Manager-Data Management and Biostatistics, BD (Becton, Dickinson and Company), Durham, NC
Title: Manager, Data Management and Biostatistics – CLI10019
About us
BD, a leading global medical technology company that
makes and sells medical devices, instrumented systems and reagents, is
dedicated to improving people’s health throughout the world. BD
is focused on improving drug therapy, enhancing the quality and speed
of diagnosing infectious diseases, and advancing research and discovery
of new drugs and vaccines. The Company’s capabilities are
instrumental in combating many of the world’s most pressing
diseases. Founded in 1897 and headquartered in Franklin Lakes, New
Jersey, BD employs more than 25,000 people in approximately 50
countries throughout the world. The Company serves healthcare
institutions, life science researchers, clinical laboratories, industry
and the general public.
TriPath develops, manufactures, markets, and sells innovative solutions
to improve the clinical management of cancer, including detection,
diagnosis, staging, and treatment.
BD is an Equal Opportunity/Affirmative Action Employer
Description
Manages daily clinical trial data management and
biostatistics activities for assigned studies, under the guidance of
the Director of Clinical Operations. Provides oversight and
direction to internal and external data management team members
throughout the conduct of clinical trials. Designs databases,
oversees data integrity and accountability, and provides statistical
input and analysis for assigned clinical trials.
Principal Accountabilities:
1. Strategy and Planning:
Participates in clinical trial planning strategy sessions for assigned
projects, with focus on data management and biostatistics. In
collaboration with the Director of Clinical Operations and Clinical
Trial Managers, develops strategic and project-specific Data Management
Plans, including resources and timelines for assigned studies.
When necessary, helps identify, evaluate, and select data management
vendors for assigned projects.
2. Trial Execution:
Responsible for overseeing and maintaining all data management activities, including:
- Managing data management resources and timelines
associated with all study start-up, study conduct, and study closeout
activities for assigned studies, including CRF and eCRF development,
data tracking report development, electronic data capture (EDC) and
non-EDC database design and set-up, data entry/transfer, glossaries and
coding dictionaries development and maintenance, data import of
laboratory data, data validation, database management and maintenance,
interim database lock, final database lock, etc.
- May oversee data management activities provided by external vendors on assigned studies.
- Assumes primary accountability for ensuring that the
clinical data management team members are appropriately trained in data
activities, understand their own data responsibilities, and meet
project objectives within the established timelines and budgets.
- Interacts with data management staff, CRAs, and study
site contacts as needed to provide data tracking, resolve data queries
and lock clinical database(s) quickly and efficiently.
- Responsible for the final data accuracy, integrity, and completeness.
3. In conjunction with the project team, may provide strategic
biostatistical direction when planning assigned clinical trials.
May assist in interim analyses of the data during a trial.
4. Interacts with Biostatistics and Medical Writing personnel as
needed to ensure timely analysis and reporting of study results.
5. Has primary accountability for ensuring compliance with
applicable regulations, guidelines, and corporate policies for all
clinical data management activities on assigned studies.
6. Establishes and maintains performance metrics for data
management activities on assigned studies. Provides routine
status reports and updates to the Director of Clinical Operations and
Clinical Trial Manager(s) regarding the progress of assigned
studies.
7. Represents the data management function of the BD Diagnostics
-TriPath Clinical Operations Department to internal and external
customers. Serves as the liaison between Data Management
and other departments.
8. Writes and oversees the creation of internal and external
memos, reports, documents, and correspondence required to properly
manage and document data management activities on the studies.
Ensures maintenance of data management project files according to
applicable regulations, guidelines, and corporate policy.
9. In conjunction with the Director of Clinical Operations, plans,
implements, and documents auditing activities on assigned
projects. Participates in FDA inspections as required.
10. Serves as a resource/mentor for educating other members of the Clinical Team.
Qualifications
Job Dimensions:
- Ability to work on problems of moderate scope where
minimal direction is given for situational analysis is required, as is
the ability to exercise judgment within broadly defined practices and
policies to determine appropriate action.
- Normally receives minimal instructions on new assignments.
Education and Experience Required:
- Minimum of a High School diploma.
- 12 Years of data management and biostatistics experience.
- Minimum of two years’ experience managing a data management department or function.
- Previous experience working within an FDA-regulated industry.
- Experience leading data management teams through life cycles of clinical trials.
- Electronic data capture experience.
Education and Experience Preferred:
- Bachelor’s degree (B.A.) from a four-year
college or university with 8 or more years of data management and
biostatistics experience.
- Experience with data management for a Contract Research Organization (CRO), Medical Device, or Diagnostics company.
- Experience with SAS programming.
Supervisory Responsibility: The
Data Management Manager may have supervisory responsibility for 0-5
data management staff. Responsibilities include
interviewing, hiring, and training.
Profile
Job Category: Clinical Research & Trials
Location: United States-North Carolina-Durham
Shift: First Shift / Day Job
Relocation Available: No
To Apply:
http://www.bd.com/us/careers/
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