How to move to independent consulting in clinical operations

Are you wondering how to move to independent consulting in clinical operations? Here’s what you need to know!

If you have the right experience, the opportunities are out there. The problem is how to make the move in to consulting.

“The most difficult thing is the decision to act. The rest is merely tenacity.”

Amelia Earhart

Here is what we will cover:

• The timing of your move is crucial to your success.
• What are the opportunities in clinical operations?
• How is the outlook for making a transition to consulting?
• The sheer magnitude and complexity of clinical operations shows the need for extensive knowledge and experience
• How to gain the necessary knowledge and experience
• So when you are ready to make the transition, what should you do?
• Conclusion

The timing of your move is crucial to your success.

Clinical operations requires a complex mix of management and interpersonal skills, and considerable knowledge of clinical research – so many moving parts! It takes time to become a real expert.

To be an independent consultant, who advises overall on clinical operations or serves as a leader of clinical operations, requires a strong background and quite extensive experience. So don’t make the move too early.

There are no fixed rules, but years of industry experience are necessary to be an independent consultant in clinical operations.

Your background makes a difference in how rapidly you can gain the best experience to become as a consultant. For example, nurses, who are clinical study coordinators are at an advantage over those who start with a degree in biology and no previous clinical research experience.

If you work in the pharmaceutical industry in clinical operations in a niche such as a clinical research associate, you could make the transition to independent consulting in clinical operations as described in another post. You could also work remotely under contract to support a company’s clinical operations department. You could do this at an earlier stage.

What are the opportunities in clinical operations?

“Your regrets aren’t what you did, but what you didn’t do. So I take every opportunity.” 

Cameron Diaz

Before moving into independent consulting in clinical operations it’s good to consider where you stand in among your peers working in the field. Also, how is the field of clinical operations itself doing?

• Is it a growing area or is it declining?
• Are the clinical trials that are your bread and butter on the rise or falling by the wayside?
• Is the pharmaceutical industry faltering or does it continue to have good prospects?

Let’s look at the current status.

Who works as clinical operations manager?

From a database of 30 million profiles, cross checked against Bureau of Labor Statistics, Census, and current job openings data for accuracy, Zippia found that there are at least 25,977 clinical operations managers employed in the United States and their average age is 44 years and 70.5% are female.

Since 2010, they note that the proportion of females rose from 65.08% to 70.5% and in 2021 women earned 90% of what men were paid with women’s average annual income at $81,910 compared with $90,864 for men. So, a significant pay gap remains. 

Clinical operations managers are for the most part White (67.6%), followed by Hispanic or Latino (15.1%), Asian (6.3%) and Black or African American (6.1%), and American Indian and Alaska Native, 0.6% according to Zippia.  For 4.3%, the ethnicity or race was unknown. As in the general population, the demographics of the clinical operations workforce are increasingly diverse.

In my experience, some people in clinical operations in the United States are physicians. Elsewhere, such as in Eastern Europe and India, I met many doctors who worked in clinical operations, which appears to be more common in those countries.

Interestingly, Zippia also found that clinical operations managers are 68% more likely to work at private companies compared to public companies.  The number of jobs continue to grow for clinical operations managers.

According to Zippia, among clinical operations managers: 52.1% have Bachelors; 22.2% Masters ; 17.5% Associates degrees.  The most common degrees were nursing, business, health care administration, and psychology, but a third of people had other degrees. 

Many sources state a good background for clinical operations is a bachelors degree but to be a manager for a large organization, a masters degree is better.  They also recommend getting certified in areas relevant to clinical operations.

The bottom line

• Your peers are numerous, increasingly diverse, and are well educated with majority associate, bachelor or masters degrees.
• Jobs in your sector are growing

How many clinical trials are out there?

The number of trials is large

According to clinicaltrials.gov, the total number of clinical studies registered with them as of March 5, 2023 was 444,259.  Not all of these studies are clinical trials, but are clinical studies. 

While various regulatory authorities require or encourage registration of trials, not all sponsors register clinical trials in the world with clinicaltrials.gov. 

The rate of increase of new studies has been impressive

In February 2000, only 1,255 studies were registered and these increased progressively to the well over 400,000 trials in March 2023.

What this suggests that clinical operations opportunities will continue to increase.

More than half of trials are done outside the United States

Clinicaltrials.gov notes that:

• more than half (53%) of clinical trials registered with them are done only outside of the United States
• 31% are reported as being done in the US only
• 5% are both in and outside of the United States
• for 11% information was not provided. 

What could these numbers mean for jobs in the US? 

Well, many US companies do some trials that are only ex US, i.e., outside of the US.  Some companies outside of the US sponsor trials in America. So, the location of the trials does not tell you which country is doing the trials. 

For American clinical operations workers, since so many companies doing clinical trials outside of the country, experience with international trials is valuable and likely to become more important over time.

How well is the pharmaceutical industry doing?

“Global revenues from the pharmaceutical industry total 1.2 trillion dollars.”

According to market.us

Before moving to independent consulting in clinical operations, you should consider how well the pharmaceutical industry is faring.

Market.us notes that pharmaceutical revenues are flattening in developed countries. Companies there are looking for opportunities in emerging markets, such as Brazil, India, Colombia, and Egypt.  

The United States is still the global leading market for pharmaceutical products with:

• over $550 billion revenue in 2021
• 49% of global pharmaceutical sales in 2022.

After the United States, sales are greatest in Europe, then Asia, South America and the Middle East, where Saudi Arabia is the leader.

We can see from this that opportunities in the pharmaceutical industry are still attractive and jobs are likely to continue to expand. However, work may shift more to international studies or trials outside the United States. 

How is the outlook for making a transition to independent consulting in clinical operations?

Jobs for clinical operations managers appear to be growing.

From the large and still increasing number of clinical studies noted by clinicaltrials.gov, opportunities for clinical operations workers look promising. 

The pharmaceutical industry is expanding.

Now is a good time to make the transition to independent consulting in clinical operations.

The sheer magnitude and complexity of clinical operations shows the need for extensive knowledge and experience

What are your strong points for becoming an independent consultant in clinical operations?

You know what you do, but you can read this to think about the areas that are your strong points, or skip to the next section.

Employers expect clinical operations managers to:

Have to knowledge they need

• Have extensive knowledge of Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations, and International Committee on Harmonisation (ICH) Guidelines.

Manage many things

• Oversee and manage operations and people involved in clinical operations, data management, medical writing and other areas.
• Make sure clinical trials have adequate resources, follow timelines, and are conducted according to good quality practices.
• Participate in the review, planning and implementation of clinical trials

Read More

Clinical operations is a lot to learn and master.

How to gain the necessary knowledge and experience

“If you don’t like the road you’re walking, start paving another one.”

Dolly Parton

Take the time you need

Well-qualified people need time to develop the necessary knowledge, and a lot of hands-on work in clinical operations to reach the level that they could leave their jobs and become independent consultants.

For most people in clinical operations, it would take at least 5 years of experience in industry, with at least 2 or 3 years of experience in management.

More experience is better. When you have gained 7 to 10 years in industry, the transition would be easier to become an independent consultant in clinical operations.

Learn all you can about your job

If you are working in industry and planning to become an independent consultant at some stage, it is important to grow in your job, striving for excellence, and taking every opportunity to learn all the aspects of your job.

It is crucial to know your job extremely well before making the transition to independent consulting in clinical operations.

Take relevant courses

Professional Development Courses

These courses are to help you develop new skills and improve your job performance. They include areas such as leadership, communication, time management, and project management.

Courses on clinical development, regulatory affairs, project management, and increasing your skills in using word processing, spreadsheets, project management software, Gantt charts, and clinical databases will be helpful.

Courses on budget management would also be useful. Learning Tree International has courses on project cost and management, advanced use of Excel, and other areas relevant to clinical operations.

Industry-Specific Courses

As someone in the field, you would know about DIA and might be a member. They have many relevant courses.

Depending on your area of clinical operations, courses may be available that are relevant to your specific job. For example, if you work in clinical operations in oncology, there are courses available on this topic.

Learning about safety reporting, clinical trial design, quality assurance and other aspects that factor into managing clinical trials would also be useful.

The FDA has considerable information on their site including training and continuing education and webinars.

PERI has good courses on clinical development.

It is worth searching online for courses relevant to your situation.

Online learning platforms

These include Coursera, Udemy, LinkedIn Learning, and others that offer a multitude of courses on different topics. These courses are often self-paced and can be taken from anywhere, which is a convenient option for busy professionals.

Certifications relevant to clinical operations

You may be a member of the Association of Clinical Research Professionals (ACRP) which offers relevant certification examinations. The Society of Clinical Research Associates (SOCRA) also has courses and certifications.

University degrees

Some clinical operations managers I have worked with also got Master of Business Management (MBA) and other degrees related to management in the health sector. Here is information on some Master’s degrees in health clinical research.

Keep up to date in your field by attending conferences.

Professional organizations and industry associations offer continuing education courses that can help you stay up to date on the latest trends and best practices in your field.

Learn from accomplished people

“Tell me and I forget, teach me and I may remember, involve me and I learn.”

Benjamin Franklin

It is also important to learn as much as you can from good managers. Find a mentor. At a practical level, they have learned the necessary elements and tricks of the trade to perform well.

If you have opportunities for shadowing people or rotating within your department, you should take them. Some companies have fast track leadership programs, where they have talented people do exactly that.

Read academic and industry publications and blogs to keep up to date and to learn from accomplished people outside of your organization.

Take on new projects to add greater breadth and depth to your experience.

Get feedback from your supervisor, peers and subordinates to improve your performance.

Basically, the point is not that you have to do all of these many things, but that doing what you can to increase your knowledge and skills is important.

Considering carefully what you need to learn will go a long way toward preparing you to become an independent consultant in clinical operations.

So, when you are ready to make the transition, what should you do?

“Even the greatest was once a beginner. Don’t be afraid to take that first step.”

Muhammad Ali

Be clear about your niche and expertise.

What are you:

• providing as areas of expertise?
• offering to prospective clients?
• good at?
• known for? (It’s best to lead with your strengths.)

List all your areas of relevant knowledge and experience. Think about the skills you possess, the industries and settings you have worked in, and the problems you have solved in the past.

What is the market for your services?

Now research the market to determine which areas are in demand. Look for areas where businesses are struggling to find solutions or where there is a lack of expertise. Who is your competition?

Who are your ideal clients?

Think about the types of clients you want to work with. Consider the size of the business, the industry, and the problems for which they need your help. This will let you further narrow down your niche.

What is your unique value proposition?

Form a unique value proposition that sets you apart from other consultants in the market. Identify the specific benefits that you can offer your clients and how you can help them achieve their goals.

Check your niche

Before locking in your niche, validate it out by offering your services to a few clients. This will help you refine your approach and determine if your niche is a good fit for your skills and experience.

These steps will help you to delineate your niche as a consultant and position yourself as an expert in your field.

These questions can be early steps in establishing your brand. Still not sure how to build your brand or need more detailed information? See this excellent article by Sonia Gregory: 11 Simple Steps for a Brand Building Process.

Think of who would want your services.

Would your current employer want you to consult for them?

Are you aware of opportunities elsewhere?

Would big pharma or startup companies or CROs be most interested in your services?

Who your best customers are will also be part of establishing your brand.

How would you find clients and how would they find you?

I have written about this in these articles: Consulting: How to find clients and From unknown to in-demand: How to market yourself online as an independent consultant or freelancer. These articles also both look at how clients would find you.

Make the transition while you still have a job

Learn more about consulting

Also, see: So you want to be a consultant? and Learning about consulting for more information relevant to making the transition into consulting.

Work on your consulting skills

To develop your consulting skills, see How to improve your consulting – Deliberate practice?

Start consulting

“You can’t be that kid standing at the top of the water slide, overthinking it. You have to go down the chute.”

Tina Fey

If you can, and your employer allows it, you could transition to consulting on your own time, while staying in your job.

Starting to consult while you are still working will give you an opportunity to test the waters.

If you are sure that you will make the transition to consulting, it would be better to establish a business structure first and register your business in your state.

Get started on establishing a business structure

This will help you are ready to make a seamless transition. See the Get Started page on this website to understand what you need to know about business structure and how to set up a business. For women, consider at this stage, whether to pursue Women Owned Small Business (WOSB) certification through the Small Business Administration. This can improve competitiveness for women who are establishing or growing small businesses.

Conclusion

Follow the steps outlined in this post, become an expert, and prepare well to make a smooth transition to consulting in clinical operations.

“The greatest danger to our future is apathy.”

Jane Goodall

See this post on ChatGPTs responses on independent consulting in clinical operations.

What are your thoughts?

Please give comments!

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