Lead Clinical Data Manager H/F

2 weeks ago

Canada Medrio Inc. Full time $90,000 - $105,000

Job Summary :

The Lead Clinical Data Manager (LCDM) is to be the subject matter expert pertaining to eCRF design, data management guidelines, and database creation.

The LCDM will be responsible for all clinical data management activities in compliance with Standard Operating Procedures (SOPs) and current industry/regulatory guidelines.

Coordinate deliverables on assigned projects depending on the relevant model and Data Management (DM) Vendor. Serves as the first line of contact at the project level.

Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop Data Management Plans that will deliver accurate, timely, consistent, and quality clinical trial data.

Independently perform all activities related to data management per regulations and applicable standard operating procedures (SOPs).

Primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.

Primary contact person for communication and discussion of topics related to data management timelines and deliverables, request for out of scope tasks, and first line contact for technical or procedural issues.

Responsible for planning and implementing data management timelines and deliverables, for providing database and data management activities status reports, and contributes to the overall project planning, progress tracking and reporting.

Develop and maintain data validation specifications.
Fully involved in the clinical study database User Acceptance Testing (UAT), and ensure proper documentation thereof.
Manage the process of database modifications (after go-live) due to protocol amendments or study needs.

Regularly communicate and/or respond to data collection sites, third party service providers, and when appropriate sponsors; responding to queries in a timely manner, addressing data collection and/or quality issues effectively ensuring customer expectations are managed appropriately and data-related communications/updates remain current and relevant.

Perform third party non-eCRF data management activities, including data transfers and Serious Adverse Event (SAE) reconciliation.
Work collaboratively with the other departments within Medrio to meet project deliverables and timelines for clinical data management.
Cooperate and assist the Quality Systems department with quality control audits on assigned databases.
Perform database soft-lock and hard-lock activities.

A minimum of 5 years of clinical data management related experience in either a CRO, pharmaceutical, biotech, or device company.

Remote

In-depth understanding of database structures and database programming.
In-depth knowledge of clinical trial processes and experience in ICH, GCP, and GCDMP (SCDM).
Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A.
Strong analytical, problem solving, and technical skills in database programming.

Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.

Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
Knowledge of at least one computer programming language is an asset.

At Medrio, we look for smart, capable, and conscientious people to help us expand our product capabilities, grow our business, and better serve our customers.

Our employees love working for us because they get to develop, market, and sell a product that advances human health, and they enjoy many perks, including:

~25 Days Holiday + Bank Holidays
~ Pension
~ Private medical cover

The Medrio team is made up of individuals with a wide array of skills and interests, but all have a passion for providing the best possible user experience for our customers

Salary Range:
$90, ,000 CAD

To see detailed information on the data we collect during the application process, and how Medrio complies with data privacy laws, visit our Careers page.

Will you now or in the future require visa sponsorship?

How many years of Clinical Data Management experience do you have?
For government reporting purposes, we ask candidates to respond to the below self-identification survey.

As set forth in Medrio 's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.

or a person who was discharged or released from active duty because of a service-connected disability.
S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order
Voluntary Self-Identification of Disability
OMB Control Number
For government reporting purposes, we ask candidates to respond to the below self-identification survey.

As set forth in Medrio 's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.

or a person who was discharged or released from active duty because of a service-connected disability.
S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order
Veteran Status Please select Veteran Status Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number Expires 04/30/2026
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one.

If you want to learn more about the law or this form, visit the U.Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at .

How do you know if you have a disability? A disability is a condition that substantially limits one or more of your "major life activities." If you have or have ever had such a condition, you are a person with a disability.


Disabilities include, but are not limited to:
Intellectual or developmental disability
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Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
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