Main Responsibilities and Required Skills for Clinical Data Manager
A Clinical Data Manager is a professional who is responsible for the collection, management, and analysis of data from clinical trials or other healthcare research studies. They lead Data Management activities and develop and maintain Data Management Plan and Data Management Report. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Clinical Data Managers.
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Main Responsibilities of Clinical Data Manager
The following list describes the typical responsibilities of a Clinical Data Manager:
Assess
Assess risks, setup and execute mitigation plans.
Assist in
Assist in basic database and edit check testing activities.
Assist in mentoring junior CDAs and / or contractors.
Assist in performing client relationship management activities.
Assist in programming eCRFs and database edit checks.
Assist in the creation and review of Data Management SOPs, WIs, and training materials.
Assist in the data management closeout and final data analysis for the final clinical study report.
Assist Investigative Site personnel with resolving queries.
Assist the CDM / SCDM / LCDM to prepare metrics at study level.
Assist the Manager, Data Management in the oversight and execution of Data Management operations.
Assist with designing CRFs, edit checks, and other system functions within EDC.
Assist with goal creation and performance.
Assist with implementation and testing of eCRF and reports.
Assist with mentoring and trains staff as appropriate in DM activities.
Assume
Assume full project management responsibility for all data management activities.
Build
Build and maintains a library of SAS programs and macros and develops surrounding processes.
Build effective relationships with CRO / vendor counterparts.
Carry out
Carry out all tasks related to database closure.
Code
Code medical terms in the clinical database, as required.
Collaborate
Collaborate with team members to draft and implement Change Controls for assigned projects.
Collect
Collect, analyze, and report on quality metrics to drive continuous improvement of our platform.
Communicate
Communicate with cross functional groups throughout the project lifecycle.
Conduct
Conduct training for site users / monitors on the clinical database.
Construct
Construct and own the library of integrated datasets and surrounding processes.
Contribute to
Contribute to data structure standards.
Contribute to projects and initiatives aimed at improving and optimizing the delivery of DMAR.
Contribute to regulatory documents and submissions.
Contribute to the implementation of standard operating documents to allow reusability of standards.
Cooperate
Cooperate and assist internal and external audits on assigned projects.
Coordinate
Coordinate and participate in the execution of user acceptance testing of data management tools.
Coordinate the archiving of study databases and related documents.
Coordinate the database lock preparation and monitoring of data integrity issues.
Coordinate the development and testing of data management systems edit.
Coordinate the development of SOP and Work Instructions for SAS programming activities.
Coordinate with hosting vender where need to setup CDM databases.
Create
Create and maintain clinical trial Data Management Study Binders.
Create and maintains data management documentation.
Create and provide training to the clinical team and sites.
Create and review electronic Case Report Form (eCRF) specifications.
Create data dictionary for data users.
Create Data Transfer Specifications and perform external vendor reconciliation.
Create, review, and process data queries and updates the databases.
Define
Define and program edit checks.
Design
Design and Maintain Clinical SharePoint Sites.
Design and maintain electronic clinical research management databases.
Design and review case report forms (CRFs / eCRFs).
Develop
Develop and maintain Data Management Project Plan (Plan).
Develop and maintain data validation specifications.
Develop and manages timelines and resources for SAS related activities.
Develop and / or review case report forms (CRFs) within =EDC system.
Develop and review Case Report Form Completion Instructions.
Develop CRF or review sponsor-generated CRFs.
Develop Database Define and program edit checks.
Develop Data Management Plan and Data Management Report.
Develop, document, and maintain automated testing systems and tools.
Develop Electronic Data Capture (EDC) clinical databases and user acceptance testing (UAT).
Develop key Data Management documents for presentation to and review by the sponsor.
Develop, review, and execute electronic data edit checks for web-based forms.
Develop study-specific eCRF Completion Guidelines.
Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
Direct
Direct communication with site personnel to assist in resolution of queries.
Document
Document deviations from the DMP.
Ensure
Ensure adequate application of Data Management Best Practice across studies within assigned projects.
Ensure approved study documentation is maintained and properly stored in the trial master files.
Ensure compliance to these SODs.
Ensure data management documentation is appropriated filed in the electronic trial master files.
Ensure resource availability and manages stakeholders.
Ensure stakeholders remain current on project requirements and manage sponsor expectations.
Ensure that quality of services meets internal and external customer requirements.
Ensure the quality of external data to meets standards for regulatory submissions.
Escalate
Escalate issues to Functional Manager and Project Manager as appropriate.
Escalate issues to LCDM as corresponds according to each process.
Escalate overdue items, including but not limited to outstanding questions and missing visits.
Establish
Establish data management best practices for data generated in relevant research activities.
Establish, monitor and maintain timeline for data management responsibilities.
Establish relationships with CROs for conduct of non-GLP as well as GLP studies.
Establish the data management strategy and plan for ongoing and planned clinical trials.
Evaluate
Evaluate and add queries to data where applicable based on edit check output.
Execute
Execute data validation activities in accordance with relevant Standard Operating Procedures.
Extract
Extract and monitor the trial data to identify issues.
Facilitate
Facilitate or participate in User Acceptance Testing (UAT) prior to study go-live.
File
File / archive essential documents.
Follow
Follow client software development methodologies.
Generate
Generate reports and data listings from EDC.
Identify
Identify and develop areas for improvement data management processes, standards and tools.
Identify, manage and communicate risk to timelines, quality and budget.
Input
Input into the data capture tools for a clinical study, including the eCRF and eCOA.
Interface with
Interface with clients to determines impacts of software changes.
Issue
Issue queries and follow them up until resolution.
Lead
Lead Data Management activities and ensure study deliverables meet timelines and quality standards.
Lead efforts to improve Data Management processes, as needed / assigned.
Lead initiatives to explore innovative study designs and statistical methods.
Lead studies as the Clinical Data Manager.
Lead the design of CRFs, CRF completion guidelines, and data handling conventions.
Lead the development of new concepts, technologies and products to meet emerging customer needs.
Lead the implementation of project documentation per 's procedures.
Liaise
Liaise with sponsors, sites, and project teams to address data issues and queries.
Maintain
Maintain internal data management study documentation to audit ready status.
Maintain Quality control of the clinical data, project deliverables and closeouts.
Maintain responsibility for analysis of Sybase and SQL code.
Manage
Manage and assist with data base audits as needed.
Manage CRF and queries and data reporting to ensure a clean database lock ready for analysis.
Manage external vendors who provide clinical databases development and data management functions.
Manage project resources per budget and within expected timeframes.
Manage the process of database modifications after go-live.
Manage vendor performance against study-specific Service Level Agreements.
Manage work performed by the vendor and CRO to ensure quality of product.
Mentor
Mentor all levels of Clinical Data Analysts in their job responsibilities.
Mentor and train Clinical Data Management staff.
Mentor junior level staff and peers on all associated tasks within a study.
Mentor junior staff on clinical data management activities and procedures.
Mentor / train Clinical Data Analysts.
Monitor
Monitor data for completeness and accuracy.
Monitor External Data Management processes, vendors, and CRO performance.
Monitor performance and reports status within area of responsibility.
Operate
Operate as a team and / or independently while demonstrating flexibility to changing requirements.
Oversee
Oversee discrepancy identification, query generation and management in EDC.
Oversee generation of Data Transfer Agreement(s) (DTAs) between external data vendors.
Oversee the build of statistical and data management file infrastucture.
Oversee the compilation of statistical analysis documentation for regulatory submissions.
Oversee the development of interim analysis reports for data monitoring committee.
Oversee the review of medical coding for validity and completeness.
Participate in
Participate in all validation testing for software and spreadsheets used within CDM team.
Participate in and / or contribute to Sponsor and / or Regulatory audits / inspections.
Participate in conference calls and / or vendor meetings.
Participate in EDC User Acceptance Testing (UAT).
Participate in Post Market Surveillance reporting as appropriate.
Participate in presentations to clients, sites, and cross functional groups.
Participate in programming edit checks and other system functions within EDC as needed.
Participate in project bid defense meeting when required.
Participate in the database design process.
Participate in working groups to develop and implement.
Perform
Perform as a Technical and Process Leader in Assigned Departmental or Corporate Level Projects.
Perform audits of biostatistical and data management documentation and file directory.
Perform basic medical coding activities and liaise with Medical Monitor for coding approval.
Perform database soft lock and hard lock activities.
Perform data review and query generation / resolution.
Perform Hands-on Data Management Activities.
Perform medical coding utilizing MedDRA and WHO-DRUG, as appropriate.
Perform or coordinate all data management activities for assigned studies, as appropriate.
Perform pre-, during, and post-data entry review of clinical data.
Perform quality control (QC) on study data and programs as needed.
Perform SAE reconciliation.
Perform Sponsor Data Entry as applicable per data management plans following entry guidelines.
Perform tasks which regularly require good correctable vision and hand / eye coordination.
Perform testing in accordance with SOPs and UAT plan.
Plan
Plan and implement data management timelines and deliverables.
Plan data refresh, migration, other initiatives related client Sybase applications.
Prepare
Prepare data tables for reports.
Prepare performance appraisals as part of the CDM performance management program for direct reports.
Provide
Provide general clinical operations management as requested.
Provide guidance to junior members of the Data Management group.
Provide mentoring and coaching to data management staff in daily operational activities.
Provide mentorship to new or inexperienced research staff.
Provide process and technical related recommendations and guidance to LCDMs.
Provide statistical support to areas outside of clinical development such as Translational Sciences.
Provide technical expertise in the SAS system as needed.
Provide updates directly to senior stakeholders as requested by management.
Raise
Raise questions to investigational site staff.
Release
Release engineering and management.
Report
Report DM metrics as appropriate to assigned study work.
Respond to
Respond to users requiring assistance with the EDC system.
Review
Review and author study protocols for in-vitro and in-vivo studies.
Review and enhance existing Sybase / SQL code to improve performance.
Review data, issue and resolve queries.
Review of Clinical research documents (e.g., Protocols, Case Report Forms).
Review result of applied Important Medical Event (IME) List, medical coding conventions.
Review study data for completeness and clinical sense.
Review Study Protocol Develop CRF or review of sponsor-generated CRFs.
Review work orders for database development and data management externalvendors.
Share
Share data arrival and cleanup status and metrics with the Study Team and Implementing Strategy.
Study
Study Database setup testing and Edit Check programming testing.
Supervise
Supervise and mentor Clinical Data Managers.
Support
Support achievement of project revenue and operating.
Support database validation activities as required.
Support LCDMs via consultancy and teaching by example and review as well as mentoring as needed.
Support pre-clinical testing and assist in developing pre-clinical research protocols and reports.
Support procedure room activities for data collection, monitoring and device accountability.
Support the department and company in achieving objectives and strategic goals.
Take
Take a leadership role in the development of assigned documents.
Track
Track study progress and issue periodic status reports.
Train
Train and mentor assigned employees on data management procedures and guidelines.
Train and support Clinical Data Associates and Clinical Data Managers.
Train other personnel on CRFs and EDC, as needed.
Tune
Tune queries, write Stored Procedures, perform indexing, and other database elements.
Understand
Understand critical tasks and milestones of the clinical project.
Understand the importance of quality clinical trial data leading to successful outcomes.
Update
Update the database to correct errors.
Use
Use and develop data views for optimal and efficient review of large quantities of data.
Utilize
Utilize experience and leadership skills to provide guidance to other team members.
Work with
Work with Biostatistician to program and verify statistical analysis programs.
Work with management to maintain the consistent execution of quality global procedures.
Most In-demand Hard Skills
The following list describes the most required technical skills of a Clinical Data Manager:
Clinical Trials
Life Science
GCP
CRO
CCDM
ICH Guidelines
Clinical Practice
Relational Databases
Business Ethics Requirements
SDC's Data Integrity
Microsoft Office Products
CDMS
EDC
Most In-demand Soft Skills
The following list describes the most required soft skills of a Clinical Data Manager:
Written and oral communication skills
Organizational capacity
Interpersonal skills
Leadership
Time-management
Attention to detail
Problem-solving attitude
Multi-task
Delegation abilities
Deal effectively with sponsors and internal customers
Presentation
Negotiating
Work independently and in teams
Analytical ability
Effectively collaborate across cross-functional teams
