Cgen Clinical Data Manager

2 weeks ago

Toronto, Canada SickKids Full time

**About SickKids**:
Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and education. Our reputation would not have been built - nor could it be maintained - without the skills, knowledge and experience of the extraordinary people who come to work here every day. SickKids is committed to ongoing learning and development, and features a caring and supportive work environment that combines exceptionally high standards of practice.

When you join SickKids, you become part of our community. We share a commitment and determination to fulfill our vision of _Healthier Children. A Better World_.

Don’t miss out on the opportunity to work alongside the world’s best in paediatric healthcare.

**Position Description**:
CGEn, funded by the Canada Foundation of Innovation (CFI) and leveraging investments from Genome Canada and other stakeholders, is a genomics network with linked-laboratories in Toronto, Montreal and Vancouver, and users and collaborators spanning all of Canada, and internationally. CGEn’s mission is to enable Canadian leadership in fundamental and applied genome science research, most notably through the genome-wide sequencing of RNA and DNA, epigenomics and metagenomics in humans and other species, as well as all aspects of managing and analyzing the complex datasets generated.

The primary role of the CGEn Clinical Data Manager is to lead clinical research activities relating to genomic and clinical database development, project implementation, maintenance, reporting and access at CGEn. These activities include but are not limited to data management planning, designing case report forms, designing and monitoring databases, monitoring data flow, quality control and access processes. The position reports to the CGEn Director, Partnerships & Programs and works closely with the CGEn Central Team as well as institutional partners.

**Here’s What You’ll Get To Do**:

- Collaborate with institutional partners to create, execute and adapt clinical and genomic data management plans and processes for collection, reporting, analysis and access.
- Participate in the development of data collection standards, lead case report form designs and ethics documentation as well as liaise with research ethics boards for submissions, amendments and renewals
- Keep abreast of regulations and policies governing clinical research.
- Assist in recruitment of study sites, supervise study initiations and the collection of study data; lead study-specific start-up tasks, including managing execution of agreements, compliance and regulatory documents and process improvements, as needed.
- Supervise and monitor contributing study sites (timelines, compliance, training, eligibility, quality assurance); liaise with project teams and other stakeholders to support study participation and respond to queries.
- Supervise data collection from participating sites, perform data validation, entry, collaboratively address data collection and/or quality issues, maintain database records and prepare study results, as needed.
- Regularly review quality of data output ensuring all data created meets integrity, quality, validity, and reliability standards and is collected, compiled, tested, and reported on in accordance with relevant guidelines, industry best practices and regulatory standards.
- Perform various complex tasks to ensure complete, accurate, high quality, and regulatory compliant data supporting publications, promotional materials and other requirements.

**Here’s What You’ll Need**:

- Certification as a Clinical Research Professional (CCRP).
- Developing and understanding of clinical trial protocols and processes, including data privacy guidelines and regulations, for the purpose of case report form/questionnaire design and end-to-end data flow.
- Understanding of research ethics board requirements and processes; thorough knowledge of and experience in clinical data operations.
- Effective verbal and written communication, influencing, and partnering skills to interact with personnel, projects and partners at all levels; ability to solve complex problems. Demonstrating proactive drive and sound decision-making.
- Demonstrated strong analytical, organizational and time management skills; efficient work habits with close attention to detail.
- Experience in the management of multi-centre study is an asset.

**Our Commitment to Diversity**:
The children and families we care for are from a variety of communities, and so are our employees. We welcome and encourage everyone to join our organization and be part of our team.

Thank you for your interest in joining SickKids. Only those applicants selected for an interview will be contacted. In accordance wi

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