Clinical Operations Specialist

JOB DESCRIPTION:

Title: Clinical Operations Specialist
Location: Montreal, QC / Hybrid
Commitment: Full-Time (1 year contract with possibility to extend)
Compensation: Market Competitive
Apply By: Sept 1, 2023
Start Date: ASAP

HOW TO APPLY:

To apply, please send an email to [email protected]. Please include the title of the position you are applying to in the subject line and attach your resume.

DESCRIPTION:

Founded in 2019 with headquarters in Montreal, QC, FemTherapeutics Inc. is a medical device company with a mission to personalize medicine for women. We have developed a data and intelligence platform that leverages AI, cloud software, and 3D printing to produce patient-specific gynecological prosthetics for the non-invasive treatment of pelvic health conditions. Our first product is indicated to manage the symptoms of Pelvic Organ Prolapse and Stress Urinary Incontinence.

As FemTherapeutics works towards market launch in early 2024, the team is currently looking for a motivated Clinical Operations Specialist that is keen to learn, grow and develop clinician/patient focused tech. We are looking for analytical individuals that can take the lead on preparing clinical publications, developing clinical protocols, managing clinical sites from site selection to closure, and maintaining communication with patients and clinicians. This is an opportunity to join a growing Montreal start-up working with cutting-edge technology to modernize treatments for women’s health. This is a hybrid role with a few days in-person at our offices in downtown Montreal.

RESPONSIBILITIES:

Collaborate on the strategic planning and execution of clinical publications
Conduct primary and secondary research to inform product specs by conducting surveys, focus groups, patent searches, literature reviews, and more while staying up to date on the latest developments and trends to inform our clinical operations strategy
Cultivate and nurture strong relationships with patients, physicians, and clinical sites, actively expanding our network and fostering collaborative partnerships
Host and participate in scientific advisory discussions with medical professionals
Assist in clinical trial planning by proactively liaising with clinical sites, contributing to the development of comprehensive clinical protocols, and overseeing the clinical trials.
Provide crucial support in preparing regulatory submissions to regulatory bodies, including the FDA and Health Canada
Assist in the formulation of biocompatibility testing plans, leveraging your expertise to contribute to the development of safe and effective medical devices

EDUCATION & EXPERIENCE:

Must hold a Bachelors or Masters in life sciences, health related fields or equivalent with research experience
Minimum of 2 years work/research experience in an academic, medical, or CRO environment
Strong verbal and written communication skills with the ability to understand and summarize medical terminology
Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data
Excellent interpersonal and teamwork skills
Strong computing skills in MS Office applications (preferred)
Ability to write and communicate in French
Ability to travel within Canada and the US

HIRING PROCESS:

If we interview you, you can expect these milestones. The entire process will take 2 weeks.
You meet the hiring manager for the role
You complete two calls with other team members
We speak with two references you provide
We make an offer

BENEFITS:

All full-time employees enjoy:
Health plan benefits
ESOP participation
Spa, gym, and other benefits

FemTherapeutics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected.