Manager, Clinical Data Management - South San Francisco, CA | Biospace
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Manager, Clinical Data Management

CytomX Therapeutics, Inc.

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Location:
South San Francisco, CA
Posted Date:
7/17/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management, Manager,

Job Description


CytomX Therapeutics is unlocking the potential of antibody therapeutics in oncology by developing a novel therapeutic antibody class of highly targeted Probody™ therapeutics.  

CytomX is seeking a Clinical Data Manager to work collaboratively in a cross-functional team environment. We are seeking a highly-motivated individual to join the Clinical Data Management group within the Clinical Operations function. This individual will play a key role in ensuring accurate, high quality clinical trial data for outsourced trials in a fast-paced environment. Overall responsibilities will include oversight of clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals.  This position reports to the Associate Director of Clinical Data Management.

Responsibilities

•   Provides oversight of clinical data management activities across one or more early stage studies
•   Directs the development and maintenance of Case Report Form (CRF), CRF Completion guidelines, edit check specifications, data transfer specifications, and database audit plans  
•   Hands-on oversight of the build and development of the integration of IXRS (Medidata Balance) with EDC (Medidata Rave) and oversees change controls
•   Performs and organizes cross-functional User Acceptance Testing (UAT) of the integrated clinical databases
•   Works with clinical, biostatistics, and regulatory teams to design and develop study documents including Clinical Protocol, Case Report Forms (CRFs) and Statistical Analysis Plan (SAP)
•   Directs the interaction with contract data management groups to ensure that data management tasks remain on target per project timelines
•   Proactively organizes on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, and discrepancies by working with a contract data management group and internal stakeholders
•   Responsible for the correction of errors and 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
•   Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
•   Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
•   May lead new data management initiatives such as remote and central monitoring
•   Participates in the RFP process including the evaluation of potential vendors
•   May conduct CRO data management function inspections and audits
•   May contribute to the development and implementation of departmental policies, standards and process improvement initiatives
•   Demonstrates a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and Fun

Requirements


Requirements

•   Bachelor’s degree in clinical, biological, mathematical sciences or related field is required; an advanced degree is a plus; equivalent experience may be accepted in lieu of the degree requirement
•   Minimum 10 years of clinical data management experience in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience; previous oncology experience a plus
•   Minimum 5-years of Electronic Data Capture (EDC) experience; IXRS Balance development a plus    
•   Must have advanced knowledge of Data Management processes and systems
•   Solid understanding of clinical drug development processes is preferred
•   Must have demonstrated problem solving abilities in a team environment and strong organizational skills
•   Excellent written and verbal communication skills are required
•   Experience and understanding of ICH and GCP are required
•   Must be a demonstrated self-starter and team player with strong interpersonal skills
•   Experience with Medidata Rave and Balance and JReview preferred
•   Willing to travel on occasion