Data Manager

**Summary of Duties and Responsibilities**:
The Odette Cancer Center (OCC) Clinical Research program is part of Sunnybrook Research Institute’s (SRI) ongoing commitment to participate in innovative and high quality clinical research.

Within OCC Clinical Research, the Quality Assurance and Education Manager, Operations Assistant Manager, and Budget & Operations Coordinator, work with 50+ physicians actively participating in clinical research and 50+ OCC clinical research disease site-specific staff. Our program is comprised of 10 disease site groups; Breast, CNS, GI, GU, Gynecology, Head & Neck, Hematology, Lung, Melanoma and Palliative; as well as 2 pan-Canadian initiatives (Personal My Treatment & The Canadian Cancer Clinical Trials Network (3CTN)).

The goal of this position is to assist the OCC Clinical Research Program as part of the Canadian Cancer Clinical Trials Network (3CTN). 3CTN is a pan-Canadian initiative to improve recruitment and the efficiency and quality of academic cancer clinical trials in Canada. At Sunnybrook, 3CTN funding supports the OCC Clinical Research program to promote and expand our academic, multicenter, interventional clinical trial activity on-site and in collaboration with other local hospitals. This position is for a regular full-time position. This position is entitled to health benefits plan, pension, and paid time off/sick days.

The 3CTN Data Manager will support the maintenance of 3CTN trials by completing responsibilities such as (but not limited to): coordination and maintenance of ongoing protocol requirements; conducting patient follow-ups, various hospitals and health service facilities to obtain medical information; data entry and resolving sponsor queries; conducting monitoring visits with external representatives, completing forms and maintaining supportive documentation; and requesting/processing specimens in laboratory.

In addition, the 3CTN Data Manager may support the Operations Assistant Manager with initiatives such as patient and public involvement projects and quarterly reporting to 3CTN. The 3CTN Data Manager may also support the Quality Assurance and Education Manager by assisting in quality assurance activities. The 3CTN Data Manager may also support trial maintenance-based trial activities at one of our affiliate hospitals which could require occasional travel to provide on-site support (Toronto-based hospital).

The 3CTN Data Manager will be working on-site Monday to Friday and will report to the 3CTN PI, while working closely with the interdisciplinary team.

**General responsibilities include, but are not limited to**:

- Data entry on electronic data capture systems (EDCs) and databases
- Internal tracking of trial-related data (patient visits, enrollment logs, etc)
- Resolving sponsor queries
- Preparing for and participating in remote and on-site monitoring visits
- Completing trial-related forms, maintaining trial master file documentation
- Communicating with patients, hospitals, and other health services to obtain medical information for study participants
- Assisting in collection of study data
- Preparing, processing, and safe shipment of blood, urine, tissue specimens
- Trial-related administrative tasks and other activities beyond what is listed on the posting as required by the trial team and as delegated by the Principal Investigator

**Qualifications/Skills**:

- Requires the successful minimum completion of a Community College Diploma/Certificate or University Degree in a health related discipline
- A minimum of 1-2 years of related professional or practical experience, in clinical research preferred, or the equivalent combination of education and professional experience
- Well-developed organizational and time management skills
- In-depth knowledge of ICH guidelines and Good Clinical Practice an asset
- Proven experience in processing and shipping blood samples
- Excellent team work and independent work habits with a strong “can-do” attitude
- Excellent oral and written communication skills
- Demonstrated accurate and efficient work habits with close attention to detail
- Strong analytical and problem solving skills
- Familiarity with medical terminology