Outsourcing strategies have evolved from being very tactical in nature with clearly defined, transactional service statements to a much more strategic approach. This evolution has shifted the expectations between client and CRO, particularly on project managers (PM). At the same time, clinical studies have become significantly more complex due to ever-changing regulations, the implementation of innovative technologies, a challenging recruitment environment and the need to manage larger and more complex project teams. All these trends have a meaningful impact on the PM role.
PMs traditionally have been perceived as process administrators while managing teams under direct supervision of the client. What PPD has observed and is adapting to is the need for our PMs to provide strategic leadership, with an understanding of the bigger picture of the overall drug development plan, and be the “CEO” on the project in order to provide successful outcomes and to create new opportunities for clients.
With the adoption of ICH E6 R2 (good clinical practice guideline) in November 2016, PMs need to invest in a more formal, proactive risk management strategy. There needs to be a mind shift from purely focusing on operational risks to a more holistic view including characterizing critical data and processes and in identifying any risks impacting subject safety or data integrity to support a total quality approach throughout the life cycle of the project.
With the implementation of sophisticated predictive analytic tools, project data is available at our fingertips. As such, there has been an increased demand on a PM’s ability to demonstrate proficiency in data analysis to identify project risks and opportunities over the life of the project.
Innovation in the clinical trial industry is a must to ensure life-changing therapies get to patients faster with a high return on R&D investments. The PMs and their project teams can no longer work with what once were considered gold standards. PMs need to be agile to:
- Adjust based on anticipated future needs
- Be creative
- Always strive for better solutions and adopt innovations that present themselves
Communication always has been a core skill for PMs. However, in order to be true influencers and establish successful internal and external relationships, PMs should be up to date with market trends to effectively manage business value. The successful PM will drive decisions and understand how to take calculated risks to maximize opportunities for stakeholders.
Due to the new challenges PMs are facing, we believe line managers and CRO business leaders need to emphasize three key areas: people, systems and processes.
- Investments in employee engagement, including increased opportunity for development and strengthened connections, are essential.
- Establishing effective support functions and leading-edge technologies, like data analytic platforms, to support PMs in their day-to-day job and reduce administrative burden need to be employed.
- Focus on lean processes, agile learning opportunities and adequate just-in-time training is a necessity to enable PMs to embrace change.
Clearly, change is a constant in the biopharma industry and clients are looking toward CROs to innovate. This places stronger strategic demands on PMs to further expand their technical and soft skills, but also impacts CROs to provide additional support to ensure project success.
Volker Hack is senior director and head of the project management standards group. Denise Sackner is director of early development services standards.