Global Specimen Solutions (GSS) is wholly owned company of Covance Inc., providing specialty services in the holistic specimen tracking space. GSS improves translational science through industry best practices and a uniquely powerful pipeline data management analytics solution. GSS reduces the time, cost and risk of specimen based research, while building robust, healthy data pipelines that optimize research opportunities.
Assistant Data Manager for Global Specimen Solutions is responsible and accountable to deliver tasks according to procedural requirements and agreed upon service levels of Global Specimen Solutions for Covance Central Laboratory Services.
- Work with the internal DM leads to coordinate and fulfill requests related to protocol-specific data management requirements.
- Lead and support Data Manager Lead during startup and working with the client’s vendors to obtain data required to meet the key objectives.
- Interacts with the internal Project Managers to coordinate and fulfill requests related to protocol-specific data management needs.
- Assigns Data Management staff to client studies per team and mentors DM associate and specialist as needed.
- Create the data transfer agreements for vendors
- Works with internal staff to maintain data and resolve any data issues.
- Adhere to all Data Standard guidelines applicable to data management
- Work with Data Management leads to understand and assist resolve the issues.
- Track progress of assigned tasks in management operating system
- Assist Quality Assurance in SOP writing and review
- Any corporate activities assigned
- Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards in relation to the System Development Life Cycle.
- University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology).
- In addition to above, Candidates without life sciences background but with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities.
- Minimum 6-8 years of data management experience or equivalent work experience in a regulated (FDA, EPA, etc.) environments.
- Good knowledge in Database Management concepts with SQL knowledge and, writing SQL queries to pull data for analysis/resolution purpose
- Conversant with databases and database terminology.
- Prior knowledge on understanding the protocols and study start-up
- Prior experience working with clinical trial data and reporting issues.
- Ability to work in a rapidly changing environment.
- Independently analyze, solve, and correct issues in real time, providing problem resolution end-to-end.
- Self-motivated, able to work with minimal oversight
- Detail oriented, ability to work independently and ability to work/communicate effectively with teams.
- Can work in compliance with departmental and business-related procedures
- Strong communication and interpersonal skills.
- Strong MS/Office skills in particular with Excel and Word.
- Has knowledge of GlobalCode (able to navigate and understand reports)
- Is able use GSS Ops (for tickets, tasks, cronjobs, mapping, and loader creation)
- Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
- Understanding of database query tools, such as DB Forge or Navicat, is an advantage.
- In addition to above, candidates with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities
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