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
• High School diploma or GED and related job experience required, college degree preferred.
• Excellent written and verbal communication (French and English at the Montreal location), leadership and organizational skills.
• Customer service focused, able to work in a fast-paced environment.
What We Offer:
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
401(k)/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 Review
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Skills Required
- High school diploma or GED
- Related job experience
- Excellent written and verbal communication skills
- French and English fluency for the Montreal location
- Leadership skills
- Organizational skills
- Customer service focus
- Ability to work in a fast-paced environment
- College degree
What We Do
Outsourcing made easy with a one-stop solution to early-phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!
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