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Clinical Data Manager

Clinical Data Manager

Job Title: Clinical Data Manager
Contract Type: Permanent
Location: Los Angeles, California
Industry:
Salary: Negotiable
Reference: HQ000998_1491528797
Contact Name: Ben Richardson
Contact Email: b.richardson@sciproglobal.com
Job Published: April 07, 2017 02:33

Job Description

Clinical Data Manager

One of my key clients, based in Los Angeles is currently looking for a Clinical Data Manager to join their growing team.

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following:

  • Responsible for the clinical data management (CDM) activities for the entire life cycle of multiple clinical trials (Phase I - Phase III), from protocol concept review through completion of the clinical study report.

  • Define tools to collect, clean, monitor, and report data

  • Customize activities for each study based on the outsourcing model

  • Accountable and responsible for ensuring data quality and timeliness of study related CDM deliverables.

  • Coordinates study start-up activities; review and sign off of eCRF, eCRF completion guidelines, Data Validation (edit check) Specifications, data management plan (DMP), data review guidelines (DRG); coordinates database live activities; tests/accepts clinical database for EDC studies.

MINIMUM QUALIFICATIONS:

Experience: 10 to 12 years pharmaceutical experience, including data management and clinical trials. 8 or more years of progressively responsible experience in clinical data management, experience utilizing EDC and other data capture and management technology and experience in effectively collaborating with vendors to deliver quality work products.

Other:

  • Experience with clinical data management systems, proficiency in EDC/RDC (e.g. RAVE, Inform, Oracle Clinical), experience in basic SAS / SQL programming, and an understanding of CDISC, SDTM and other industry standards, experience with reporting tools like J-review is a plus.

  • Full Knowledge of the drug development, study conduct processes, regulations related to Data Management and clinical research such as CFR Title 21, ICH Guidelines, EU Directives, GCP and relevant regulatory compliance.

  • Extensive CRO management experience including day to day operations.

  • Full knowledge of clinical data flow in clinical trial conduct and submission.

If this is a role that you think could be of interest. Pelase get in touch with me or the team urgently.

Clinical Data Manager