About AbbVie AbbVie’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 people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 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 98% of our employees are proud to say they work for AbbVie and 96% are proud of how we contribute to the community. AbbVie’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 people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’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 Senior 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 Ontario 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 learned” 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. Qualifications Education / Experience required: Bachelor’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 three 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 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 driver’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. Travel Yes, 50 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.