PDG Clinical Operations Lead

Are you looking for a role that makes you feel valued, important and offers you the opportunity to make meaningful and transformative positive impacts on people's lives?

We are working with a global client whose ethos is plain and simple: we come to work to help be a part of a better future. If you are looking for a role within a business that inspires self-motivation, commitment and passion then you may just be the perfect missing piece to their team in Welwyn Garden City.

Our client requires a PDG Clinical Operations Lead. They are committed to rewarding their employees for their impactful challenging work, so here are the perks:

• Hybrid (2 days in office), providing flexibility when able
• Free parking onsite
• 25 days holiday per annum + recognised bank holidays

You will be the kind of person who wants to make a difference within your day-to-day work, but of course there are a few other requirements:

• Available for interviews at end of October 2024
• Possess strong working knowledge of the drug development process and respective regulations, including ICH and GCP guidelines.
• Have at least 3 years of relevant experience (clinical trial management is a plus).
• Hold a university degree or equivalent experience, ideally in life sciences.
• Maintain a high focus on quality service delivery for PDG throughout your assignment.
• Be a self-starter, driven by achieving successful outcomes and delivering results.
• Embrace a growth mindset.
• Adapt quickly, excel in fast-paced, ambiguous settings, and enjoy working collaboratively.
• Be talented, passionate, and aligned with our mission, thriving in our collaborative, dynamic, and entrepreneurial environment.

In this role you will be working in and amongst cross-functional global working group, or global Study Teams & COPECs, leading clinical trial operations, managing stakeholders, ensuring compliance, and driving efficient study delivery. You will also be responsible for:

• Leading or participating in cross-functional global working groups, COPECs, and global study teams to oversee all operational aspects of one or more studies through different phases and stages.
• Developing operational plans, managing clinical study budgets, and ensuring consistency in clinical operations.
• Managing risk and compliance by developing risk mitigation strategies, ensuring site monitoring, and adhering to ICH/GCP and other regulations.
• Leading feasibility assessments for country and site selection, guiding country operational representatives during trials.
• Overseeing resource management and forecasting to ensure clinical sites have the necessary supplies.
• Managing relationships with vendors and stakeholders, overseeing performance to ensure smooth study execution.
• Establishing leadership within the team, inspiring others to perform at their best, and shaping capabilities over time.
• Providing operational and strategic input to CODACs to support the delivery of clinical studies and programs.
• Contributing to COPECs by driving innovative solutions and ensuring efficient clinical trial delivery.
• Maintaining strong relationships with external stakeholders, including site-level engagement and healthcare partners, to support clinical trial success.
• Collaborating with internal and external stakeholders in global regions to support local business needs and ensure cohesive operations.

Requirements may change over time and candidates need to understand that this guidance is fluid.

Job Title: PDG Clinical Operations Lead

Location: Welwyn Garden City (Hybrid - 2 days in office)

Salary: 339.27 - 376.97 (PAYE) or 450.00 - 500.00 (UMB) per day

Full Time: 37.5 hours per week

6 Month Contract (Inside IR35)

For more information about this PDG Clinical Operations Lead role, please contact Chloe McCausland at Clearline Recruitment.