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Company

IQVIA · 23 hours ago

Trial Delivery Manager/Senior Trial Delivery Manager

Durham, NC

Full-time

Remote

Mid, Senior Level

$112K/yr - $187K/yr

5+ years exp

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H1B Sponsor Likely

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Responsibilities

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. 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 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 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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical research experienceClinical Practice (GCP)International Conference on Harmonization (ICH)Clinical trial knowledgeProtocol knowledgeTherapeutic knowledgeProject financesProject management knowledgeIQVIA Core CompetenciesResults-oriented approachCollaboration skillsCross-collaboration skills

Required

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

5-7 years clinical research/monitoring experience or equivalent combination of education, training and experience

Consolidated knowledge of Project management practices and terminology

Good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Broad protocol knowledge and therapeutic knowledge

Good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates

Understanding 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

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

Problem solving skills

Planning, time management and prioritization skills

Attention to detail and accuracy in work

Results-oriented approach to work delivery and output

Good influencing and negotiation skills

Good judgment and decision-making skills

Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues

Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint

Ability to establish and maintain effective working relationships with coworkers, managers and clients

Ability to work across geographies displaying a high awareness and understanding of cultural differences

Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership)

Benefits

Incentive plans

Bonuses

Health and welfare and/or other benefits

Company

IQVIA

Glassdoor

3.9

IQVIA provides analytics, compliance, and management solutions to the life sciences industry.

Founded in 1982

Danbury, Connecticut, USA

10,001+ employees

https://www.iqvia.com

H1B Sponsorship

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Trends of Total Sponsorships

2023 (218)

2022 (199)

2021 (286)

2020 (197)