Associate Director, Clinical Data Management - San Carlos, CA | Biospace
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Associate Director, Clinical Data Management

Iovance Biotherapeutics, Inc.

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Location:
San Carlos, CA
Posted Date:
9/14/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management, Director,

Job Description


Overview

The Associate Director, Clinical Data Management, provides technical and operational expertise to the project teams and is responsible for ensuring the data collected meets the requirements of the study objectives for the purpose of clinical study reports, publications, and regulatory submissions. This position will lead and coordinate functions for multiple assigned projects related to the planning, execution, collection, and cleaning of clinical data.  The Associate Director, Clinical Data Management will work within the company’s SOPs, guidelines and standards to ensure data integrity at all times.

Specific Responsibilities

•   Works to improve clinical data management processes to ensure optimal procedures.
•   Helps apply metrics and data analysis to identify and implement process, quality, and system improvements.
•   Represents the department on company, division, or department-level process improvement initiatives.
•   Lead database design and implementation for new or ongoing studies.
•   Oversight of all clinical data management activities, database cleaning and lock activities including developing data management plans, supervising database development and reviewing and processing clinical trial data to ensure completeness, accuracy and consistency of clinical trials databases.
•   Work with the CRO and other vendors to coordinate activities for the medical review of coding data and approval of adverse events, medical history, concomitant and protocol-related medications.
•   Establish and promote use of standards.
•   Lead initiatives to gather, organize, and analyze interim clinical data from various data sources, and examines issues from various perspectives.
•   Audit potential data management vendors, as appropriate.
•   Serve as a technical resource to colleagues; troubleshoot technical problems.
•   Coordinate the transfer of clinical data between all vendors participating in a clinical study.
•   Assist in the compilation of clinical data for regulatory submissions

Requirements


Education and Qualifications

•   7 years of experience and a BS degree. 5 years of experience and a MS degree. 3 years of experience and a PhD
•   9 - 10 years of CDM experience
•   Excellent verbal and written communication skills and strong interpersonal skills are required.
•   Experience with Electronic Data Capture (EDC)
•   Familiarity with clinical data management systems and industry wide thesauri
•   Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner