4 часа назад
Clinical Trial Start-Up Specialist (Clinical Research)
63 000CAD
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Clinical Trial Start-Up Specialist (Clinical Research): Supporting the initiation of clinical trials and site activation across country-level programs with an accent on regulatory submissions, ICH-GCP compliance, and stakeholder coordination. Focus on managing amendments, aligning CROs and global teams, improving clinical trial systems, and implementing process automation.
Location: Mississauga, Ontario, Canada; hybrid work with a minimum of 3 days per week onsite.
Expected compensation: 63K annually. Final compensation depends on experience, skills, and qualifications.
Company
is an independent technology consulting firm providing business guidance and solutions through Information System & Digital, Telecom, Life Sciences, and Engineering services.
What you will do
- Develop and support country-level clinical trial start-up strategies.
- Coordinate site activation activities and manage timelines throughout trial initiation.
- Support regulatory submissions, amendments, and compliance with local requirements.
- Manage relationships with CROs, vendors, sites, Ethics Boards, Health Authorities, and institutional stakeholders.
- Collaborate with regional and global teams to harmonize clinical trial systems and processes.
- Identify and implement opportunities for automation, standardization, and continuous improvement.
Requirements
- Bachelor’s degree or higher in Life Sciences or a related field.
- 1–3 years of experience in clinical trial start-up, regulatory submissions, or related clinical research.
- Experience with site activation, regulatory submissions, CROs, vendors, and external stakeholders.
- Strong knowledge of ICH-GCP and applicable clinical trial regulations.
- Excellent written and spoken English; fluency in the written and spoken language(s) of the host country.
- Strong organizational, communication, interpersonal, and problem-solving skills, with willingness to travel when required.
Nice to have
- Postgraduate or Master’s degree in Clinical Research, Clinical Trials, Life Sciences, or a related field.
- Experience with Veeva Vault, CTIS, RIM, or similar clinical systems.
- Experience in a pharmaceutical, biotechnology, CRO, or clinical research environment.
- Experience with complex start-up activities, process improvement, automation, or standardization initiatives.
Culture & Benefits
- International community representing more than 110 nationalities.
- Internal Academy with more than 250 training modules.
- Opportunities to participate in internal events, including team-building activities.
- Inclusive environment focused on trust, professional development, and equal opportunities.
Hiring process
- Brief virtual or phone call followed by an average of three interviews.
- Role-specific case study or assessment may be required.
- Application feedback is provided within a maximum of 45 days from application or the most recent interview stage.
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