Clinical Trial Manager II, Oncology - IQVIA Biotech, Mexico

MSC Quintiles Mexico S. de R.L. de C.V.; Ciudad de México; Presencial; MXN 600,000 - 800,000; Jornada completa

Descripción de la vacante

A leading clinical research company in Mexico is seeking a Clinical Lead to oversee clinical trial delivery. The role involves ensuring compliance with regulatory requirements, managing clinical teams, and achieving recruitment targets. Candidates must have a bachelor's degree in a health care field and considerable clinical research experience. Strong communication and leadership skills are essential.

Formación

• 5 years of clinical research or monitoring experience.
• Good knowledge of ICH and GCP guidelines.
• Understanding of project finances.

Responsabilidades

• Ensure compliance with regulatory requirements.
• Manage clinical risks throughout the project lifecycle.
• Collaborate with clinical teams for milestone achievements.

Conocimientos

Clinical research experience

Project management knowledge

Strong communication skills

Problem solving skills

Attention to detail

Leadership and mentoring skills

Educación

Bachelor's degree in health care or scientific discipline

Herramientas

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Descripción del empleo

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.

Responsibilities

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP), protocol, customer requirements (contract), and internal requirements (policies, 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 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.
• Requires 5 years of clinical research/monitoring experience or equivalent combination of education, training and experience.
• Requires basic knowledge of project management practices and terminology.
• Requires good knowledge of applicable clinical research regulatory requirements (GCP and ICH guidelines).
• Requires broad protocol knowledge and therapeutic knowledge.
• Requires good understanding of the Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
• Requires understanding of project finances.
• Knowledge of clinical trials and clinical trial conduct, including applying applicable clinical research regulatory requirements (ICH, GCP) and relevant local laws, regulations and guidelines.
• Communication: Strong written and verbal communication skills including good command of English language.
• 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: Proficient software and computer skills, including 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 with awareness 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).

About IQVIA

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