At a Glance
- Tasks: Lead global study start-up projects and activate investigative sites for clinical trials.
- Company: Join a leading global clinical research organisation with a focus on innovation.
- Benefits: Attractive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic work environment with a strong emphasis on teamwork and collaboration.
- Why this job: Make a real difference in healthcare by managing impactful clinical studies.
- Qualifications: Experience in clinical research and project management is essential.
The predicted salary is between 60000 - 80000 € per year.
The Start Up Project Manager (SUPM) is responsible for defining, developing and delivering the global study start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required. The SUPM will be assigned to one or more interventional studies in therapy areas such as oncology, vaccines, internal medicine, rare disease or inflammation and immunology.
The responsibility of the SUPM typically ends when all investigative sites are activated and ready to enroll participants, however this can extend further into the participant recruitment period to specifically deliver the implementation of protocol amendments across active sites for selected studies. The SUPM will have a comprehensive knowledge of managing and coordinating study start up activities globally.
The SUPM II will typically take full responsibility for medium to large size studies across all regions and countries, or for selected countries or region(s) of a global study where another SUPM is responsible for the site activations of the entire study. The SUPM II is the leader of the start up sub team for the study, region(s) or countries assigned.
Accountability
- Reports to Director/Sr Director of Start Up Project Management or Start Up Project Management Group Lead.
- Acts as an ad-hoc member of the core study team throughout the start up phase of a study.
- Partners 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.
- Responsible for delivering site activations to plan, particularly for studies with higher operational complexity.
- Coordinates with various roles working at the study and country level to oversee progress of study specific or country specific tasks that need to be completed for site activations.
- Leads start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles.
- Works with country level start up roles to seek opportunities to accelerate site activations for their study.
Plan Delivery
- Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system.
- Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system.
- Ensures consistent participant compensation for sites and institutions taking part in multiple studies concurrently.
- Leads the continual assessment of current and future workload to proactively anticipate, problem solve and request appropriate changes.
- Integrates the requirements of protocol amendments to deliver site activations to plan.
- Responsible for the completeness and quality of site activation timeline plans for every site.
- Plans and executes the timely delivery of the investigator initiation package needed for investigational product release to site.
- Coordinates across all roles that work directly with site staff to complete site activation readiness tasks.
- Establishes and executes communication plans across major teams involved in start up.
Risk Mitigation
- Coordinates across the study team and extended partners to deliver site activations to plan.
- Assesses the ongoing site activation readiness status and proactively identifies and mitigates risks.
- Acts as a key point of escalations for site activation related issues raised by country level start up roles.
- Seeks to remedy performance concerns with internal and external teams sensitively but promptly.
Skills
- Demonstrated clinical research experience.
- Demonstrated start up experience.
- Demonstrated project management experience.
- Global start up experience across multiple therapeutic areas.
- Technical expertise in the use of software for the management of clinical studies.
- Expert ability to comprehend status and adapt communications across a diverse audience.
- Critical thinker with strategic planning, analytical and problem-solving skills.
Knowledge And Experience
- Extensive global start up clinical trial/study management experience.
- Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations.
- Fluency in English is required.
Education
- Scientific or technical degree is preferred.
- BS/BA – 7 years relevant experience.
- MS/PhD – 5 years relevant experience.
Start Up Project Manager II - FSP in Uxbridge employer: Parexel
As a Start Up Project Manager II at our company, you will thrive in a dynamic and collaborative work environment that prioritises innovation and professional growth. We offer competitive benefits, including comprehensive health plans and opportunities for continuous learning, all while working on impactful global studies in cutting-edge therapy areas. Join us in our commitment to excellence and make a meaningful difference in the world of clinical research.
StudySmarter Expert Advice🤫
We think this is how you could land Start Up Project Manager II - FSP in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. Understand their projects and challenges, especially in areas like oncology or rare diseases, so you can show how you can contribute right from the start.
✨Tip Number 3
Practice your pitch! Be ready to explain your experience in managing complex studies and how you've tackled challenges in the past. Confidence is key, so rehearse with friends or in front of a mirror.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team.
We think you need these skills to ace Start Up Project Manager II - FSP in Uxbridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the SUPM role. Highlight your project management experience and any global start-up knowledge you have. We want to see how you can bring value to our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your background aligns with our mission at StudySmarter. Keep it engaging and personal, we love a good story!
Showcase Your Skills:Don’t just list your skills; demonstrate them! Use specific examples from your past experiences that show how you've successfully managed complex projects or navigated challenges in start-up processes. We’re looking for problem solvers!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining the StudySmarter family!
How to prepare for a job interview at Parexel
✨Know Your Stuff
Make sure you have a solid understanding of the clinical research landscape, especially in global start-up processes. Brush up on your knowledge of Good Clinical Practices and the specific therapeutic areas mentioned in the job description, like oncology and vaccines.
✨Show Your Project Management Skills
Be ready to discuss your project management experience in detail. Prepare examples of how you've successfully managed complex processes across multiple regions. Highlight any tools or software you've used for managing clinical studies, as this will show you're tech-savvy and ready for the role.
✨Demonstrate Team Collaboration
Since the role involves working with various teams, be prepared to talk about your experience in cross-functional collaboration. Share specific instances where you coordinated with different roles to achieve a common goal, especially in high-pressure situations.
✨Prepare for Problem-Solving Questions
Expect questions that assess your critical thinking and problem-solving skills. Think of scenarios where you've had to identify risks and implement solutions in a project. Use the STAR method (Situation, Task, Action, Result) to structure your answers effectively.
