Clinical Data Manager de Mahwah, NJ em Stryker Corporation

Data de Postagem: 9/14/2019

Resumo do Emprego

Descrição do Emprego

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
  • Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As a Clinical Data Manager, you will perform data management activities for clinical studies from preparation to close out. You’ll manage clinical database systems and provide support to clinical studies through detailed data review, ensure compliance with federal regulations, Good Clinical Practices and department SOPs. Additional responsibilities include:

  • Perform data management activities for Stryker sponsored studies, including protocol review, eCRFs/CRF specifications/edits specification development, database set-up activities, Data Management Plan creation and management, imaging data process, data review and reconciliation, database lock, etc.
  • Build clinical study database in Medidata systems which includes EDC and Imaging setup, edits and custom functions creation, user acceptance testing (UAT), and production go-live.
  • Perform comprehensive hands-on data review of all CRF data through data review, query management and manual review
  • Oversee data entry quality control, create worksheets, review findings, calculate error rates and approve quality control report
  • Coordinate all cycles of data management during data review and generate data discrepancy criteria
  • Review listings for quality, content, format and output
  • Participate in x-ray review and ensure quality of process
  • Oversee and conduct x-ray quality control on a quarterly basis
  • Work in collaboration with Sr. Data Manager and Clinical Study team to assure timely study development and clinical data reports
  • Supervise the locking process of study database and sign off approval
  • Design and/or participate in design of data management documentation and SOPs
  • Participate in preparation and presentation of data management activities and new initiatives
  • Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics Business Process Excellence initiatives

What you need

  • Bachelor’s degree required
  • 5+ years of experience in clinical data management within the drug or medical device industry
  • Experience with EDC (Rave preferred but open to other EDC such as Inform)
  • Knowledge of eCRF design
  • Hands-on experience conducting all data management activities
  • Strong project management skills to effectively and independently manage a project
  • Knowledge of drug or medical device study development
  • Knowledge of The Good Clinical Data Management Practices (GCDMP) and Food and Drug Administration (FDA) medical device regulations and guidelines
  • Experience developing and maintaining Standard Operational Procedures (SOPs)

You might also have

  • Rave study build certification
  • Team-based work experience
  • Strong written, verbal, analytical and time management skills
  • Good knowledge with SAS dataset structure and SAS reporting function

Work From Home: No

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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