Job Description

Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
We are currently recruiting for a Study Start-up Leader who is accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to country regulations, Core/Site document collection/ approval, ICF customization/approval, EC and RA/ MoH submissions, SIV scheduling and activation requirements.
This role will be based remotely and can be based in a number of EMEA locations.

The Study Start Up Leader will manage the study start up process, through development of a site activation strategy and to oversee start-up delivery and governance.
Coordinate, develop and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, System Set-up, EDL Management, EC & RA/ MoH Strategy, ICF Customization, Risk Mitigations, Monitoring Plan, Site Activation Requirements & Relevant Tools.
Collaborate and communicate within the Global study team matrix to provide study start up strategy, input to milestone development, and alignment of operational targets to ensure timely delivery of study start up activities.


Qualifications


• Knowledge of applicable international regulatory requirements and guidelines (i.e. ICH-GCP, and/ or EU-Directives).
• Critical thinking and problem solving
• Strategic & tactical thinking skills
• Conflict management skills
• Consulting skills
• Strategic and creative risk management and contingency planning
• Ability to lead virtual teams across cultures and locations
• Excellent interpersonal, verbal, written and presentation skills
• Client-focused action-oriented approach to work
• Strong Leadership skills, with ability to influence both vertically and horizontally
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Able to work independently and manage assignments from a distance
• Sense of urgency and organization in completing tasks
• Strong understanding of cultural differences
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Proficient computer and internet skills, including working knowledge of MS-office applications, such as MS Outlook, Word and Excel
• Ability to travel, as required



Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.