Clinical Data Manager-Canada

Indero•Montreal, QC

12h•Remote

About The Position

The Clinical Data Manager will lead and manage clinical studies, ensuring that data are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines. As a Senior Clinical Data Manager, you will ensure that data captured in multiple clinical trials undertaken or managed by Indero is collected, managed, and reported clearly, accurately and securely.

Requirements

B.Sc. or in a related field of study
3 to 5 years of clinical data management experience or at least 1 year of lead 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 EDC systems, and/or database structures
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 SAS or similar, an asset
Working knowledge of MS Excel
Ability to work in a fast-paced environment with demonstrated agility 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

Nice To Haves

M. Sc. Or in a related field of study is an asset

Responsibilities

Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.
Be the data management liaison to the project team, sponsor and external 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 related question.
Monitor timelines and scope of work to ensure timely and within budget completion of assigned tasks.
Be responsible for the development of electronic case report form (eCRF) specifications (including data capture screens and edit check specifications) needed to build a study-specific clinical database/electronic data capture (EDC) system.
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.
Develop data transfer agreements and specifications with vendors providing external data (e.g. laboratory results).
Conduct reconciliation between external data and data in the EDC system to ensure consistency, including reconciliation with sponsor safety databases for adverse events/serious adverse events data (if needed).
Provide support to study team in the development of external systems capturing clinical data, e.g. ePRO or IWRS, and ensuring that any data transfer requirements between these systems and EDC are documented and tested appropriately.
Be responsible for the development of the data management plan (DMP), and other clinical data management related documentation.
Be responsible for ongoing data review/cleaning during study conduct and also during preparation for database lock/close.
Code 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 close/lock.
Monitor study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provide 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 EDC system.
Be responsible for archiving of the clinical database and related 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 external service provider: Oversee/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 description, if they have the required experience, are qualified and/or have received adequate training.