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Sr. Clinical Data Manager

Company:
Artech Information Systems
Location:
South San Francisco, California, United States
Posted:
December 18, 2018

Description:

Job Description:

Job Title: Sr. Clinical Data Manager

Job ID: AZNJP00008511

Location: South San Francisco, CA

Duration: 12 Months

Job Summary

The Clinical Data Manager (CDM) is responsible for all aspects of the data management process from the development of project documentation, system set-up, UAT through database lock for assigned studies.

Essential Duties/ Responsibilities

Department Level:

• Participates in the development, review and implementation of departmental SOPs, templates and processes

• Supports budget and resource planning across assigned projects

• Contributes to technical infrastructure of data management

• Participates in CRO/vendor selection process for outsourced activities

• May participate in department or cross-functional initiatives

DM/Study Tasks:

• Represents data management in study team meetings

• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines

• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)

• Executes and/or distributes data management metrics, listings, and reports, as required

• Oversight of data management CRO/service providers on assigned studies

• Monitors the progress of all data management activities on assigned studies to ensure project timelines are met

• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed

• Proactively identifies potential study issues/risks and recommends/implements solutions

• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal

• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables

Requirements

• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements

• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email

Required Skills:

• Good working knowledge of ICH, FDA, and GCP regulations and guidelines

• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)

• Knowledge of industry standards (CDISC, SDTM, CDASH)

• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.

Education/ Training

• Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field

• Minimum of 5 years of SENIOR-LEVEL DM (i.e., Sr. CDA) experience in the pharmaceutical or biotechnology industry or equivalent; depth and exposure to DM related tasks considered in lieu of minimum requirement

• CRO management experience desired

• Competence in SAS programming a plus

• Prior oncology/hematology experience highly desirable