This is my direct-client opening for a *Sr. Data Management Consultant* for
a 4-6 month contract. The position is located in *San Francisco**, CA**.*
The Senior Data Manager Consultant (SDM) will be responsible for managing
the outsourcing of clinical studies to several contract research
organizations (CROs) and for the execution of the data management life cycle
process (e.g. CRF design through Database Lock). The SDM will coordinate
with the clinical operations team to ensure the accurate and complete data
collection for our global oncology and cardiovascular programs. The
consultant will be the key contact with the CRO for Data Management related
issues or problems and will liaise with internal customers to manage and
resolve Data Management issues. The SDM is responsible for ensuring that
Data Management deliverables are met.
*Responsibilities (included, but are not limited to)
Reviews, creates, and maintains the Data Management Plan throughout the
life-cycle of the study protocol, which includes: CRF annotation, database
specifications, edit checks, and other pertinent Data Management documents.
Provides leadership to and coordinates with the data management staff at the
CROs to ensure database lock and release of data for analyses. Spear heads
agenda and meeting minutes from CROs deliverables.
Monitors and tracks the quality of all data management deliverables ensuring
audit practices have been enacted to validate the quality and assurance of
database content from CROs as well as other external electronic data
Reviews and reconciles Serious Adverse Events and Adverse Event data.
Reviews coded adverse events and concomitant medication data.
Reviews and generates patient profile listings for internal or external
review, as well as laboratory data (e.g. Chemistry and Hematology) for
discrepancies and communicates any outstanding issues, for CRO action and
Coordinates and ensures smooth SAS datasets or electronic load data
transfers from CRO's.
Reviews and understands study protocols and other clinical related
Actively participates in clinical sub-teams presenting Data Management
concerns and issues.
Interacts with Director of Biometrics, Manager of Clinical Data Management,
Statisticians, Programmers, Clinical Trial Project Managers, Medical
Monitor, and other personnel to provide support in the areas of data
Provides input on existing or new SOPs and other procedural documents to
maximize productivity and efficiency with the Biometrics department.
Maintains an overall knowledge of regulatory guidelines, industry standards,
and new technologies.
Responsible for assigned studies or ongoing projects to ensure that work is
proceeding in an efficient manner and that project' timelines are met.
Communicates project status and key project issues to Manager of Clinical
Communicates back to clinical sub-team with post-mortem investigation of
previous studies (e.g. lessons learned) for study design and continuous
improvement of new studies.
Minimum of 5 to 7 years experience as a Senior Data Manager working within a
pharmaceutical or CRO environment, with overall exposure from inception to
conclusion in managing Phase I, II and III clinical studies.
Minimum of 2 to 3 years managing external vendors for Data Management in a
Minimum 2 to 3 years proficiency in the use of clinical database or systems
such as EDC, IVRS, Oracle Clinical(R), ClinTrial(R), and Integrated Review(R).
Understanding of Clinical Data Interchange Standards Consortium (CDISC) and
Therapeutic experience in oncology and cardiovascular is a must.
Bachelors Degree or equivalent in life science, computer science, business
or related discipline.
Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE.
Thorough knowledge of applicable regulatory rules and guidelines, including
Complex and/or international trials experience.
*Please complete the following skills-matrix and send back with your updated
Total Data Management Experience:
Total Pharmaceutical/CRO Experience:
Total Experience with clinical databases or systems such as EDC, IVRS,
Oracle Clinical(R), ClinTrial(R), and Integrated Review:
Total experience managing external vendors for Data Management:
Do you have understanding of the coding process and terms in MedDRA,
WHODRUG, and CTCAE?
Whether is it C2C/1099/W2?
Day Phone #:
Evening Phone #:
Cell Phone #:
*Thanks & Regards*………
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*BeyondTek IT - "Think Human. Think Technology. Think Beyond." *
*Phone (*:* *714-857-2010* Extn: *801
*Email ID ***:* [EMAIL PROTECTED] *
*Yahoo IM: Pramod_Beyondtekit*
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