Clinical Data Manager Job Description

Clinical Data Manager Job Description

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Clinical data manager provides leadership and training for Data Management staff assigned including Clinical Data Managers, Clinical Data Coordinators, clinical operations and additional ancillary personnel.

Clinical Data Manager Duties & Responsibilities

To write an effective clinical data manager job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical data manager job description templates that you can modify and use.

Sample responsibilities for this position include:

Serves as a contact representing DM within Biometrics and clinical study management teams (SMT and/or Clinical Development Team representatives)
Direct management of the coding function, CDMP coordinator and coordination of communication between physicians, coding team and CDI specialists
Regular review of 3rd party edits, and preparing and delivering corrective action
Assisting with development, of and maintains and monitors implementation of JATA clinical documentation improvement program
Developing and coordinating educational and training programs regarding elements of HIM compliance program relative to the revenue cycle
Coordinating ICD 10 training throughout the organization through the ICD 10 Task Force team
Developing, implementing, and monitoring query process adjusting to changes in regulatory requirements as they come into effect
Monitoring unbilled reports daily for outstanding and /or uncoded outpatient and inpatient encounters
Monitoring productivity of the coding team, communicates to outsource manager any discrepancies, backlogs and issues
Monitoring inpatient case mix reports and top 25 assigned DRG’s in the facility to identify patterns, trends, and variations evaluating potential causes of issues and suggesting corrective action

Clinical Data Manager Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Data Manager

List any licenses or certifications required by the position: CCDM, CPC, PMP, SAFE, SAS, BLS, SCDM, ACRP, SOCRA, RHIA

Education for Clinical Data Manager

Typically a job would require a certain level of education.

Employers hiring for the clinical data manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Nursing, Pharmacy, Health Care, Biological Sciences, Medicine, Management, Computer Science, Life Science, Science, Life Sciences

Skills for Clinical Data Manager

Desired skills for clinical data manager include:

Clinical operations
Biometrics
Effective clinical data management practices
Good Clinical Practices and applicable Standard Operating Procedures
Medical terminology
Clinical trial process and data management
Quality management
Systems applications to support operations
GCP
Especially as related to data handling and processing

Desired experience for clinical data manager includes:

Continuously evaluating the quality of clinical documentation to spot incomplete or inconsistent documentation
Providing accurate statistics and reports as requested and for reporting outcomes
Serving as the facility representative for coding/clinical data management by attending coding and reimbursement workshops and brings back information to the appropriate departments
Performing periodic claim form reviews to check code transfer accuracy from the abstracting system to the billing files
Evaluating and responding to 3rd Party notices, including Recovery Audit program memos for DRG change, coding change or denial notices
Interviewing, training, monitoring, counseling, and disciplining as necessary adhering to department and hospital policy

Clinical Data Manager Examples

1

Clinical Data Manager Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical data manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical data manager
  • Direct activities of contract Data Manager staff
  • Ensure oversight of the Data Management CRO
  • Provide status reports/updates, resolve disputes, and ensure timely acquisition of high quality deliverables from the CRO
  • Provide Data Management expertise to the team in identifying opportunities for process and budgetary optimization
  • Ensure Data Management CROs are delivering quality data and documentation on time, on budget and to quality standards and SOPs
  • Participate in decision making processes to ensure maximum performance of the team
  • Provide Data Management expertise to teams
  • Lead development of Data Review Plans
  • Review and contribute to the development of trial validation plan related documents
  • Create/approve final design drafts
Qualifications for clinical data manager
  • Validate checks and reports necessary to assure high quality and consistent data
  • Review and contribute to the preparation of protocols, CRFs and prepare or review/contribute to operations manuals
  • Organize / chair data management meetings
  • Support and assist clinical data managers, clinical data assistants for allocated trials
  • Work closely with CROs contracted to perform data management functions
  • Support and assist with lab data review, SAE reconciliation, and third party data reconciliation
2

Clinical Data Manager Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical data manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical data manager
  • Mentor team members and more junior staff
  • Manage data management components of project and study budgets and vendor performance
  • Collaborate with CRO and study team members to identify and resolve issues impacting goal attainment
  • Provide Data Management expertise to the teams in customer oriented point of view Leads development of Data Review Plans
  • Manage CRO and study team members to identify and resolve issues impacting goal attainment
  • Develop eCRF design requirements
  • Works with external groups, including data management CROs, laboratories, clinical trials centers and contractors regarding data management needs, and anticipates logistical issues of acquiring data from a variety of sources
  • Ensures consistency, integrity and completeness of clinical databases by ensuring data management CROs, sites and other vendors are delivering quality data and documentation on time and according to quality standards
  • Performs routine data review to ensure quality and identify data trends/issues
  • Serves as the contact person and technical resource for CPMs on issues related to database design/implementation and data management processes arising during the execution of a study
Qualifications for clinical data manager
  • 10 years data management experience, or B.S
  • Undergraduate university Degree (4 year program), or equivalent experience
  • Requires a minimum of 6 – 10 years of related work experience with a solid understanding of Clinical Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS) and Clinical Research Data Management or equivalent
  • Implementation of FDA Title 21 CFR Part 11 Compliant Data Systems
  • Implementation of Electronic Data Capture for Clinical Studies
  • Implementation of Clinical Trial Management Systems for Clinical Studies
3

Clinical Data Manager Job Description

Job Description Example
Our company is hiring for a clinical data manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical data manager
  • Contributes to the development, implementation and compliance to standard operating procedures (SOPs), work instructions (WIs) and guidelines regarding data management
  • Coordinates resources to ensure all activities are completed in a timely manner
  • Explores new technologies for clinical data acquisition and processing
  • Leads in database build and UAT
  • Develops and executes data validation specifications and programs for assuring the accuracy of clinical trial data, , data review guidelines, computerized edit check programs, Data Management Plans (DMP)
  • Supports CTM in coordination of receipt of all ancillary data safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock
  • Participate in SOP development, training, process mapping, and other departmental activities
  • Serve as lead CDM on assigned clinical trials
  • Manage centralized dictionary coding of clinical data to MedDRA and the World Health Organization Drug Dictionary
  • Monitor activities / tasks vs
Qualifications for clinical data manager
  • Broad knowledge and application of business concepts, procedures and practices
  • Intermediate working knowledge of MS Office, SAS and JMP
  • Strong decision-making skills and ability to prioritize
  • Demonstrated ability to coordinate and monitor the quality of research data collected
  • Experience in managing and leading DM staff, including contractors and vendors
  • Knowledge and experience with various clinical databases and key technologies (e.g., EDC, scanning/imaging, CTMS, IVRS/IWRS, CDISC)
4

Clinical Data Manager Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of clinical data manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical data manager
  • Writes, updates/reviews and approves all required trial data management documentation
  • Able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
  • Able to support several clinical studies with minimal guidance
  • Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
  • Develop data edit check specifications and run data listings as required
  • Able to review and provide feedback to the clinical team on other study documents Clinical Monitoring plans, Statistical analysis plans and vendor specifications
  • Able to maintain study workbooks and data management files
  • Provide input into the development of data management SOPs, Work Instructions, and process documents
  • Configure, migrate, and test EDC databases based on internal procedures, approved requirements and system best practices
  • Perform coding of verbatim terms
Qualifications for clinical data manager
  • Technically astute with ability to understand programming logic concepts
  • Strong interpersonal, communication, organization, critical thinking, and problem-solving skills
  • 3-5 years of clinical data management experience 1+ years as a lead data manager
  • Experience defining, entering, processing, reviewing and validating clinical data
  • Proficient implementing and operating the EDC product Medidata/RAVE
  • Demonstrate initiative, sound judgment and flexibility
5

Clinical Data Manager Job Description

Job Description Example
Our innovative and growing company is looking for a clinical data manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical data manager
  • Identify improvement related to departmental processes
  • As necessary, provide work direction, guidance, mentoring, influence and support to junior staff
  • Demonstrates a passion for learning, sharing and discovering new information
  • Considers the vision, direction and goals of the organization when setting business or work priorities
  • Establishes a model for excellence and achieving objectives
  • Communicate with other team members, report issues, and coordinate data management related team meetings
  • Perform other data management functions as necessary
  • Develop project-specific data management plans that address areas such as reporting and work flow processes
  • Construct user tools for receiving, processing, or tracking data
  • Process clinical data, including receipt, entry, verification, or filing of information
Qualifications for clinical data manager
  • 1+ years’ experience in comparable position within the pharmaceutical, biotech or CRO industry recommended
  • Strong working knowledge of the Study Data Tabulation Model and the creation of data mapping specifications and annotated CRFs
  • At least two years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
  • Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors
  • Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, ) and their application to Data Management practice
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, with external partners and vendors

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