Your New Company! At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences. About The Role The Associate Study Manager will assist with planning and coordinating clinical trials and will work to execute clinical trials. Responsibilities of the Associate Study Manager include review of clinical trial documentation, resolution of queries and execution of task performed/clinical activities in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs). What You’ll Do Here Ensure the confidentiality of clinical trial participants and sponsors is respected. Maintain or assist in the maintenance of clinical trial source. This may include but is not limited to: preparation, filing, over-seeing updates and archival of trial related source. Review of subject eligibility for participation. Assist with the over-site and coordination of trial related activities. Perform protocol specific activities in accordance to training completion record. Record adverse events and concomitant medication use and follow-up on open adverse events until resolution. Obtain and document study related events and data in compliance with GCP/SOPs. Preparation and/or generation of trial related reports including but not limited to, deviation reports, sample inventory reports, briefing sheet. Ensure that data queries are resolved in a timely manner. Track enrollment status and appropriately document enrollment changes. Work with study monitors. This may include but is in not limited to: communications with the monitor, providing study source, responding to monitor queries and coordinating monitor visits. Provide assistance for specific tasks delegated by the Study Management team. This may include but is not limited to: protocol and ICF revisions, communications with other departments on trial progress and staffing design. Assist in protocol and ICF reviews. What You’ll Need to Succeed High School diploma required; college degree and related job experience preferred. Excellent written and verbal communication French and English. Leadership and organizational skills. Customer service focused, able to work in a fast-paced environment. Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Associate Study Manager including, but not limited to, for the following reasons: The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies. What We Offer: Full time position 37.5 hour/weeks Needs to be available to work flexible work hours when studies are ongoing including some weekends. On site position at our Montreal site (1200 Beaumont) Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work. Altasciences’ Benefits Package Includes: Health/Dental/Vision Insurance Plans RRSP with Employer Match Paid Vacation and Holidays Paid Sick and Bereavement Leave Employee Assistance & Telehealth Programs Altasciences’ Incentive Programs Include: Training & Development Programs Employee Referral Bonus Program Annual Performance Reviews MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!
