Project Management

At ClinOps Specialists, we offer project management not just for clinical studies but for any project.

We have experience in managing a wide range of projects for the pharmaceutical industry, including entire drug development programs, regulatory submissions and agency interactions, study drug formulation and manufacture, and medical writing.

An excellent Project Manager is an invaluable part of any project team. They are the first point of contact for any issues, develop relationships with all stakeholders, resolve conflicts. They also ensure that project delivery is smooth, on time and within budget, freeing up the rest of the team to focus on their assigned tasks.

Project Manager Graphic
Project Management – the central focus for project success

Project Planning

At ClinOps Specialists, we bring deep experience with a wide range of project management tools to support smooth project delivery. We maintain clear action and decision logs to keep projects on track and ensure key discussions are documented.

Using tools like Microsoft Planner (formerly MS Project), we develop both high-level and detailed project plans tailored to your needs.

We conduct regular progress reviews, adjusting timelines and priorities as needed to keep momentum and deliver results.

Proper Planning Prevents Poor Performance

PRINCE2 is a project management methodology that is mostly used in the UK, Australia and European countries. “PRINCE2” stands for Projects IN Controlled Environments, because this method focuses on managing resources and risks by dividing projects into smaller stages, defining clear roles & responsibilities and using seven processes to manage the project life cycle.

By organising the project into logical steps, PRINCE2 demands a project management framework that has an organised and controlled project plan before starting, one that maintains its organisation through the project life cycle.

PRINCE2 uses the 7 themes of business case, organisation, quality, plans, risk, change and progress to manage the project from start to finish.

PRINCE2® is one of the most widely adopted project management methodologies in the world, and with good reason. Since its introduction in 1996, it has proven its value across industries by providing a clear, structured and scalable approach to managing projects of all sizes. 

At ClinOps Specialists, we incorporate PRINCE2 principles where appropriate to support governance, risk management and consistent delivery.

Agile® is a methodology and mindset used primarily in project management and software development that emphasises iterative progress, collaboration and flexibility. Here are some key points about Agile:

  • Definition: Agile is a set of methods and practices where solutions evolve through collaboration between self-organizing, cross-functional teams.
  • Framework: It breaks projects down into several dynamic phases, commonly known as sprints, allowing for adaptive planning and rapid execution.
  • Principles: Agile project management reflects the values and principles agreed upon by The Agile Alliance, focusing on continuous delivery and improvement.
  • Benefits: Agile enables teams to deliver value faster and with fewer headaches by working in small, consumable increments.

For fast-moving or evolving projects, Agile project management offers the flexibility and responsiveness needed to stay ahead. At ClinOps Specialists, we adapt Agile principles to support iterative planning, continuous stakeholder engagement and rapid course correction.

The Agile approach is ideal for dynamic environments where requirements evolve and speed is essential.

At ClinOps Specialists, we use Gantt charts as a core part of our project management toolkit to plan, schedule and track progress effectively. Gantt charts provide a clear visual representation of project timelines, task dependencies and milestones, helping both our team and our Clients stay aligned from start to finish.

By mapping out all activities in one place, we improve planning accuracy, task delegation, resource allocation, and remote collaboration. They also allow the Project Manager to assess the impact of task delays on other project activities and determine those tasks that have the most impact on the project timelines (the critical path). This visibility empowers project teams to stay focused, adapt quickly and deliver projects on time and within scope.

Gantt charts show inter-task dependencies and allow monitoring of the project’s critical path.

Example project plan for a Type C Meeting request with the FDA

Risk and Issue Management

Proactive risk management is central to successful project delivery at ClinOps Specialists. We conduct risk identification and assessment to surface potential challenges soon after project initiation. This allows us to acknowledge and mitigate risks proactively, reducing their impact on timelines, quality and outcomes.

When unexpected issues arise, whether from unforeseen risks or gaps in mitigation, our Project Management team responds swiftly, collaborating with stakeholders to identify solutions and keep the project moving forward.

Every project has risks – it’s much better to tackle them before things get out of hand.

Whether you’re preparing for an internal meeting, a Board presentation, or an investor pitch, ClinOps Specialists can transform complex project details into clear, high-impact and easy to digest visuals.

We create concise, schematic slides that communicate key information at a glance, helping you engage stakeholders, align teams, and drive decisions with confidence.

High-level schematics get your message across fast, so you can inform, impress and drive action.

Example Project Schematic
Example high level Project schematic

Kanban is a fast, flexible Agile project management tool that boosts visibility, streamlines workflow and keeps teams moving.

Kanban breaks down projects into clear steps and empowers team members to pick up tasks based on priority and capacity, perfect for lean teams juggling multiple priorities.

At ClinOps Specialists, we use Kanban to manage tasks like Investigator Brochure updates, grouping work into columns such as “Up Next”, “In Progress”, and “Completed”. Tasks are flagged and assigned, and as one finishes, the next moves forward, keeping momentum high and bottlenecks low.

Kanban is a great solution for the management of rapidly evolving projects with multiple priorities.

Kanban example
Example Kanban board