Dont Worry About the Job Title

05-24

來自專欄我不是煎茶猿

By: Patrick Stern, CCDM, Director, Clinical Data Management, Agensys Inc, an affliate of Astellas, Inc.

It was early in my career in Clinical Research -working as a SAS programmer at the time - when a recruiter called me about a position in Clinical Data Management (CDM). As he was describing the job, I asked him about the job title. "Dont worry about the job title," he replied. His response gave me a moment to reflect about what my career plan was and how I was approaching it.

I dont think I need a survey to ask how many of us while in college had a plan to become a "clinical data manager". If its not a degree, what led us here? What did we do that had others select us for this role? Now that were in it, what moves us through a career in, out, and through CDM? I will share my perspective on our dynamic industry, including the skills and experience important to career growth, as well as how your approach to the feld can make the biggest difference.

Change Really Is Constant

Careers in, out and through CDM will not follow a nice straight path. It is the nature of todays business environment and our clinical research industry to be in continuous re-organization. The mixture of in-house versus outsourced models, changing technology, and the sizing of CDM departments are among the many factors defning CDM jobs. There are many external influences, so it is especially important to balance your expectations as far as constant promotions or linear job title changes are concerned.

A career, by defnition, is a long-term occupation in life. When we look over 10, 20, 30, and yes maybe even 40 years, seeking a promotion every few years is unrealistic. Your growth into new roles and leadership positions will develop naturally as you develop a breadth of experience in the work you do. Despite the ever-changing organizational charts, job titles, and various roles and responsibilities, it will be your skills, experience, and attitude that will drive your career. What seem like lateral shifts or title changes are actually what adds depth to your resume.

Solid Foundations

Careers in CDM begin with the same skills expected of any clinical research job. Skills such as attention to detail, understanding requirements, ability to follow defned processes, and performing good documentation are essential. These may sound like cliché attributes, but a successful data manager should be able to dive into the detail and be able to follow/create logical process flow documents so that others can understand what was done. So, if you dont shy away from large documents, performing thorough QC checks, or having 「yet another form to complete,」 you are on the right track. Having technical skills in CDM is the next requirement.

Most jobs in CDM will require working with databases and electronic systems. This doesnt mean, however, that you have to have a computer programming background. Yes, some jobs may require specific programming skills such as SQL to program edit checks or create reports, but dont let that scare you off just yet. Many software applications are designed to be used by those without a programming background. Much of the programming needed for edits or reports can be learned quickly on the job. What matters with these technical requirements isnt always the specifc system (remember, they are constantly changing anyway). Its really about your ability to have the previously mentioned solid foundations.

Working with CDM systems comes down to a willingness to dive into a process flow and see the requirement details while learning the steps that then build upon and support the next steps. Thus with changing EDC systems, expertise is really built from a commitment of time to fully understand the workflow. This, combined with a willingness to do the sometimes tedious QC checks between protocol, specifcation documents, and text or data output, will have you performing the steps required to ensure data integrity before you know it. The skills you use and the general workflow you learn can be applied to any system.

Embrace the New

Growth in any career comes as a result of learning new things. CDM is no different. Every organization will have special projects or different job roles with specific functions. Embrace the opportunities to take on an unfamiliar project or try a new role. It may start with a process improvement, general SOP work, or an area like medical dictionaries. Opportunities may even go beyond the scope of CDM into working with clinical, safety or other departments. A supportive and positive attitude toward any project can be considered as much a measure of your success as the actual skills youll develop while performing them.

It is also important to set aside time each week, even if its just 15 minutes, to read something from a professional resource. This can be an industry journal or SCDMs Good Clinical Data Management Practices (GCDMP). Even as job titles change around you and combine different elements of CDM, this will help prepare you to meet the challenges that come. Taking time to research industry trends in order to develop expertise about your current or new roles and functions will help you achieve career growth.

Build Yourself and They Will Come

Getting into CDM is about having a basic set of skills that apply to the job you want. The overall and specific system experience you have may be considered a plus, but the best measures of your ability and success are your attitude and approach to representing your skills. Any time you spend in developing new skills will help lead to career growth. Having real-world examples of applying your skills in multiple capacities will also help differentiate you from the competition. It wont be your current job title that gets you the next promotion or new position. It will be the skills you have and the experience you acquire along the way. These same skills will help propel your growth in any organization, including moving beyond CDM if that is your desire. Having developed yourself, the job titles and growth will follow your lead.

Patrick Stern has 15 years of experience working in CROs, medical device, and biotech companies. Patrick is currently Director of Clinical Data Management with Agensys, Inc. Its been a long and winding road getting here: Starting with service in the U.S. Air Force as a frefghter, getting a B.S. in Psychology, and beginning a career in clinical research working as a SAS Programmer. He is currently enrolled in an Executive MBA program with UCLA Anderson School of Management.