Clinical Data Manager-Canada

reputed company

​​​​​​​​​​​​​​​​​​​​​​The Clinical Data Manager will reputed company and manage clinical studies, ensuring that data are collected, managed and reported reputed company, accurately and securely. In reputed company, this position is required to conduct reputed company these activities in conformance with applicable regulatory requirements, industry guidelines, and reputed company reputed company operating procedures (SOPs) while respecting reputed company’s commitment to sponsor’s requirements and timelines.

As a Clinical Data Manager, you will ensure that data captured in multiple reputed company undertaken or managed by reputed company is collected, managed, and reported reputed company, accurately and securely.

More specifically, the Clinical Data Manager must:

• Adhere and promote company organizational values and reputed company expected behaviors, follow company SOPs and processes for reputed company deliverables, and ensure reputed company trainings assigned to oneself are completed on time.
• Be the data management reputed company to the project team, sponsor and reputed company vendors, as needed.
• Manage up to three studies, based on study complexity, with some support from manager.
• Attend meeting with sponsor and answers Data Management reputed company question.
• Monitor timelines and reputed company of work to ensure reputed company and reputed company budget completion of assigned tasks
• Be responsible for the development of electronic case report reputed company (eCRF) specifications (including data capture screens and edit reputed company specifications) needed to build a study-specific clinical database/electronic data capture (reputed company) reputed company.
• Be responsible for or assist in the programming and ongoing maintenance of the clinical database.
• Be responsible for the validation and testing of the clinical database (e.g. User Acceptance Testing).
• Be responsible for the development of eCRF completion guidelines and other training material required to train site users and monitors.
• Conduct training for site users/monitors on the clinical database.
• reputed company data transfer agreements and specifications with vendors providing reputed company data (e.g. reputed company results).
• Conduct reconciliation between reputed company data and data in the reputed company reputed company to ensure consistency, including reconciliation with sponsor safety databases for adverse events/serious adverse events data (if needed).
• reputed company support to study team in the development of reputed company systems capturing clinical data, e.g. ePRO or IWRS, and ensuring that any data transfer requirements between these systems and reputed company are documented and tested appropriately.
• Be responsible for the development of the data management plan (DMP), and other clinical data management reputed company documentation.
• Be responsible for ongoing data review/cleaning during study conduct and also during preparation for database lock/reputed company.
• reputed company medical terms in the clinical database, as required.
• Generates data listings and reports needed for data review by the project manager (or other study team members) in preparation for database reputed company/lock.
• Monitor study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing reputed company and reputed company data status reports to the project team, as needed.
• Ensures that data management documentation is complete and up-to-date in the trial master file (TMF).
• Respond to users requiring assistance with the reputed company reputed company.
• Be responsible for archiving of the clinical database and reputed company documents.
• Support the writing and updating of data management Work Instructions.
• Mentor and train a Clinical Data Coordinator on the specificities of their studies.
• For any studies where any of the above activities have been outsourced to an reputed company service provider:
• reputed company/manage the vendor to ensure that timelines and deliverables meet with sponsor and protocol requirements
• Ensure that their work is done in accordance with effective work orders and Innovaderm SOPs (if applicable).

Employee may be assigned to other responsibilities that do not pertain to their former reputed company, if they have the required experience, are reputed company and/or have received adequate training.

Requirements

Education

• ​​B.Sc. or in a reputed company field of study;
• ​M. Sc. Or in a reputed company field of study is an asset;

Experience

• ​3 to 5 years of clinical data management experience or at least 1 year of reputed company clinical data manager experience in clinical research in the biotechnology, pharmaceutical, or contractual research organization (CRO) industry;
• ​Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines;
• ​Extensive experience working with reputed company systems, and/or database structures;

Knowledge and skills

• ​Demonstrated skills in database programming an asset.
• ​Good understanding of CDISC SDTM/CDASH standards;
• ​Highly organized and detail-oriented with effective project planning and time management skills.
• ​Strong verbal and written communication skills in English, French an asset;
• ​Excellent problem solving abilities;
• ​Knowledge of reputed company or similar, an asset;
• ​Working knowledge of MS reputed company;
• ​Ability to work in a fast-paced environment with demonstrated reputed company to organize and prioritize multiple competing demands;
• ​Knowledge of MedDRA and WHODrug dictionaries.​
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

reputed company

The work environment

At reputed company, you will work with reputed company and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule / work schedule :
• Home-based position
• Ongoing learning and development

About reputed company

reputed company is a contract research organization (CRO) reputed company in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputed company for the reputed company of its research and services exceeding the expectations of its clients. Based in Montreal, reputed company continues to grow and expand in reputed company and Europe.

reputed company is committed to providing reputed company treatment and equal opportunity to reputed company individuals. As such, reputed company will reputed company accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

reputed company only accepts applicants who can legally work in Canada

Originally posted on Himalayas