Associate Clinical Lead Director- CAR-T and Cell Gene Therapy

IQVIA LLC; Durham (NC); On-site; USD 177,000 - 296,000; Full time

Job summary

IQVIA LLC is seeking an Associate Clinical Lead Director to drive clinical delivery on large, multi-regional studies, collaborating with clinical teams to bring new drugs to market efficiently.

The role leads project teams, manages budgets and risk, and ensures adherence to ICH-GCP SOPs while mentoring staff across global studies.

Qualifications

• Bachelor's Degree in Health care or other scientific discipline required.
• 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 ICH guidelines.
• Requires consolidated knowledge of Project Management practices and terminology.
• Requires high proficiencies in using systems and technology to achieve work objectives.
• Knowledge of clinical trials and applicable regulatory requirements in ICH/GCP.
• Strong written and verbal English communication skills.

Responsibilities

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements and customer requirements.
• Accountable for meeting recruitment targets and recruitment strategies.
• Develop project risk mitigation plans and manage clinical risks.
• Lead clinical teams and collaborate with Project Leaders and other functions.
• Manage project finances including EAC and changes against baseline.
• Mentor and coach peers; participate in bid defenses and clinical operation plans.
• May attend site visits and support cross-functional initiatives.

Skills

Clinical trial mgmt

GCP/ICH knowledge

Project management

Regulatory compliance

Stakeholder management

Budget management

English communication

Education

Bachelor's Degree health care or scientific discipline

Tools

Microsoft Office

Clinical trial systems

Job description

Job Overview

Associate Clinical Lead Directors 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 Associate Clinical Lead Director is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies or a program of studies to meet contractual requirements in accordance with (Standard Operating Procedures) SOPs, policies and practices. Associate Clinical Lead Directors ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams to ensure projects meet delivery requirements.

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 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). 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.
• 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.
• 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 business proposals. Participate in bid defense preparations and meetings. 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 act as departmental cross-functional liaison and/or change agent.
• 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.

Qualifications

• 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 high proficiencies in using systems and technology to achieve work objectives.
• 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.
• Problem solving - Problem solving skills.
• Organization - Planning, time management and prioritization skills.
• Prioritization - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work.
• Results-oriented approach to work delivery and output.;
• Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. 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.;
• Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. 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.
• Collaboration - Ability to establish and maintain effective working.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

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. Learn more at https://jobs.iqvia.com 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. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $106,100.00 - $295,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; 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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.