Lead Clinical Data Manager

Essential Duties and Responsibilities:

• Coordinate deliverables on assigned projects depending on the relevant model and Data Management (DM) Vendor. Serves as the first line of contact at the project level.
• Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop Data Management Plans that will deliver accurate, timely, consistent, and quality clinical trial data.
• Independently perform all activities related to data management per regulations and applicable standard operating procedures (SOPs).
• Primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.
• Primary contact person for communication and discussion of topics related to data management timelines and deliverables, request for out of scope tasks, and first line contact for technical or procedural issues.
• Responsible for planning and implementing data management timelines and deliverables, for providing database and data management activities status reports, and contributes to the overall project planning, progress tracking and reporting.
• Design and review electronic Case Report Forms (eCRFs). Develop and review eCRF Completion Instructions. Generate and review annotated eCRFs.
• Develop and maintain data validation specifications.
• Fully involved in the clinical study database User Acceptance Testing (UAT), and ensure proper documentation thereof.
• Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
• Regularly communicate and/or respond to data collection sites, third party service providers, and when appropriate sponsors; responding to queries in a timely manner, addressing data collection and/or quality issues effectively ensuring customer expectations are managed appropriately and data-related communications/updates remain current and relevant.
• Perform third party non-eCRF data management activities, including data transfers and Serious Adverse Event (SAE) reconciliation.
• Work collaboratively with the other departments within Medrio to meet project deliverables and timelines for clinical data management.
• Cooperate and assist the Quality Systems department with quality control audits on assigned databases.
• Perform database soft-lock and hard-lock activities.
• Other duties & responsibilities as required.

Customers or Clients:

• Internal, external

Education and Years of Experience:

• A minimum of 5 years of clinical data management related experience in either a CRO, pharmaceutical, biotech, or device company.

Working Conditions (include any required travel): 

• Remote

Other Skills and Abilities:

• In-depth understanding of database structures and database programming.
• In depth knowledge of CDISC SDTM/CDASH standards. 
• In-depth knowledge of clinical trial processes and experience in ICH, GCP, and GCDMP (SCDM).
• Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A. 
• The proven ability to provide leadership and think strategically to achieve business goals.
• Strong analytical, problem solving, and technical skills in database programming. 
• Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
• Knowledge of at least one computer programming language is an asset.  
• Must have strong communication (both verbal and written), interpersonal, and client services skills.
• Must be highly organized and self-motivated.

About Medrio:

At Medrio, we look for smart, capable, and conscientious people to help us expand our product capabilities, grow our business, and better serve our customers. Our employees love working for us because they get to develop, market, and sell a product that advances human health, and they enjoy many perks, including:

• 25 Days Holiday + Bank Holidays
• Pension 
• Gym Membership contribution
• Private medical cover
• Remote working  

The Medrio team is made up of individuals with a wide array of skills and interests, but all have a passion for providing the best possible user experience for our customers. We value collaboration, ingenuity and creating a culture of excellence!

Salary Range: $90,000 - 105,000 CAD

To see detailed information on the data we collect during the application process, and how Medrio complies with data privacy laws, visit our Careers page.

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