Clinical Trial Manager II, IQVIA Biotech

IQVIA; Columbia (MD); On-site; USD 120,000 - 170,000; Full time

Job summary

IQVIA Inc in Columbia, Maryland is seeking a Clinical Lead to join the core project team delivering clinical studies in compliance with GCP/ICH and SOPs. The role requires leading clinical teams, coordinating with Project Leaders, and ensuring recruitment targets are met across global trials.

You will manage project finances, quality delivery, and risk mitigation while mentoring peers and supporting bid defenses. A strong collaboration across geographies is essential.

Qualifications

• Bachelor's Degree in health care or other scientific discipline is required.
• Requires 5 years clinical research/monitoring experience or equivalent.
• Familiarity with project management practices and terminology.
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Broad protocol and therapeutic knowledge in clinical trials.
• Understanding of project finances and commercial aspects.

Responsibilities

• Ensure clinical delivery of assigned projects in compliance with regulatory, contract, and SOP requirements.
• Meet recruitment targets and implement recruitment strategies.
• Develop and manage project risk mitigation plans and clinical risks.
• Ensure clinical quality delivery and monitor quality issues.
• Oversee project finances including Estimate at Completion and changes to baseline EAC.
• Identify and manage clinical stakeholders and maintain effective communication.
• Collaborate with clinical teams to support milestones and report to stakeholders.
• Plan resourcing and training for the clinical team and conduct team meetings.

Skills

Clinical leadership

Project management

Regulatory compliance

ICH/GCP knowledge

English communication

Stakeholder management

Risk management

Team mentoring

Education

Bachelor's Degree in health care or scientific discipline

Tools

Microsoft Office

Excel

PowerPoint

Word

Job description

Mexico City, Mexico

Buenos Aires, Argentina

Mexico City, Mexico

Columbia, Maryland, United States of America

Full time

R1576940

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 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 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 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 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.

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.

EEO Minorities/Females/Protected Veterans/Disabled