Clinical Data Manager Job Description

Clinical Data Manager Job Description, Skills, and Salary

Get to know about the duties, responsibilities, qualifications, and skills requirements of a clinical data manager. You can use our job description template in this article to produce your own. We also provide you with information about the salary you can earn as a clinical data manager.

 

Who is a Clinical Data Manager?

Clinical data managers are responsible for ensuring that clinical trials undertaken by pharmaceutical companies, manufacturers of medical devices, and other research-based organizations comply with all relevant laws. They also manage information flow between clinical trial locations, researchers, sponsors, and other stakeholders.

They usually use specialized software tools to organize and analyze clinical trial data to find patterns or issues that could jeopardize a study’s validity.

In addition, they oversee clinical data management (DM) activities such as establishing the complete data pipeline, building and maintaining clinical databases, and educating end users. They work closely and independently with various internal and external clinical trial partners, including clinical scientists, biostatisticians, and personnel from clinical sites.

 

Clinical Data Manager Job Description

Below are the clinical data manager job description examples you can use to develop your resume or write a job description for your employee. Employers can also use it to sieve out job seekers when choosing candidates for interviews.

The duties and responsibilities of a clinical data manager include the following:

  • Working with the clinical research team to monitor progress to protect data integrity throughout trials.
  • Resolving disagreements and communicating with researchers.
  • Evaluating study outcomes for quality and completeness.
  • Reviewing study protocols to make sure they adhere to regulatory requirements.
  • Coordinating with IT personnel to ensure data collection tools are functional with current systems.
  • Guiding clinical research workers regarding study methods and procedures.
  • Communicating with outside suppliers regarding the status of the research to keep them on track with their deliverables.
  • Maintaining communication with external organizations, such as research or regulatory bodies institutions, to conduct internal studies.
  • Observing the safety of research participants.
  • Informing the study director or other pertinent employees of any concerns.
  • Coordinating with other departments to ensure they have all the information required to support the study, such as marketing or sales.
  • Examining the data for irregularities and other issues that could jeopardize the study’s validity.
  • Managing requests for clinical data efficiently.
  • Acting as the primary point of contact for all issues relating to data.
  • Liaising with external websites and suppliers to ensure timely and accurate data collecting.
  • Verifying that case report forms (CRFs) are accurate, comprehensive, and compliant with the research protocol and applicable legislation.
  • Creating and maintaining the clinical trial master file (TMF).
  • Participating in inspections and audits conducted by sponsors and regulatory bodies.
  • Teaching new hires about data management best practices and processes.
  • Observing market developments and trends.
  • Performing further tasks that are necessary.

 

Qualifications

The qualifications of a clinical data manager include the following:

  • Bachelor’s degree in computer science, health informatics, or a related field
  • A minimum of five years of experience managing data for clinical research studies
  • Ability to program in SAS with ease.
  • Knowledge of managing a group of data managers
  • An in-depth background in creating and validating edit checks.
  • A highly analytical approach to communication and problem-solving.
  • Knowledge of other statistical software packages (SPSS, R)
  • The ability to organize and interpret voluminous data.
  • The ability to explain difficult concepts in straightforward language.

 

Essential Skills

Clinical data managers need the following skills to remain relevant in this field:

  • Data Analysis:

As a clinical data manager, you analyze clinical trial data to evaluate whether the treatment was effective or needed improvement. Additionally, you can be in charge of carrying out data analysis for legal compliance.

Data analysts further use this data to estimate future outcomes, which can aid in directing corporate decisions.

  • Organization:

The ability to stay on top of many tasks and obligations is an organizational ability those in this career path possess. For example, you should oversee multiple initiatives simultaneously as a clinical data manager. Strong organizational abilities allow you to efficiently manage your time and ensure that every component of your job is completed. Additionally, having a tidy workspace can make it easier for you to find documents.

  • Reliability:

Clinical data managers need to be reliable to thrive in their job. As a clinical data manager, you must be dependable and prompt when performing assignments or duties. You must also be trustworthy for your coworkers to entrust you with their most private information and resources. Being dependable will help you build long-lasting relationships at work and maintain a high level of productivity.

  • Attention to detail:

Clinical data managers must ensure that the patient data they enter into databases is correct and comprehensive. In addition, they carefully read the fine print in reports from other departments to ensure that their records match those of the different departments.

  • Problem-solving Skill:

The ability to identify and address issues that arise in a professional situation should be seen in all clinical data managers. This is needed because you have to deal with concerns about preserving patient privacy or ensuring compliance with regulations controlling medical records as a clinical data manager. By using problem-solving skills, you may get beyond these obstacles and ensure that your company upholds high levels of care.

  • Flexibility:

As a clinical data manager, you might need to modify your plans or objectives immediately. For instance, if an employee calls to inform you about any emergency which led to their absence from work, and you need to fill their job, you might need to adjust your workweek to ensure that all of your projects are completed on schedule. Being adaptive will help you fulfill deadlines and maintain a healthy work-life balance.

  • Technology:

Data managers must be familiar with the most recent technological advancements to perform their duties. To store and organize patient data, they must be able to pinpoint the most practical and efficient technology. They must also be able to resolve any technical problems that might impact patient data.

  • SQL:

Data managers use the SQL programming language to store and retrieve data from databases. To manage the massive amounts of data produced by medical research studies, clinical data managers must be familiar with SQL. They can also create reports with specific information on the characteristics of patients, the courses of treatment used, and the results.

  • SAS:

Using statistical analysis tools is a vital competency for a clinical data manager. You must be knowledgeable in computer science and statistics because this work calls on you to understand and analyze a large amount of data. Keeping up with these advancements might be beneficial because you need to train yourself on new applications as technology advances.

  • Medical Knowledge:

Understanding medical terms and procedures are referred to as having medical knowledge. Having medical knowledge is crucial because clinical data managers frequently deal with medical data and information. Therefore, clinical data managers can better interpret and comprehend the data’s meaning if they have a basic understanding of medical procedures.

  • Project Management:

By employing project management techniques, clinical data managers may oversee complex initiatives and guarantee that all team members can access the materials they need to do their tasks. This can entail scheduling project deadlines, assigning tasks to workers, monitoring worker performance, and determining overall success. As a result, teams with good project management are more efficient, meet deadlines, and are less stressed at work.

  • Analytical Skills:

Clinical data managers use their analytical talents to review and interpret data. They look at the data to determine whether it complies with organizational criteria, whether it is correct, and whether any trends or patterns could aid in the future improvement of operations. This necessitates having the ability to examine the available data as well as paying close attention to detail.

  • Communication Skill:

Communication is the ability to deliver information in a way that other people can understand. As a clinical data manager, you might have to communicate with many teams or departments within a company. To do this, you must clearly state what you need and why. Understanding others’ needs also requires listening.

 

How to Become a Clinical Data Manager

A career in clinical data management can make innovative use of your medical education and skills. To become a clinical data manager, follow the steps listed below:

  • Step 1: Earn a degree:

You must first obtain a college degree in data management or information technology before you can work as a clinical data manager. Throughout your education, you will take science, research methodology, pharmacology, biology, and ethics courses. A bachelor’s degree is sufficient for entry-level positions, though some employers may also insist on completing graduate-level computer or life sciences coursework.

  • Step 2: Acquire relevant experience:

Most potential employers will also expect you to have some prior work experience. Typically, clinical data managers can obtain this work experience through an internship program sponsored by a college.

It is essential to have a working understanding of data management software in addition to a college degree. Additionally, you need to be familiar with platforms for computer programming, like Structured Query Language. Furthermore, it is helpful to have some programming experience with the Statistical Analysis System platform before working as a clinical data manager. Although programming skills are not required for work, they could be helpful when carrying out your obligations. You might become more appealing to potential employers if you have these computer programming talents.

  • Step 3: Get Certifications:

You may also pursue a professional qualification before beginning employment in clinical data management. For instance, applicants who meet specific requirements might receive professional certification from the Society for Clinical Data Management in the United States. Before you can sit for the exam, you require a bachelor’s degree and two years of relevant professional experience in clinical data administration. In addition, a bachelor’s degree will be accepted by society in place of an associate’s degree and three years of work experience. However, it is optional to have a college degree to take the certification exam if you have four or more years of experience managing clinical data.

Certifications demonstrate a clinical data manager’s knowledge of and commitment to the field. Some of these certifications include but are not limited to the following;

  1. Certified Data Management Professionals (CDMP):

The nonprofit Global Data Management Community offers this certification at four levels: Associate, Practitioner, Master, and Fellow. Additional expert tests are available in other disciplines, such as data modeling and quality.

  1. Certified Analytics Professional (cap):

Suppose you have a bachelor’s degree, five years of professional data analytics experience, or a master’s degree and three years of work experience; in that case, you can take an assessment to become a Certified Analytics Professional (CAP). Every three years, members must renew their CAP certification.

  • Step 4: Search for Jobs:

Make use of your networks and job-search resources, both online and offline. Requirements and other instructions should be carefully studied before submitting applications to various employers. Create a cover letter highlighting your qualifications for the post and a CV customized to each job description. After applying, you can update your professional profiles on multiple platforms and create a spreadsheet to keep track of the applications you’ve sent in and the interviews you’ve been asked to. Using a different personal email address is advantageous for the best outcomes.

  • Step 5: Stay up to date with the most recent advances in technology:

Because technology is constantly changing, clinical data managers must keep up with the latest innovations. In addition, new software and systems must be acquainted with clinical data managers due to the possibility of their usage in clinical trials. They must also understand how contemporary technologies might assist the study process.

For instance, electronic medical records (EMRs) are increasingly used in healthcare settings. EMR-savvy clinical data managers can help by ensuring that patient data is entered into the system appropriately.

  • Step 6: Join professional groups like the Drug Information Association (DIA):

Clinical data managers can receive training and accreditation from the Drug Information Association (DIA). By joining the DIA, you may network with other professionals in this field and stay up to date on industry standards.

The DIA offers several certificates for clinical data managers, including one designed especially for senior clinical data managers. Getting a DIA certification can help you enhance your career by displaying your subject-matter expertise and differentiating you from the competition.

 

Where to Work as a Clinical Data Manager

Clinical data managers work for various organizations, including hospitals, pharmaceutical companies, and academic institutions. Although they usually work during regular business hours, they occasionally have to stay late or work on the weekend to meet deadlines. Clinical data managers can operate independently or collaboratively with other professionals such as physicians, statisticians, and computer programmers. They can be found in laboratories even though they often operate in offices or cubicles.

 

Clinical Data Manager Salary Scale

Clinical Data Managers can anticipate annual salaries ranging from $106,599 to $129,338. However, your location, work level, experience, education, and talents could influence a clinical data manager’s salary.

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