Job Description

Joining AbbVie means, you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada whereby 92% of our employees are proud to say they work for AbbVie.

AbbVieaEUR(TM)s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peopleaEUR(TM)s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womenaEUR(TM)s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

When choosing your career path, choose to be remarkable.

We have an opportunity for a Clinical Research Associate to join our Clinical Operations R&D team. The Senior Clinical Research Associate manages and monitors clinical studies and study sites in accordance with all relevant processes and procedures, as well as applicable regulations, ensuring delivery of data within the agreed parameters (quality/time).

This position is based in Quebec and reports to the Clinical Operations Manager.

Key responsibilities:

• For assigned sites/study(s) ensure successful protocol execution of SMM deliverables involving start-up, execution and closeout.
• Ensure site-related study, including but not limited to monitoring visits, site evaluations, site selection and activation, are executed accordingly, and monitoring closeout and visits are properly reported.
• Anticipate and identify site issues that could affect timelines and develop alternative solutions.
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current.
• Provide local regulatory and legal requirements. Ensures timely payment for the assigned sites/study(s) are fulfilled according to the clinical study agreements, and as per local requirements.
• Ensure adherence to best clinical practices, ICH guidelines, AbbVie standard operating procedures, monitoring plans and quality standards in conducting clinical research.
• Stay abreast of new and/or evolving local regulations, guidelines and policies
• Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities as per best clinical practice requirements.
• Prepare and follow-up site audits/inspections; provide input into the CAPA preparation.
• Responsible for coaching and mentoring clinical research associates, and providing input into their development.
• May be asked to be the point of contact for an assigned study. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by the manager.
• Provide consistent best practice approach to on-boarding, consolidating "lessons learnedaEUR across areas, and monitoring and define training materials and curriculum to ensure effective training is delivered in a timely manner.
• If assigned; may serve as the key point of contact in the country for assigned study. Country-level planning of timelines, LSR assignments, etc.
• If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives.
• Provides feedback on investigators/sites on an on-going basis.
• Interact and build professional and collaborative relationships with peers and site monitors.

Education / Experience required:

• BacheloraAEURA(TM)s degree in Science, related health field (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
• Solid knowledge of the biotech/pharmaceutical industry:
• Site Monitoring experience including (minimum of two years)
• All aspects of study monitoring; data, drug accountability, documentation experience.
• Ability to think and plan strategically (work plans, activities, timetables, targeting) and operating with execution excellence.

Essential skills and abilities:

• Advanced English and French language proficiency (oral and written).
• Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.)
• Must be at ease with technology (the use of various tools/systems to perform day-to-day tasks).
• Travel required at least 50% of the time.
• Valid driveraAEURA(TM)s license and passport.

Key leadership competencies:

• Demonstrate passion, curiosity, autonomy and flexibility.
• Operate and communicate effectively in a Matrix environment.
• Prepare and deliver effective storyline presentations.
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision-making.
• Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.
• Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
• Self-motivated and autonomous.

AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.

Covid vaccination new hires amendments:

Full vaccination against COVID-19 is a condition of employment for this position, with possible accommodation fora, validateda, exemptions, within the limits of applicable legislation. AbbVie employees are also required to comply with any COVID-19 related external requirements, including any testing requirements, applicable to their work activities outside AbbVie premises (for example, travelling and visiting stakeholders and customers).

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the companyaAEURA(TM)s affirmative action plan or policy statement, please email .

Travel: Yes, 50 % of the Time

Job Type: Temporary Work

Schedule: Full-time