Be an early applicantLess than 25 applicants

Company

IQVIA · 11 hours ago

Sponsor Dedicated - Site Activation Manager

Durham, NC

Full-time

Remote

Mid, Senior Level

$90K/yr - $149K/yr

5+ years exp

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AnalyticsHealth Care

H1B Sponsor Likely

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Responsibilities

Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.

Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.

Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.

Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.

Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.

Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.

Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.

Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.

Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.

Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.

Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).

Mentor and coach colleagues as required.

Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.

May take a lead role in developing long standing relationships with preferred IQVIA customers.

Deliver presentations/training to clients, colleagues and professional bodies, as required.

May be involved in activities related to monthly study budget planning and reviews.

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 experienceRegulated clinical trial knowledgeDrug development process knowledgeGCP guidelines knowledgeICH guidelines knowledgeFinancial management knowledgeTechnical writing skillsProject management skills

Required

Bachelor's Degree Life sciences or related field

5 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.

Strong negotiation and communication skills with ability to challenge

Excellent interpersonal skills and strong team player

Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects

Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process

Demonstrated proficiency in using systems and technology to achieve work objectives

Good regulatory and/or technical writing skills

Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines

Good leadership skills, with ability to motivate, coach and mentor

Good organizational and planning skills

Ability to exercise independent judgment taking calculated risks when making decisions

Good presentation skills

Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

Excellent understanding of study financial management

Proven ability to work on multiple projects balancing competing priorities

Benefits

Incentive plans

Bonuses

Other forms of compensation

A range of 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

10001+ employees

https://www.iqvia.com

H1B Sponsorship

IQVIA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (218)

2022 (199)

2021 (286)

2020 (197)