Associate Study Start-Up Manager - IQVIA Biotech (Homebased)

Lifelancer; Kirkland; Híbrido; CAD 90.000 - 120.000; Jornada completa

Descripción de la vacante

IQVIA is seeking an Associate Study Start-Up Manager to Direct and manage site activation, maintenance and regulatory activities for clinical studies. This remote role in Canada requires leading cross-regional efforts, ensuring compliance with regulatory requirements and delivering on timelines.

The successful candidate will guide regulatory strategy, draft essential documents, and mentor team members while coordinating with stakeholders across regions and countries.

Formación

• Bachelor's degree in life sciences or related field required.
• 7+ years of experience in scientific or clinical environment, including international exposure.
• Equivalent combination of education, training and experience acceptable.
• Strong negotiation and communication skills; ability to influence stakeholders.
• Excellent interpersonal skills and teamwork abilities.
• Thorough understanding of regulated clinical trials and drug development.

Responsabilidades

• Oversee site activation and maintenance activities per RSU strategy and project timelines.
• Develop and maintain Management Plan within scope of work and project plan.
• Coordinate regulatory strategy and submissions across regions and countries.
• Prepare and review technical/administrative docs to support study initiation and maintenance.
• Provide regulatory and scientific support to enable efficient trial initiation and maintenance.

Conocimientos

Regulatory strategy

Cross-functional leadership

Communication skills

GCP/ICH knowledge

Mentoring

Project coordination

Educación

Bachelor's Degree Life sciences

Herramientas

CTMS

Descripción del empleo

Job Title: Associate Study Start-Up Manager - IQVIA Biotech (Homebased) Job Location: Kirkland, Quebec, Canada Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions

• 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.

Qualifications

• Bachelor's Degree Life sciences or related field
• Req 7 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

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 IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. IQVIA is committed to integrity in our hiring process and ma