Global Study Start Up Lead

Parexel International; United Kingdom; Remote; GBP 60,000 - 80,000; Full time

Job summary

A global clinical research organization is seeking an experienced Global Start Up Lead/Manager to develop and execute study start-up strategies across various therapeutic areas. Candidates should have significant experience in global trials, with at least 8 years in start-up roles and adeptness with clinical study management software. The role involves leading start-up meetings, overseeing site activation, and ensuring efficient processes across regions. Candidates must also exhibit strong critical thinking and risk management skills.

Qualifications

• Minimum 8 years of relevant global trial SSU experience.
• Exposure across North America, Asia and Europe.
• Concurrent management of complex processes across countries.

Responsibilities

• Define and deliver the global study start up project strategy.
• Lead start up meetings for site activation.
• Manage activities for site activation for assigned studies.

Skills

Global start up experience

Technical expertise in clinical study management software

Risk management techniques

Critical thinking

Good communication across diverse audience

Education

Bachelor's degree

Tools

Project management software

Reporting systems

Job description

Parexel is beginning to search for an experienced global Start Up Lead/Manager to join one of our key sponsors in the EMEA.

In this role you are accountable and responsible for defining, developing and delivering the global study start up project strategy by partnering with roles across the wider study teams as required. The SSU Lead will be assigned to one or more interventional studies in one or more therapy areas such as oncology, vaccines, internal medicine, rare disease or inflammation and immunology. You will take full responsibility for studies covering at least three regions.

Some specifics about this advertised role

• Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint.

• Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study.

• Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan.

• Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the system which build the overall targets for site activation over time in alignment with the priority of the study in the overall portfolio and overall expectation to deliver to plan with a high degree of probability.

• In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies.

• Act as a key point of escalations for site activation related issues raised by country level start up roles, seeking to firstly resolve issues directly or triage appropriately to other SUPMs on the study or the study management team, will always follow through to resolution.

• Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role

• Bachelor’s degree and minimum 8 years of relevant global trial SSU experience.

• Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas

• Concurrent management of complex processes within and across countries in multiple regions of the world

• Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)

• Expert ability to comprehend status and adapt communications across a diverse audience

• Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles

• Will use generative artificial intelligence techniques in daily work

• Uses risk management techniques as standard to identify and mitigate key project delivery risks

• Critical thinker with strategic planning, analytical and problem-solving skills that responds positively to rapid change