Job Description SummaryThe Associate Clinical Data Manager will support all data management aspects including start-up, maintenance, and completion activities. The primary objective of this position is to ensure clinical study data are 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, database testing, electronic data reconciliation and identification of protocol deviations. # Job Description Essential Job Functions: + Review study protocols to ensure the data collection requirements are clear and supportive of the study endpoints. + Contributes to the development of DM SOPs, Business Guidance and/or Departmental Standards. + Establishes and maintains productive working relationships with all other functional areas that contribute to the execution of clinical studies. + 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 Data Manager and 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 Clinical 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. + 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. + Generate status reports and distribute to the study team and clinical study sites as appropriate. + Follow-up with study team members and study sites as appropriate on outstanding items. + Assist with the CRAs preparation for on-site monitoring activities. + Maintains knowledge of current regulations and technologies related to the data management function. + Develops an understanding of the concepts 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 data management processes and industry standards. + Knowledge of EDC/RDC technology experience required. + Experience with MS Word, Excel and PowerPoint. + Effective communication skills both verbal and written. + Ability to work independently with minimal supervision. + 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. + Ability to travel up to 10% of the time. Additional Desirable Qualifications Skills and Knowledge: + Knowledge of JReview preferred. Education and/or Experience1: + Undergraduate degree preferred (life sciences preferred) from an accredited program. + Minimum 2 years Clinical Data Management experience. 1 An equivalent combination of education, industry related experience, and performance may be considered. 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. #LI-PRO # Primary Work LocationUSA NJ - Franklin Lakes # Additional Locations # Work Shift 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.