Study Manager

• 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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