Clinical Data Manager

San Diego - CA

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Job Description

Clinical trials/research, including associated equipment and computer systems:

·       Lead the process of Case Report Forms (CRF)/Electronic Case Report Forms (eCRF) development for a study.

·       Lead the development and maintenance of the CDM plan.

·       Design and test studies in the data management system for use on paper-based CRF and eCRF studies.

·       Create study-specific data entry instructions and conventions.

·       May participate in data entry from paper CRFs as needed.

·       Create and maintain the data validation specifications.

·       Design edit checks within the data management system that conform to the data validation specifications.

·       Perform discrepancy management within the data management system.

·       Routinely review data issues with internal site staff to minimize discrepancies.

·       Update study database (paper CRFs) and assist Clinical Project Management Data Entry Associates with updates (eCRFs) according to discrepancy responses.

·       Develop data listings from the data management system to perform data review that may result in discrepancies.

·       Create and maintain study status reports for tracking CRF/eCRF completion, discrepancy management, and other study metrics as needed.

·       Perform medical coding of adverse events and concomitant medications.

·       Manage and QC data received from external vendors.

·       Prepare and QC internally-generated data for review by CRAs and for transfer to sponsors or CROs.

·       Support the Associate Director, Clinical Data Management, in the oversight of CROs for any outsourced studies.

·       Attend team meetings as needed to represent CDM interests.

·       Assist in the development, maintenance, and monitoring of CDM policies, standards, and practices.

·       Review protocols and provide input relevant to data management issues.

·       Provide input for the development of project specific timelines and budgets.

·       Train on department specific Standard Operating Procedures (SOPs) and Work Instructions (WIs).                    

Skills & Requirements

·       Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgement; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.

·       Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.

·       Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.

·       Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.

·       Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn’t stop at the first answers.



To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Bachelor’s degree in Life Sciences or Mathematics and/or formal or on-the-job training in clinical trial methodology and Good Clinical Practice (GCP) plus five or more years of experience in direct data management experience at a CRO, pharmaceutical, or biotechnology company and/or an equivalent combination of education and experience. Experience writing SOPs and training documentation.

Skills, Knowledge, and Abilities:

Technical competency using data management systems, especially EDC systems. Understanding of US and International Regulatory mandates and guidance for clinical research including FDA/ICH-GCP. Demonstrated ability to manage a complex workload and prioritize tasks based on program goals. Ability to work quickly and independently and as a strong team player.

Language Ability:

Ability to read and interpret documents such as safety rules, SOP’s, WI’s, procedural manuals, governmental and clinical regulations, and similar documents. Excellent oral, written and interpersonal communication skills with the ability to communicate effectively to employees and Management groups and in group meeting settings.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

To perform this job successfully, an individual should have intermediate knowledge of the current MS Office Suite.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to outdoor weather conditions. The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch, or crawl.