Clinical project managers are under extreme pressure to have diverse groups of people perform and meet deadlines according to industry standards. As a clinical project manager it can be challenging to motivate and get groups to meet deadlines since they don't report to you. Generally you are working in a dotted line matrix environment who are direct reports to other managers who have priorities that may differ from yours. Another thing is that each person that represents each division on your team is the expert in regulations and guidelines theoretically, but you are responsible to make sure they know the regulatory and clinical requirements. Timelines are critical and this ties back to the team representatives priority list. Your job is to negotiate time to allow them to get what you need done to meet your project needs completed. Setbacks are inevitable and often invovle costs. Staying within budgets is another challenge. You have to negotiate budgets within and outside of your company, sometimes with external consultants or CROs. You can't really slash costs if the FDA mandates specific study data your company has not collected. While you don't need to be an expert in statistics, regulatory, and clinical you need to know enough to be confident your projects sections are in compliance and that you understand the content and requirements for each section before filing INDs and NDAs. If you don't have the expertise you need to know who to call on for confirmation of accurate reports or clarification of data. You need to understand the needs, requirements, and compliance issues well enough to keep your timelines and stay within budget. You need to have excellent negotiation skills and provided incentives to keep your team on track. Missed milestones cost the company a lot in dollars. Getting a product to market on time or ahead of time is a feather in your cap. That's my 2 cents. I would like to hear what other have to say.