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BD (Becton, Dickinson and Company) Clinical Data Manager in Franklin Lakes, New Jersey

Job Description SummaryThe Clinical Data Manager is responsible for supporting all data management aspects 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 the agreed upon project timelines. 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, electronic data reconciliation and identification of protocol deviations.

Job Description

Essential Job Functions:

  • Provide input into study protocols to ensure the data collection requirements are clear and supportive of the study endpoints.

  • Establishes and maintains productive working relationships with all other functional areas that contribute to the execution of clinical studies.

  • Work with business unit personnel to ensure GCD is delivering high quality and timely data management services necessary to achieve their business goals.

  • Accountable for the quality and timeliness of all Data Management activities from CRF design through database finalization and document archiving.

  • 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 Guidelines to serve as an aid for site personnel to complete CRFs.

  • Define Edit Check specifications and work with Database Programmers to ensure accurate and timely programming.

  • Develop and maintain a Data Management Plan.

  • Perform user acceptance/database 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 as needed.

  • Contributes to the development of DM SOPs, Business Guidance and/or Departmental Standards.

  • 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 as needed.

  • Train GCD and/or external personnel in CDMS technology or data management process.

  • 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 an understanding of data structures, database design constraints and needs of SAS and Clinical Database Programmers.

  • Provides mentoring/coaching of new hires and/or junior associates.

  • Maintains accurate and complete study records.

Required Qualifications:

  • Knowledge of database application concepts.

  • Knowledge of data management processes and industry standards.

  • Knowledge of EDC/RDC technology experience required.

  • Fundamental project management skills

  • Effective communication skills both verbal and written.

  • Ability to work independently with minimal supervision and accountable for managing multiple assignments concurrently.

  • 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.

  • Experience with MS Word, Excel and PowerPoint.

  • Ability to travel up to 10% of the time.

Additional Desirable Qualifications Skills and Knowledge:

  • Anticipates problems, issues, and delays; proactively looks to minimize the impact to the project.

  • Basic knowledge of SQL preferred to troubleshoot edit check programming and/or reports.

  • Basic understanding of SAS concepts preferred.

  • Knowledge of JReview preferred.

  • Fundamental knowledge of adverse event and medication coding dictionaries preferred.

Education and/or Experience1:

  • Undergraduate degree required (life sciences preferred) from an accredited program or an equivalent combination of education, industry related experience, and performance may be considered.

  • Minimum 3 years Clinical Data Management experience.

Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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Primary Work LocationUSA NJ - Franklin Lakes

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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