How to Start and Grow Your Clinical Trial Manager Career
Clinical trial management is an exciting and important role within the clinical research industry, which provides innovative medical advancements for patients to have options in their healthcare. As a Clinical Trial Manager (CTM), you play a critical role in overseeing clinical research studies, ensuring they run smoothly, ethically, and efficiently. If you're a current or aspiring CTM, here’s a comprehensive guide on how to start and grow your career as a Clinical Trial Manager.
Understand the Role
Clinical Trial Managers are the hub of the internal and external study teams, so the CTM responsibilities are important to ensuring clinical trials are operationally successful. CTM responsibilities will typically include:
Study Planning: Developing study protocols , study documents, and timelines. Typically this is in partnership with the sponsor leadership team, medical writing team, and clinical development team.
Team Coordination: Leading cross-functional teams including the sponsor team, CRO and any other vendors, investigators, and regulatory bodies.
Budget Management: Overseeing study budgets and resource allocation. Typically this is in partnership with the sponsor finance team.
Timeline Management: Overseeing study timelines. This may be in partnership with the sponsor Program Management team.
Quality & Compliance Oversight: Ensuring adherence to regulations and ethical standards. Typically this is in partnership with the sponsor Clinical Quality Assurance (CQA) team.
Data Analysis: Reviewing study data to ensure accuracy and validity. Typically this is in partnership with the sponsor Data Management and Biostatistics teams.
To learn more about the expected responsibilities of a CTM, do a quick LinkedIn search for CTM jobs and review the job descriptions. JDs will differ slightly based on the needs of each company, but it will give you a good idea of the general expectations.
Educational Background
Relevant Degrees
While degrees (e.g., Bachelor’s Degree, Master’s Degree) may help you to get your foot in the door, I haven’t seen consistent requirements for degrees at the level of a CTM and I have known several people grow to top leadership positions within clinical trial management without these advanced degrees.
Certifications
While not mandatory, specialized certifications can enhance your credentials. when you are just starting out in your CTM career. Consider the following:
Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates (SOCRA)
Project Management Professional (PMP) from the Project Management Institute (PMI)
Clinical Project Management Fundamentals from Barnett International
These certifications not only improve your knowledge but also demonstrate your commitment to the continuing education in the industry.
Gain Practical Experience
If you’re an aspiring CTM, consider starting in an entry-level role in clinical research. Positions like Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) can provide valuable hands-on experience. at sites and CRO companies. You’ll learn about study protocols, patient recruitment, and data management, all of which are important skills for a future CTM role. There are also a diverse variety of other roles at site and CRO companies, so be open minded to explore roles that are a stepping stone to the CTM position.
If you’re a current CTM and you’re interested in growing to a Senior CTM role and beyond, understand CTM expectations and focus on becoming a high-performer in your current role. Over-deliver on your current responsibilities and find ways to gain visibility for your hard work in your department. Before expecting a promotion, make sure leaders know your name and your demonstrated history of adding unique value to your company.
Develop Key Skills
Clinical Trial Management
Being proficient in clinical trial management acronyms, study phases, common systems (e.g., TMF, EDC, CTMS), and cross-functional expectations and responsibilities, creates a solid foundation for navigating your day-to-day responsibilities and conversations.
Once clinical research basics are mastered, there are specific skills that CTMs must know to do the job well. Skills include but are not limited to: study budgets (creating a budget, change orders, billing/invoicing), study timelines, quality and inspection readiness, data cleaning and analysis, site management and monitoring, patient recruitment and engagement, CRO and vendor selection and oversight, DSMB/IDMC management, study start-up/maintenance/close out responsibilities, site contracting, developing protocols and implementing protocol amendments, protocol deviations, and establishing study plans. To learn all of these skills and more, check out The High-Performing Clinical Trial Manager course., the industry’s only course designed to teach CTMs the highest impact skills to be successful.
Project Management
Strong project management skills are essential. Familiarize yourself with tools like Microsoft Project or Asana (check out more information here) and learn about Agile methodologies, as these will help you manage timelines, budgets, and team communication effectively.
Communication
As a CTM, you’ll need to communicate clearly with a diverse group of stakeholders. Practice both written and verbal communication skills, focusing on clarity, persuasion, and active listening. For tips on relationship management and managing up in your organization, download the free guide: 4 Habits of A High-Performing Clinical Trial Manager.
Regulatory Knowledge
Understanding the regulatory landscape is critical. Stay updated on Good Clinical Practice (GCP), FDA regulations, and other relevant guidelines. This knowledge will help you navigate the complexities of clinical trials.
Build Your Network
Networking is key to accelerating your CTM career. By building an intentional network of peers and leaders in the clinical research industry you will have colleagues within and outside of your company to bounce ideas off of, do industry research with, experience job security by having access to opportunities and referrals, and have greater satisfaction by being connected.
Build your network by attending industry conferences, joining professional organizations, participating in local and regional networking groups, and engaging with peers on platforms like LinkedIn.
Find A Mentor
From entry-level to top leadership, having a mentor offers many benefits that can significantly impact personal and professional development:
Guidance and Support: A mentor provides valuable insights and advice based on their own experiences, helping you navigate challenges and make informed decisions.
Skill Development: Mentors can help you identify and develop key skills, offering resources and strategies for improvement.
Networking Opportunities: Mentors often have extensive networks and can introduce you to influential contacts in the industry, opening doors to new opportunities.
Increased Confidence: With a mentor’s encouragement and feedback, you may gain more confidence in your abilities and decision-making.
Accountability: Having a mentor can help keep you accountable for your goals, providing motivation to stay on track and achieve them.
Perspective: A mentor can offer a fresh perspective, helping you see situations from different angles and encouraging critical thinking.
Personal Growth: Beyond professional skills, mentors can help you develop soft skills like communication, leadership, and emotional intelligence.
Career Advancement: Mentorship can be a catalyst for career growth, helping you identify opportunities and prepare for future roles.
Long-Term Relationship: The mentor-mentee relationship can evolve into a lasting connection that provides ongoing support throughout your career.
Emotional Support: Mentors can provide encouragement and understanding, especially during tough times, making the journey feel less lonely.
Stay Informed and Continue Learning
The clinical research landscape is constantly evolving, with new advancement, technologies, regulations, and more. Stay informed by:
Following industry leaders on LinkedIn to stay in the know about innovative companies and results-oriented leaders.
Reading industry journals and articles.
Participating in industry webinars and workshops.
Enrolling in continuing education courses related to your subject matter expertise.
Enjoy The Journey
Starting and growing a career as a Clinical Trial Manager is a rewarding journey filled with opportunities to make a significant impact in healthcare for patients. As you build a solid foundation, develop essential skills, and position yourself for long-term success, be sure to celebrate your growth and have fun along the way. Career advancement is a marathon not a sprint, so stay curious and find people who will support you and cheer you on a long the way!
