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Senior Data Manager

Responsibilities:

The Senior Data Manager will lead all data management aspects for assigned Bard clinical studies, including start-up, maintenance, and completion activities. The primary objective of this position is to ensure clinical study data is collected, handled and validated in an appropriate and consistent manner to ensure a high quality database is delivered for statistical analysis within agreed upon project timelines. In addition, the Senior Data Manager will be looked upon to standardize process and implement best practices in an effort to improve quality and streamline data cleaning efforts. He / she will perform and / or coordinate the following activities: development of Case Report Forms (CRFs), development of database specifications, development of edit check specifications and the Data Management Plan, conduct data review, query generation/resolution, data coding, electronic data reconciliation and identification of protocol deviations.

Essential Job Functions

  • Provide input into study protocols to ensure the data collection requirements are clear and supportive of the study endpoints.
  • Design high quality CRFs in consultation with a cross functional team that accurately reflect the data collection requirements identified in the study protocol and that are consistent with internal standards.
  • Assist with database design to ensure it meets requirements for the entry and reporting of clinical data.
  • Develop CRF Completion Instructions to serve as an aid for site personnel to complete the CRFs.
  • Define Edit Check specifications and work with Database Programmers to ensure accurate and timely programming.
  • Develop Data Management Plan.
  • Perform User Acceptance Testing to ensure the quality and integrity of the clinical study database design and associated edit check programming prior to the study database being released to collect data.
  • Conduct data review and associated query generation/resolution.
  • Perform Database Finalization activities and deliver quality results within agreed upon project timelines.
  • Perform data reconciliation activities by comparing CRF data to Non-CRF data from external vendors.
  • Lead/Author SOPs, Business Guidance and/or Departmental Standards.
  • Identify and understands the need for standardization and takes initiative to help improve departmental efficiency.
  • Identify and implement solutions to data management issues and concerns that arise during the conduct of the study.
  • Serve as project liaison, resolving and or escalating issues as needed.
  • Train CRAs and/or site personnel in Remote Data Capture technology.
  • Identify trends in data completion and work with CRAs and/or site personnel to help improve the quality of the data being collected.
  • Maintains knowledge of current regulations and technologies related to the data management function.
  • Demonstrates project management skills including the ability to manage Data Management aspects for outsourced studies.
  • Demonstrates an understanding of data structures, database design constraints and needs of SAS Programmers.
  • Provides mentoring/coaching of new hires and/or junior associates.
  • Maintains accurate and complete study records.

Basic Qualifications

  • Minimum 5 years Clinical Data management experience.
  • Knowledge of Oracle Clinical.
  • Knowledge of database application concepts.
  • Knowledge of data management processes and industry standards.
  • Knowledge of EDC/RDC technology experience required.
  • Fundamental knowledge of adverse event and medication coding dictionaries preferred
  • Experience with MS Word, Excel and Powerpoint

Additional Desirable Qualifications Skills and Knowledge

  • Effective communication skills both verbal and written.
  • Ability to work independently with minimal supervision and accountable for managing multiple studies concurrently.
  • Demonstrates leadership qualities.
  • Understands clinical research process and regulatory requirements.
  • Able to acquire and apply new technical skills.
  • Establishes rapport and collaborates with other (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.
  • Knowledge of JReview preferred.
  • Basic knowledge of SQL preferred to troubleshoot edit check programming and/or reports.

Education and/or Experience

  • Undergraduate degree required (life sciences preferred) from an accredited program.
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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 13,000 people around the world. Founded in 1907, 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. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard and ultimately, you can have an impact on the lives of people around the world.

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