Senior Clinical Trial Manager, Oncology - Iqvia Biotech, Mexico

Overview

Job Overview

Senior Clinical Leads 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 Senior Clinical Lead is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual requirements and in accordance with SOPs, policies and practices.

Senior Clinical Leads ensure clinical delivery to customers by leading clinical teams and partnering with Project Leaders and other functional teams to ensure 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.

Manage clinical risks through the project 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.

Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.

Identify clinical stakeholder landscape for the project and manage 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 to support professional development.

Adopt corporate initiatives and changes and serve as a change advocate when necessary.

May contribute to the development of the clinical delivery strategy for business 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 attend site visits as applicable in support of project delivery.

Qualifications

Bachelor's Degree in health care or other scientific discipline required.

Requires 7 years of clinical research / monitoring experience or an equivalent combination of education, training and experience.

Requires consolidated knowledge of project management practices and terminology.

Requires good knowledge of applicable clinical research regulatory requirements (GCP, ICH) and relevant local laws and guidelines.

Requires broad protocol knowledge and therapeutic knowledge.

Requires good understanding of the Clinical Research industry and the environments in which it operates.

Requires understanding of project finances.

Knowledge of clinical trials and clinical trial conduct, and the ability to apply regulatory requirements (ICH / GCP) and local laws.

Strong written and verbal communication skills including good command of English.

Problem solving, organization, prioritization, attention to detail, and a results-oriented approach.

Leadership, negotiation, mentoring and training skills.

IT skills with proficiency in Microsoft Word, Excel and PowerPoint.

Ability to establish and maintain effective working relationships with coworkers, managers and clients; ability to work across geographies with awareness of cultural differences.

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.

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