Careers

I. JOB SUMMARY
The Clinical Data Manager I (CDM I) oversees and performs data management on single and/or multicentre studies, ensuring accuracy of clinical trial data and compliance with the study protocol, GCP, and regulatory requirements. The CDM I is an integral part of the study team and collaborates with CTS/CTM, CRM, SM, sponsor and sites as needed to address data related issues.

II. QUALIFICATIONS
• At minimum, completion of a Bachelor’s of Science degree or recognized equivalent
• Experience in some or all of data management, oncology, clinical trials, issues involving human subjects, preferred
• Experience with Medidata Rave, and/or REDCap (or equivalent EDC system)
• Good written and verbal communication skills, excellent organization, prioritization skills, excellent computer skills and the ability to learn quickly
• Ability to work under pressure and attention to detail
• Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to Ozmosis Research Inc. standards
• Possess good judgment with the ability to multi-task
• Ability to work well as part of a team
• Relevant knowledge of applicable legislation and regulations

III. KEY ACCOUNTABILITIES & RESPONSIBILITIES
The key accountabilities and responsibilities listed below that the Clinical Data Manager I is responsible for will vary according to each individual study agreement.

A. Data Management

-The Clinical Data Manager I will perform data management for their respective trials ensuring data is captured appropriately and in accordance with the study protocol, Data Management Plan and established Ozmosis Research standard operating procedures/guidelines.
-Reviewing data, either through manual review of eCRFs or via data listing review and issuing queries where required to clarify and correct any incorrect, missing, or otherwise inadequate/discrepant data.
-Providing data and reports as needed for phase I safety cohort reviews, DSMB meetings, and ad hoc sponsor requests.
-Responsible for maintaining systems and tools for effective data flow and cleaning.
-Coordinating with the CTS/CTM in resolving queries from sites and sponsors, where applicable.
-Regular communication with CTS/CTM, study team and Senior Management on data cleaning progress and metrics.
-Liase with the CTS/CTM on the development and maintenance of all study data management trackers and guidelines, including the Data Management Plan.
-Overseeing database lock and data transfer process.
-Collaborating with the study team as required for statistical analysis.

B. Database Development

-Depending on business needs, the CDM I may also be responsible for the development, maintenance, and implementation of clinical database systems per Ozmosis Research standard operating procedures and guidelines, including:
• Development and design of electronic Case Report Forms (eCRFs)
• Development of database build specifications and edit checks
• Coordinating validation testing with database builders and study sponsors
• Conducting database amendments in collaboration with the database administrator and statisticians
-Liaising with the CTS/CTM to develop and conduct database and data collection training/user acceptance testing for sponsors and site staff.
-Communicating with the study team to ensure the database and data management timelines and scope of work are met.
-Maintenance and QC of the Medidata Lab Administration.
-Maintenance and tracking of database metrics in collaboration with Senior Management.
-Development and maintenance of the Ozmosis Global Library of eCRFs.
-Responsible for development of key data management documents including the Data Management Plan and eCRF Completion Guidelines, in collaboration with the CTS/CTM.

C. Leadership and Process Development

-Providing recommendations to develop and enhance Ozmosis data management SOPs and internal processes, templates, guidelines, and tools
-Organizing internal meetings with Senior Management and builders, including agendas and minutes

Prioritization is a key component and discussions with Ozmosis Senior Management should be undertaken whenever required. Other accountabilities and responsibilities may be required depending on business needs.