This New Year, Don’t Hope for Change… Manage It!
by Meghan O'Brien (Zuchlewski), Operations & Change Lead, Just in Time GCP
Each January, we start fresh with new goals, new priorities, and new plans. We promise ourselves that this year will be different.
But by February, nearly 80% of resolutions have faded.
Not because people don’t want to change, but because wanting isn’t managing.
Change, whether personal or professional, requires more than motivation. It requires structure, support, and sustainability.
In clinical research, it is no different. Every year brings new systems, revised SOPs, and evolving regulatory expectations such as ICH E6(R3). Yet even the best-intentioned initiatives can stall when the excitement of kickoff fades and the reality of adoption sets in.
That’s why effective change management in clinical research is no longer optional; it’s essential. And it’s where Just in Time GCP’s three-stage Change Management framework to Prepare, Manage, and Sustain, turns good intentions into measurable, lasting results.
Prepare: Define the Change (Resolution)
Most resolutions and clinical change initiatives fail because they are too vague.
“Get in shape” sounds great, but it’s not actionable. Neither is “Improve TMF quality.”
In the Prepare phase, sponsors define the change clearly and specifically:
- What’s changing and why now?
- Who’s impacted and how?
- What does success look like and how will it be measured?
The same logic applies to personal goals. Replace “Read more” with “Finish one new book each month.” Specificity brings clarity, and clarity builds commitment.
When teams take the time to define scope, vision, and measurable success criteria upfront, they build the foundation for alignment, and ultimately, for adoption.
Manage: Enable and Engage (Build Momentum)
Change feels easy on day one. It’s day 21 — or day 75 — that tests your resolve.
That’s why Just in Time GCP’s Manage phase focuses on enablement and engagement, two elements that sustain momentum.
Enablement ensures teams have the training, tools, and time to succeed.
Engagement keeps the “why” alive, connecting people to the purpose behind the change.
In clinical operations, this means:
- Delivering clear, role-based training and communication.
- Creating feedback loops to surface pain points early.
- Recognizing milestones and reinforcing positive behaviors.
In life, it might mean blocking time on your calendar, tracking progress, and celebrating wins along the way.
Because whether it’s a new eTMF workflow or a new fitness routine, momentum comes from manageable milestones.
Sustain: Reinforce the Change (Make It Stick)
Starting change is one thing. Sustaining it is what defines success.
In the Sustain phase, Just in Time GCP helps sponsors embed change into daily operations through metrics, check-ins, and reinforcement; ensuring that new habits become business as usual.
- Review progress regularly and celebrate small wins.
- Reflect on what is working and what needs refinement.
- Reinforce behaviors until they become second nature.
The same principle that keeps a TMF inspection-ready can keep a New Year’s resolution on track: sustainment and consistency built through reflection and recognition.
Turning Intentions into Outcomes
Change management in clinical research isn’t just about following steps; it is about creating the conditions where people can thrive amid transformation.
When managed poorly, change leads to confusion, resistance, and rework. When managed well, it improves compliance, strengthens collaboration, and protects timelines, both in trials and in teams.
Resolutions fail for the same reason initiatives do, because we stop managing them once they begin.
So, this year, instead of hoping for change, manage it.
Prepare with intention.
Manage with structure.
Sustain with reinforcement.
Because whether you’re improving yourself or your study, lasting change doesn’t happen by chance, it happens by design.
Authored by Meghan O'Brien (fka Meghan Zuchlewski), Operations & Change Lead, Just in Time GCP
With nearly four years at Just in Time GCP, Meghan leads our Change Management service offering. She built our standardized change management methodology from the ground up, creating a suite of 20+ tools that help trial sponsors implement change effectively and with confidence.
