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How to move to independent consulting in clinical operations

The timing of your move is crucial to your success.

Clinical operations requires a complex mix of management and interpersonal skills, and considerable content knowledge in clinical research - so many moving parts!

If you work in the pharmaceutical industry in clinical operations in a niche such as a clinical research associate, you could make the transition 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.

To be an independent consultant, though, 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 is necessary. Those who arrive in industry with a background such as a nurse who is a clinical study coordinator are at an advantage compared with those who arrive with a degree in biology and no previous clinical research experience.

Typically, the people who work in clinical operations have a degree in biology, nursing, or pharmacy. In some cases they are physicians.

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

Clinical operations managers are expected to:

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

  • 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

  • Anticipate logistical problems that may hamper studies.

  • Help to develop and contribute to protocols, annual safety reports, clinical study reports, publications/presentations and regulatory submissions.

  • Prepare or review other study-related documents, such as informed consent forms, pharmacy manuals, laboratory manuals, study operations plans, monitoring plans, case report form (CRF) completion guidelines, study tools/worksheets and other study-specific documents or manuals.

  • Develop clinical operation timelines and budget forecasts

  • Identify, select and oversee contract research organizations (CROs) and vendors.

  • Review master service agreements, statements of work, and quality agreements relating to clinical operations.

  • Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of standard operating procedures (SOPs) and ensure that clinical trials comply with regulatory requirements and are ready for audits and inspections.

  • Manage study budgets and oversee vendor and site payments. This includes working with the company's finance department on budget expense projections and payment reconciliation, and reviewing and approving clinical invoices against approved budgets.

  • Review and sign off on monitoring reports, ensure study issues are addressed in compliance with study management plans.

  • Review operational components of legal documentation and statements of work for sponsors, vendors and suppliers.

  • Make sure trial reporting requirements of partners, such as pharmaceutical companies, are fulfilled.

  • And more!

As I physician in the area of clinical development, I have worked closely with clinical operations people. The managers perform a remarkable juggling act. Most impressive is the way they keep track of so many moving parts. Besides what I mentioned above, I greatly enjoyed working on working on meetings with clinical operations people to train investigators.

How go gain the necessary knowledge and experience.

Well-qualified people need time to develop the necessary knowledge, and considerable hands-on work in clinical operations to reach the level that they could leave industry and become independent consultants as comprehensive managers. For most people in clinical operations, I think it would take at least 5 years of experience in industry, with at least 2 or 3 years of managerial experience. More experience is better. When you have accumulated 7 to 10 years in industry, the transition would be easier.

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 components of your job.

Take relevant courses. Courses on clinical development, regulatory affairs, project management, and increasing your skills in using word processing, spreadsheets, Gantt charts, and clinical databases will be helpful. Courses on budget management would also help. Learning Tree International has courses on project cost and management, advanced use of Excel, and other areas relevant to clinical operations. Learning about safety reporting, clinical trial design, quality assurance and other aspects that factor into managing clinical trial would also be useful.

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

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

Some clinical operations managers I have worked with also obtained Master of Business Management (MBA) and other degrees related to management in the health sector.

Keep up to date in your field by attending conferences.

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

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.

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

Be clear about your niche and expertise. What would you offer to prospective clients?

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?

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

You could, in any event, get started on establishing a business structure, so that you are ready to make a seamless transition. See the Get Started page this website. Also, see: So you want to be a consultant? and Learning about consulting.

What are your thoughts?

Please give comments!

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