Altasciences

Manager

• Provide leadership and direction to DM project leads, data managers, and support staff across multiple clinical trials and therapeutic areas
• Serve as the primary DM point of contact for key sponsor accounts, ensuring client satisfaction and project success
• Oversee resource allocation, project timelines, and budgets within the DM function
• Mentor, coach, and develop DM staff, fostering a culture of quality, accountability, and continuous improvement
• Lead the planning, execution, and delivery of all DM activities for assigned studies
• Ensure adherence to company SOPs, GCP, ICH, and regulatory requirements
• Collaborate with Biostatistics, Programming, and Clinical Operations to ensure data readiness for interim analyses and final submissions
• Develop, implement, and enhance DM processes, standards, and tools to drive consistency and efficiency across studies
• Build and maintain strong relationships with sponsor data management and clinical teams

Senior Manager, Data Management

Compliance

• Preparing, reviewing and submitting CTAs for small molecules, biologics and natural health products to Health Canada's Directorates (TPD, BGTD, NHPD)
• Company contact and regulatory liaison with Health Canada
• Analyses the information provided by the sponsor and prepares a complete file showing the relevant information to the regulatory body
• Oversight and/or preparation of all responses to all Health Canada clarifications requests
• Performs the needed follow-ups to insure that the regulatory requirements needed to start a study are met
• Maintenance of submission (CTA-A, notification, cancellation)
• Responsible for assigned study submissions to the IRB, including interactions, answering to clarifications when needed, and ensuring IRB requirements are met prior to protocol implementation
• Preparing and submitting exemption application for controlled substances
• Maintains a database for regulatory submissions and related questions
• Responsible for submission/maintenance of annual clinical documents to IRB
• May provide regulatory support for drugs, biological products, medical devices, 505b2 program, IND requirements and regulatory documentation (such as CTD/NeeS/eCTD format requirements)
• May participates to drug development files to be submitted to the regulatory bodies (ex.: pre-IND, IND, pre-CTA)
• May communicates with Health Canada to insure the feasibility and filling requirements of clinic trials requests on the regulatory level
• Maintain current awareness on regulatory guidelines (such as Health Canada's TPD, NHPD, and BGTD, FDA) and ensure processes are adjusted as necessary
• Undertake continuous learning and development on regulations through self-training, workshops and conferences
• Present details of workshops/courses attended or new knowledge acquired
• Prioritize own work and manage project schedule to meet delivery deadlines
• Represents Algorithme Pharma in scientific meetings/exhibitions or business meetings

Regulatory Affairs Associate

Program Manager

• Manages relationships with internal and external stakeholders.
• Supports logistics and drives timelines and communication to ensure successful execution of IND-enabling packages and nonclinical portfolios for our Sponsors.
• Oversees nonclinical study packages or portfolios from award to completion.
• Plans and facilitates internal and external kick off meetings and ongoing team meetings.
• Uses interpersonal skills to liaise between teams to ensure requirements, scope and milestones are understood and met.
• Serves as an advocate for the Sponsor and communicates Sponsor expectations.
• Contributes to contingency planning for key resources and activities.
• Develops and maintains appropriate tools to provide regular updates to stakeholders.
• Works closely with Business Development and senior members of the Program Management team.

Scientific Program Manager

Administrative Assistant

• The Temporary Clerical Assistants will support our electronic filing project.
• In this role, you will be responsible for organizing, digitizing, and accurately entering documents into our electronic records management system.
• This is an excellent opportunity for individuals with strong organizational skills who enjoy working in a structured environment.
• What You'll Do Here: Review and organize electronic documents filing.
• Upload files to the appropriate electronic folders and databases
• Verify the accuracy and completeness of electronic records
• Maintain confidentiality and follow company data-handling protocols
• Collaborate with team members to ensure project deadlines are met

Senior Manager, Data Management

Regulatory Affairs Associate

Scientific Program Manager

Administrative Assistant (AS)