Job description
We are looking for a Clinical Trial Start-Up Specialist to support the efficient and compliant initiation of clinical trials. This role will be responsible for developing and implementing country-level start-up strategies, overseeing site activation activities, supporting regulatory submissions, and driving process improvements throughout the clinical trial lifecycle.
The successful candidate will work closely with regional and global teams, external stakeholders, CROs, vendors, Ethics Boards, and Health Authorities to ensure clinical trials are initiated efficiently, within timelines, and in compliance with applicable regulations.
Location
Mississauga, Ontario, Canada
Work Mode
Hybrid – Minimum 3 days per week onsite
Key Responsibilities
- Lead and support country-level clinical trial start-up strategies.
- Coordinate and oversee start-up activities to ensure timely site activation.
- Support regulatory submissions and ensure compliance with applicable local requirements.
- Manage amendments throughout the clinical trial lifecycle.
- Collaborate with regional and global teams to align strategies, systems, and timelines.
- Manage relationships with CROs, vendors, sites, and other external stakeholders.
- Identify opportunities for process automation, standardization, and continuous improvement.
- Support the harmonization of clinical trial systems and processes.
- Collaborate with Ethics Boards, Health Authorities, government bodies, and institutional stakeholders when required.
- Contribute to external industry collaborations and initiatives related to clinical trial start-up.
- Ensure adherence to ICH-GCP, EU CTR, and applicable local regulatory requirements.
- Manage multiple priorities in a fast-paced, matrixed, and global environment.
Required Qualifications
- Bachelor's degree or higher in Life Sciences or a related field (MD, PhD, MA/MS, BA/BS, or equivalent).
- 1–3 years of experience in clinical trial start-up, regulatory submissions, or related clinical research activities.
- Demonstrated experience supporting clinical trial start-up and site activation.
- Experience with regulatory submissions and understanding of local regulatory requirements.
- Strong knowledge of ICH-GCP and applicable clinical trial regulations.
- Experience managing relationships with sites, CROs, vendors, and external stakeholders.
- Strong communication, interpersonal, organizational, and problem-solving skills.
- Ability to work effectively within cross-functional, matrixed, and global teams.
- Excellent written and spoken English.
- Fluency in the written and spoken language(s) of the host country.
- Strong attention to detail and ability to manage multiple priorities.
- Willingness and ability to travel when required.
Preferred Qualifications
- Postgraduate or Master's degree in Clinical Research, Clinical Trials, Life Sciences, or a related field.
- Experience with clinical systems such as Veeva Vault, CTIS, RIM, or similar platforms.
- Experience managing complex clinical trial start-up activities.
- Previous experience collaborating with Ethics Boards, Health Authorities, or government/institutional bodies.
- Experience identifying and implementing process improvements, automation, or standardization initiatives.
- Experience working in a global pharmaceutical, biotechnology, CRO, or clinical research environment.
Key Skills
- Clinical Trial Start-Up
- Regulatory Submissions
- Site Activation
- ICH-GCP
- Clinical Research
- CRO & Vendor Management
- Stakeholder Management
- Clinical Trial Systems
- Process Improvement
- Cross-functional Collaboration
- Problem Solving
- Organizational Skills
Expected Compensation Range:
63K. The final compensation offered will be determined based on the candidate’s level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements.
Canadian Experience Requirement:
No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.
Artificial Intelligence (AI) Disclosure:
No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.
Statement Regarding Job Vacancy:
This position is an existing vacancy/Job creation, created to support ongoing project needs.
Recruitment Process & Feedback Timeline:
Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.
Why choose us
- An international community bringing together more than 110 different nationalities
- An environment where trust is central: 70% of our leaders started their careers at the entry level
- A strong training system with our internal Academy and more than 250 modules available
- A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)
Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!