Clinical Study Manager- Oncology

IQVIA; Durham (NC); On-site; USD 93,000 - 233,000; Full time

Job summary

IQVIA is seeking a Clinical Lead to join the core project team and drive clinical delivery across global studies. You will ensure regulatory compliance, manage the clinical team, and collaborate with project leaders to meet contract requirements.

You'll lead recruitment strategies, monitor quality and risk, and support proposals with clinical delivery plans. Strong communication and leadership are essential to foster collaboration across geographies.

Qualifications

• Bachelor’s degree in health care or a scientific discipline required.
• Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience.
• Requires knowledge of GCP/ICH regulatory requirements.
• Broad protocol and therapeutic knowledge is needed.
• Understanding of project finances and EAC.

Responsibilities

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements and SOPs.
• Meet projects’ recruitment targets and ensure appropriate recruitment strategies.
• Contribute to the project risk mitigation plan and manage clinical risks.
• Ensure clinical quality delivery and monitor quality issues.
• Manage project finances including EAC and changes against baseline.
• Identify clinical stakeholder landscape and manage internal/external stakeholders.
• Collaborate with clinical team to support milestone achievements and report to stakeholders.
• Oversee resourcing and talent planning for the clinical team.
• Conduct regular team meetings and provide feedback for development.
• Contribute to clinical delivery strategy for proposals and bid defense.
• Mentor new peers and support large, global trials.
• Attend site visits as applicable.

Skills

Communication

Leadership

Problem solving

Organization

Prioritization

Quality focus

IT skills

Collaboration

Cross-cultural collaboration

Stakeholder management

Regulatory knowledge (GCP/ICH)

Education

Bachelor’s degree in health care or related field

Tools

Microsoft Office

Job description

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 inner 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 through the project’s 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.
• 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.
• May contribute to the development of the clinical delivery strategy for proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
• May mentor and coach new peers as they assimilate into this role.
• May work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
• May attend site visits as applicable in support of project delivery.

Qualifications

• Bachelor’s Degree in health care or other scientific discipline required Req
• Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience. Req
• Requires basic knowledge of Project management practices and terminology. Req
• Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.; Req
• Requires broad protocol knowledge and therapeutic knowledge.; Req
• Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates. Req
• Requires understanding of project finances. Req
• Knowledge of clinical trials - Knowledge of clinical trial conduct in addition to 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.
• 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 relationships with coworkers, managers and clients.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Effective communication - Ability to influence without authority.
• 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 $93,100.00 - $232,800.00. 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.