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BD (Becton, Dickinson and Company) Sr. Scientist, Clinical Trial in Baltimore, Maryland

Job Description Summary

The Sr. Scientist is responsible for clinical trial management of multiple studies including the planning, execution, and completion of clinical trials conducted for molecular assays for human in vitro diagnostic devices. The Sr. Scientist will ensure that the Investigator Site File (ISF) and Data Binders for each clinical trial are maintained according to Good Clinical Practices (GCP). In addition, the Sr. Scientist is responsible for specimen management including inventorying, maintaining records, and shipping of specimens. Assists in collecting specimens during internal collections. Collaborates with Clinical Study Manager, Clinical Research Associate, Medical Affairs, and R&D during each clinical trial. Works with minimal supervision under the general guidance of Manager.

Job Description

Duties and Responsibilities:

  • Manages the schedule and execution of multiple clinical trials.

  • Enters clinical data into Clindex and/or uploads data to sFTP sites.

  • Maintains Investigator Site File (ISF) and Data binders according to Good Clinical Practices (GCP).

  • Supervises the work of Scientist I and Scientist II clinical associates in the lab.

  • Reviews and edits as needed clinical trial protocols and any subsequent publications.

  • Addresses issues that may arise during execution of clinical studies.

  • Responds and approves data clarification forms (DCFs) and Case Report Forms (CRFs) that arise during clinical studies.

  • Is responsible for the maintenance of complex laboratory equipment within the clinical lab.

  • Inventories specimens and supplies for clinical trial and internal collections.

  • Ships and receives clinical specimens according to Category B shipping requirements.

  • May write and execute specimen stability protocols to support usage of panels or retrospective samples during clinical studies.

  • May assist R&D with experiments during development or qualification.

Knowledge and Skills:

  • Knowledge of clinical trial concepts and Good Clinical Practices (GCP).

  • Demonstrated ability to plan and execute clinical trials.

  • Meticulous technique in handling of clinical specimens is required.

  • Excellent organizational and communication skills.

  • Demonstrated ability to supervise 1-3 associates.

  • Ability to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment.

Education and Experience:

  • Minimum of Bachelor’s degree in Medical Technology, Clinical Laboratory Science, Molecular Biology, Microbiology, Biochemistry, or related discipline with a minimum of 4 years of directly relevant experience in clinical trials or related field. Or Master’s degree with a minimum of 2 years of directly relevant experience in clinical trials or related field.

  • Minimum of 1 year of staff management and development skills.

  • Experience handling infectious biological samples and working in a GCP environment are required.

  • Work experience in specimen management and shipping Category B substances is preferred.

  • Project management experience is desirable using MS Project.

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.

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Primary Work Location

USA MD - Sparks - 52/54 Loveton Circle

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.

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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