Clinical Study Manager

5 months ago

Montréal, Canada Altasciences Full time

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.

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 oversee all study related procedures.
- Act as a resource to indirect reports as well Clinical Operations team members.
- Oversee trial progression and communications regarding 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, training or other materials as needed for study specific procedures.
- Conduct protocol training 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 in 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.

**What you need to succeed**:

- DEC or higher-level degree in sciences or related field;
- Minimum 2 years’ experience in within 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.

What We Offer
Permanent position, full-time;
**Full time**: 37.5 hours of work over 5 days per week;
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

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