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C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.
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| Summary of Position with General Responsibilities: |
This data coordinator will serve as the technical leader on all data management aspects for Bard clinical studies, including start-up, maintenance, and completion activities. The primary purpose and objective of this position is to standardize process and implement best practices in an effort to improve quality, streamline data cleaning efforts and deliver analyzable databases within agreed upon project timelines. He / she will perform and / or coordinate the following activities: development of data specifications and the data management plan, participate in the validation of the clinical database, conduct data review, query generation, data coding, electronic data reconciliation, and identify protocol deviations. The data coordinator will manage workflow and oversee data management activities performed by in-house data entry / review project staff and or selected CROs.
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| Essential Job Functions: |
- Contribute to the design of protocol, design and approve high quality CRFs on which data are collected and development of CRF completion guidelines;
- Work with statistician and the clinical team to develop and implement a library of standard case report modules, pages and books;
- Work with the statistician and data management group to develop and implement a library of system edit / data validation checks and special listing / procedures used as tools for the data review and discrepancy management activities,
- Contribute to development of data management SOPs, guidelines and productivity metrics;
- Assist with database design to ensure it meets requirements for the entry and reporting of clinical data;
- Develop data management plans that will deliver accurate, timeline consistent and quality clinical data;
- Identify and implement solutions to data management issues and concerns that arise during the conduct of the study;
- Manage tasks related to quality control review of clinical data, critical variables and laboratory reference ranges;
- Serve as project liaison, resolving and or escalating issues as needed;
- Continually evaluate data management processes and applications for improvement,
- Train CRAs to help improve the quality of the data being collected;
- Maintains knowledge of current regulations and technologies related to the data management function.
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| Basic Qualifications: |
• Undergraduate degree, appropriate certification or equivalent clinical data management experience (Pharmaceutical, CRO or device) required.
• Fundamental knowledge of adverse event and medication coding dictionaries preferred
• Expert in the use of data management applications
• Experience with Excel
• Understands clinical research process and regulatory requirements
• Able to acquire and apply new technical skills
• Establishes rapport and collaborates with others (internal and external) team members; builds constructive and effective relationships
• Anticipates problems, issues, and delays; proactively looks to minimize the impact to the project
• Follows through on all tasks and ensures quality results
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| Additional Desirable Qualifications Skills and Knowledge: |
• 2 years Clinical Data management system experience (Oracle Clinical, ClinTrial, eData Management etc) preferred
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| Education and/or Experience: |
- Undergraduate degree, appropriate certification or equivalent clinical data management experience (Pharmaceutical, CRO or device) required.
- Fundamental knowledge of adverse event and medication coding dictionaries preferred
- Expert in the use of data management applications
- Experience with Excel
- Understands clinical research process and regulatory requirements
- Able to acquire and apply new technical skills
- Establishes rapport and collaborates with others (internal and external) team members; builds constructive and effective relationships
- Anticipates problems, issues, and delays; proactively looks to minimize the impact to the project
- Follows through on all tasks and ensures quality results
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| Work Environment: |
- Travel may be required up to 10% of the time
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