Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
Develop and present Clinical Operation
Plans in partnership with Business Development and Project Leadership.
Mentor and coach new peers as they assimilate into clinical lead roles.
May attend site visits as applicable in support of project delivery.
May participate in, champion and adopt function and/or corporate initiatives, changes and or special project assignments.
Travel up to 25%
Bachelor's Degree Health care or other scientific discipline Req
Requires 10 years clinical research/monitoring experience or equivalent combination of education, training and experience.
Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Requires consolidated knowledge of Project Management practices and terminology.
Requires good knowledge of project finances.
Knowledge of clinical trials - 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.;
Communication - Strong written and verbal communication skills including good command of English language.
Organization - Planning, time management and prioritization skills.
Quality - Attention to detail and accuracy in work.
Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.; including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
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 . IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
The potential base pay range for this role, when annualized, is $102,500.and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
- Location:
- North Carolina
- Job Type:
- FullTime
- Category:
- Health Professionals