Clinical Data Manager

WEP Clinical; Montreal; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading clinical research organization in Montreal is seeking a Clinical Data Manager to oversee data management for clinical trials. Responsibilities include ensuring compliance with regulatory guidelines, managing clinical databases, and collaborating with clients to enhance data strategies. Candidates should have a Bachelor's degree and experience in clinical research. The role offers comprehensive benefits, including medical insurance and paid leave.

Benefits

Medical, dental, and vision insurance

401K with company match

Paid vacation, holiday, and sick time

Qualifications

• Must have a Bachelor's Degree in a related field.
• Experience in clinical research, preferably with pharmaceutical or medical device companies.
• Proficiency in MS Office suite and data capture systems.

Responsibilities

• Lead data management activities for multiple clinical trials.
• Plan, develop, test, and validate clinical databases.
• Collaborate with clients on study design and data cleaning.

Skills

Knowledge of GCP and ICH guidelines

Experience in data review and cleaning

Effective communication skills

Leadership skills

Familiarity with statistics

Education

Bachelor’s Degree in a related field

Tools

MS Office suite

Data capture systems

Job description

Overview

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives

The WEP Clinical Data Manager leads and oversees the data management activities for multiple clinical trials, ensuring high-quality data and compliance with regulatory requirements. This role involves the management of the design, development, and validation of clinical databases, maintaining robust relationships with external vendors, and actively communicating with Sponsors. As a Clinical Data Manager, you will ensure that all data management processes adhere to regulatory guidelines and prepare the team for audits and inspections, while also engaging directly with customers to align data management strategies with client needs and expectations.

What You\'ll Do

• Lead comprehensive data management activities for multiple clinical trials, ensuring regulatory compliance and data quality.
• Plan, develop, test, and validate clinical databases and EDC systems to meet trial needs.
• Collaborate with clients and cross-functional teams on study design, eCRF design, and data cleaning.
• Monitor and ensure data quality, accuracy, and timely database entries from study sites.
• Manage external vendors to deliver quality services within project timelines.
• Maintain regular communication with clients to update on milestones and progress.
• Ensure adherence to GCP, ICH, and regulatory requirements, supporting audits and inspections.
• Proactively track study timelines, managing risks and deviations effectively.
• Contribute to process improvement by developing systems, SOPs, and guidance documents.
• Support business development activities, including preparing presentations and bid defense materials.

What You\'ll Need

• Bachelor’s Degree in a related field
• Knowledge of GCP and ICH guidelines.
• Experience in data review and cleaning activities
• Proficiency in MS Office suite and data capture systems.
• Experience in clinical research, preferably with pharmaceutical or medical device companies, hospitals or CROs.
• Familiarity with statistics, programming, and field monitoring
• Effective communication skills and leadership skills

What We Offer

• Medical, dental, and vision insurance, FSA, HSA
• Voluntary short-term and long-term disability insurance
• Voluntary life insurance
• 401K safe harbor plan and company match
• Paid vacation, holiday, and sick time
• Paid maternity & paternity leave

What Sets Us Apart

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

Company Details

Seniority level: Entry level

Employment type: Full-time

Job function: Research, Analyst, and Information Technology

Industry: Pharmaceutical Manufacturing

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