Study Manager

Overview Join to apply for the Study Manager role at Altasciences. Altasciences focuses on the discovery, development and manufacturing of new drug therapies to bring them to people faster. We value Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, and foster a passionate and collaborative work environment. We are looking for talented and enthusiastic people to join our growing team. About The Role The Study Manager is responsible for the overall supervision, coordination and management of assigned clinical trials 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. Supervise and/or oversee all study related procedures. Act as a resource to indirect reports as well Clinical Operations team members. Oversee trial progression and communications in regard to the trial’s progression to clients, internal departments, etc. Participate in protocol and ICF reviews. Coordinate operations to meet protocol requirements and pre-defined study timelines. Pro-actively define any needs required to accomplish timelines. Ensure the creation of study specific SOPs, trainings or other materials as needed for study specific procedures. Conduct protocol trainings and/or coordinate any required training(s) on study specific procedures. Ensure On-site file(s) are complete and accurate. Approve staffing designs and review staffing schedules to ensure sufficient staffing requirements are met based on protocol needs. Assure the study Investigational Product (IP) is received and dispensed in lieu with study timeline requirements. Participate in SOP revisions. Prepare for, participate in and/or act as a liaison for audits conducted by study sponsors, Quality Assurance (QA) and regulatory agencies. Coordinate study monitoring. This may include but is not limited to: communications with the monitor, providing study source, responding to monitor queries and coordinating monitor visits. Perform protocol specific activities. 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. Track enrollment status and appropriate document enrollment changes. Review of subject eligibility for participation. What You’ll Need To Succeed DEC or higher-level degree in sciences or related field Minimum 2 years’ experience in a GxP research environment/CRO; Excellent written and verbal communication (French and English) Leadership and organizational skills. Customer service focused, able to work in a fast-paced environment. Flexible work hours when studies are ongoing including some weekends. Language and Francisation 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 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. The employee communicates frequently with Altasciences employees across Canada and the United States. As such, English is the main language used to correspond between offices. The employee frequently communicates with English-only customers outside the province of Quebec. Benefits Health/Dental/Vision Insurance Plans RRSP with Employer Match Paid Vacation and Holidays Paid Sick and Bereavement Leave Employee Assistance & Telehealth Programs Incentives Training & Development Programs Employee Referral Bonus Program Annual Performance Reviews Referrals increase your chances of interviewing at Altasciences by 2x. Job Details Seniority level: Entry level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Research Services #J-18808-Ljbffr