Sr. Clinical Data Management Specialist

San Francisco, CA, United States
Sep 04, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Assists in planning, implementation and overall direction of executing/achieving clinical trial data management activities.

Manage Contract Research Organizations (CROs) and service providers' activities in overseeing the data management process life cycle. Collaborates with various departments on the design, documentation, testing and implementation of clinical databases. Develops systems for organizing data to analyze, identify and report trends. Analyzes the interrelationships of data and defines logical aspects of datasets. Prepares reports of clinical trial data for internal validation and cross study validation. May evaluate and resolve issues regarding contents of reports. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Determines methods and procedures on new assignments. Works with cross-functional teams including clinical, biostatistics, drug safety, medical, and regulatory teams to design, document, test and implement data collection instruments and Data Management study documents.vAssists with the interaction between contract data management groups and 3rd party vendors to ensure that data management tasks remain on target according to project timelines. Proactively organizes on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies by working in conjunction with the internal team as well as external vendors. Responsible for the correction of discrepancies through the site query process, for documenting permanent data issues, routinely communicating issues with team members and the delivery of a quality locked database for analysis. Contribute to the development and implementation of departmental policies, standards and process improvement initiatives.

A bachelor's degree in clinical, biological or mathematical sciences or related field, or nursing qualification. A master's degree is preferred. Equivalent experience may be accepted. Typically requires a minimum of 5 years of experience in Clinical Data Management. Advanced knowledge of EDC systems and Data Management processes. Outstanding written and oral communication skills. Solid understanding of clinical drug development process is preferred. Excellent organizational skills and demonstrated ability to manage projects. Effective problem solving skills

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.