Associate Clinical Data Manager
Location: San Francisco
Posted on: June 12, 2021
Associate Clinical Data Manager, FSP
Remote from anywhere in the U.S. or Canada
- Serve as a member of the project team with primary
responsibility for clinical data review, query generation /
resolution and reconciliation to support the delivery of clinical
data according to client quality and integrity specifications, and
project timelines and productivity targets.
- Potential to assist in the development of the project Data
Management Plan, including the creation of data acquisition
conventions and data review guidelines / diagnostics specification;
and set-up of the data management systems according to project
- Potential to serve as the technical data management leader on
small projects with technical oversight of data management
activities for the delivery of clinical data according to client
quality and integrity specifications, and project timelines and
- Review clinical trial data in accordance with [Global] Data
Management Plans and applicable standardized data management
processes (SOPs, Work Instructions, etc.) to identify erroneous,
missing, incomplete, or implausible data.
- Run ancillary programs (e.g., diagnostics, special listings,
reconciliation discrepancy listings) used to support the review of
clinical trial data.
- Generate, resolve and track queries to address problematic data
identified during data review activities and apply proper
modification / correction to the database.
- Interact with the dictionary coding and maintenance group to
ensure appropriate process set-up and application.
- Perform reconciliation of the clinical and safety
- Perform reconciliation of central laboratory and / or third
party vendor data (eCRF, edDiary, specialty laboratory, etc.).
- Perform aggregate review of clinical data by patient, site and
/ or project to identify data trends (patient safety, compliance,
etc.) and / or data inconsistencies that require further
- Apply quality control procedures and checks to ensure data
quality standards (client and Covance) are achieved.
- Potentially serve as a reviewer of project documents such as
protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF
(eCRF) completion guidelines, etc.
- Assist with the development of [Global] Data Management Plans
and Quality Management (QM) Plans that will deliver accurate,
timely, consistent, and quality clinical data.
- Assist in the development of the clinical data model and/or
database design and annotate the CRF (eCRF) according to these
- Assist in the creation of data acquisition conventions and data
review guidelines / diagnostic specifications consistent with the
clinical data model, [statistical] analysis plans, and CRF (eCFR)
completion / monitoring conventions.
- Assist in the development and testing of data management system
edit / data validation checks (diagnostics) and special listings /
procedures used as tools for the data review and discrepancy
- Potentially interact and collaborate with other project and
specialty team members (clinical, programming, statistics, CDM
technical support, drug safety, etc.) to support the set-up,
maintenance, and closure of the data management aspects of the
project to ensure consistent, cohesive data handling and
- Potentially serve as client contact for project meetings and
CDM status updates.
- Support the training of project staff on project-specific,
global, standardized data management processes.
- Perform other duties as assigned by management.
University/college degree (life science, pharmacy or related
subject preferred), or certification in a related allied health
profession from an appropriately accredited institution (e.g.,
nursing certification, medical or laboratory technology).
- In lieu of the above requirement, approximately 18 months
experience in related field (e.g. pharmaceutical, laboratory, data
analysis) incorporating approximately one year's clinical data
management experience in addition to the 4 years relevant work
experience in data management will be considered.
- Knowledge of drug development process.
- Knowledge of effective clinical data management practices.
- Knowledge of ICH Guidelines and GCP including international
regulatory requirements for the conduct of clinical development
- Fluent in English, both written and verbal.
Minimum 4 years relevant work experience with increasing
responsibility in data management with knowledge of 2 or more
- Demonstrated time management skill and ability to adhere to
project productivity metrics and timelines.
- Potential ability to lead by example data management
- Demonstrated ability to work in a team environment and
collaborate with peers.
- Demonstrated interpersonal skills.
- Excellent oral and written communication skills.
- Ability to demonstrate a constructive problem-solving attitude
while dealing with time demands, incomplete information or
Keywords: Covance, San Francisco , Associate Clinical Data Manager, Other , San Francisco, California
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