Study Start Up Manager

IQVIA

. Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs .

Posted 5/2/2026full-timeToronto • 🇨🇦 CanadaSeniorLead💰 $103,000 - $153,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs
Oversee the execution of Site Activation 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 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
Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials
Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase
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
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

Requirements

What you’ll need

Bachelor's Degree Life sciences or related field
7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role
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

Comp & perks

Health insurance
Wellness programs
Other benefits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyregulatory submissionsregulatory compliancetechnical writingclinical trial managementproject managementdrug development processquality standardsclinical practice guidelinesregulatory intelligence

Soft Skills

negotiation skillscommunication skillsinterpersonal skillsteam playerleadership skillsorganizational skillsplanning skillspresentation skillsindependent judgmentrelationship management

Certifications

Bachelor's Degree in Life Sciences