By Suresh Sharma
Wider EDC (electronic data capture) adoption has been driven by increased acceptance by large pharma. EDC has also helped expand the role of the clinical research associate (CRA) and the clinical data manager (CDM).
CRAs and CDMs of the 21st century operate in environments quite unlike those they first entered. They must regularly update their skills (clinical advancements, project management, technical, and behavioral) to meet the challenges of a dynamic global clinical research market that includes outsourcing and offshoring.
Pharma companies have always opted for EDC to carry out large multinational, multicenter clinical trials, primarily to improve quality of data, shorten study timelines, and reduce project costs. Advancements in technology that capture and manage volumes of clinical trial data from multiple sources have added more complexity to the processes involved in conducting an EDC study. Project teams must possess the necessary skills and competencies to handle these challenges.
A clinical development professional with a blend of both technical and clinical expertise, coupled with strong project management skills, can understand the complexities in handling EDC trials. These professionals are called “Tech(Cli)nical” Project Managers or “TCPMs.”
Who Can Become A TCPM?
Clinical research professionals and project data managers who have hands-on experience in most aspects of clinical data management and have managed the delivery of large global/multicountry and multicenter clinical trial databases are ideal candidates for the role of TCPM. TCPMs are seen mostly in pharmaceutical companies rather than CROs due to their exposure in handling multiple therapeutic areas, collaborating with third-party vendors for data transfers and data reconciliation, and working with clinical project teams on study inputs/amendments/modifications with stringent budgets and timelines for submissions to regulatory authorities.
Below are a few steps to help achieve becoming a TCPM.
Technical Skill Gaps
Technical skills in CDM can be improved by preparing to take certification exams such as Certified Clinical Data Manager (CCDM) offered by the Society for Clinical Data Management (SCDM) or Project Management Professional (PMP) offered by Project Management Institute (PMI). Additionally, skills can be honed by working on EDC trials, participating or leading the design and implementation of a tool/software that automates any clinical data management process, or by project managing a large Phase 3 trial that includes data handling with third-party vendors (IVRS, lab, ECG, CT scan, etc.).
Behavioral Skill Gaps
Behavioral skills can be enhanced by nominating deserving professionals to attend leadership development seminars and workshops. Skills can also be improved by providing opportunities to work on project teams that have different cultures, styles of working, communication, and time zones. It is often seen that participation in face-to-face project team meetings like investigator meetings, CRA trainings, and EDC setup meetings enables individuals to learn, adapt, and understand the behaviors and objectives of every stakeholder involved in making the project a success. Another networking forum where diverse cultures, thoughts, and ideas can be experienced is at international conferences and seminars organized by professional industry organizations.
Strategic Skill Gaps
Tactical skills can be enhanced by providing opportunities to review and give input into the department’s overall strategic plan. Taking a strategic priority that is hindered and brainstorming what changes could be made to the process and policy around it also aligns with strategic priorities. Reading industry and organizational business reports and summarizing information about current business trends for decision making helps gain corporate mileage.
So, after all this hard work, do you want to be a Technical PM, Clinical PM, or TCPM?
Suresh Sharma’s current role in Tata Consultancy Services (TCS) is offering owner-clinical data management in the business development team, and he also supports market research/business intelligence activities in the life sciences and healthcare verticals of TCS. He has been in the clinical data management business for more than 10 years, with prior experience in GlaxoSmithKline Biologicals and Quintiles in India.