Regional Study Start Up Lead

Biogen; Maidenhead; Ibrido; GBP 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Biogen is seeking a Regional Study Start-Up Lead to drive site activation across European countries, with expert EUCTR knowledge and hands-on start-up experience. This role requires coordinating SSU specialists and ensuring timely, quality site activations across the region, including overseeing regulatory and EC submission processes.

You will lead cross-functional teams, manage timelines, and communicate activation strategies to country teams while maintaining alignment with business goals.

Competenze

• Bachelor's Degree in life sciences or equivalent (e.g., pharmacy, nursing).
• Clinical trial experience, with solid experience in a study start-up role and at a regional level.
• Have worked in a study start-up group with ICF review, regulatory document review, and submission experience for the European region.
• Previous experience in a CRO is essential.
• Strong EUCTR experience – previously involved in submissions.
• Proven experience in project management and site activation.
• Excellent communication, organizational, and leadership skills.
• Proactive mindset with ability to identify bottlenecks and propose solutions.
• Ability to manage multiple projects, coordinate cross-functional teams, and work in a matrix environment.
• Excellent English communication (listening, oral, written).
• Comfortable using CTMS, eTMF, Veeva, and Microsoft Project.

Mansioni

• Lead day-to-day management of multiple projects or a multi-study program for site activation.
• Drive site selection processes within your region to ensure timely and efficient activation.
• Oversee site activation according to timelines and quality standards across a region.
• Communicate site activation strategy to country teams and monitor progress.
• Act as a SME in EUCTR ensuring timely collection of part 2 documents for all countries and sites you oversee.
• Ensure ECs and Regulatory authorities have been paid in a timely manner.
• Coordinate SSU specialists across regions and ensure sites stay on the critical path.
• Escalate issues identified by SSU specialists including regulatory and vendor setup issues.
• Monitor project status, identify risks, and provide metrics to Study Start-up Oversight Lead.
• Ensure Oversight Lead is aware of risks and develop mitigations.
• Facilitate knowledge transfers across countries within regions.
• Collaborate with Regional/Oversight Leads to resolve issues and ensure adherence to plan.
• Oversee EC submission strategy and required documents: patient facing materials (ICFs, questionnaires).
• Manage country and site ICF timelines; review and approve country ICFs.
• Provide quality checks for EC submission packages and essential documents.
• Ensure operational readiness for site activation with CML, site binders, lab kits, training, and system access.
• Coordinate information flow among stakeholders and sign-off on site activation forms.
• Ensure consistency and application of processes within studies.
• Initiate and execute study-related progress reports.
• Provide oversight of amendment implementations as needed.

Conoscenze

Bachelor's Degree in life sciences

Clinical trial experience

ICF review experience

Regulatory document review experience

Submission experience

CRO experience

EUCTR experience

Project management

Site activation

English communication

CTMS

eTMF

Veeva

Microsoft Project

Formazione

Bachelor's Degree in life sciences or equivalent

Strumenti

CTMS

eTMF

Veeva

Microsoft Project

Descrizione del lavoro

About This Role

As a Regional Study Start-Up Lead, you will play a pivotal role in managing the effective delivery of site activation for European countries. For this particular role you will be required to have expert knowledge in EUCTR and hands on study start up experience within the European region. This position is crucial in overseeing site activation according to prescribed timelines and quality standards, while coordinating closely with SSU Specialists. You will be responsible for managing technical and operational aspects to ensure successful site selection and activation. Your leadership will be instrumental in driving site selection efforts, communicating strategies to country teams, and monitoring progress to maintain alignment with business goals. By spearheading these initiatives, you contribute significantly to our overarching mission of delivering high-quality clinical trials and advancing healthcare solutions. It is required to work in the Baar, Switzerland office 3 days a week.

What You'll Do

• Lead day-to-day management of multiple projects or a multi-study program for site activation.
• Drive site selection processes within your region to ensure timely and efficient activation.
• Oversee site activation according to timelines and quality standards across a region.
• Communicate site activation strategy to country teams and monitor progress.
• Act as a SME in EUCTR ensuring timely collection of part 2 documents for all countries and sites that you are overseeing.
• Ensure that all ECs and Regulatory authorities have been paid in an appropriate timeframe.
• Coordinate SSU specialists across regions and ensure all sites within regions are on track with the critical path site activation plan.
• Serve as an escalation point for issues identified by SSU specialists, including regulatory and vendor setup issues.
• Monitor project status, identify risks, and provide metrics to the Study Start-up Oversight Lead.
• Ensure that Oversight Lead is aware of any risks to study timelines and develop appropriate mitigations.
• Facilitate knowledge transfers across countries within regions.
• Collaborate with other Regional/Oversight Leads to resolve issues and ensure activation activities adhere to the agreed plan.
• Oversee EC submission strategy and required documents: patient facing materials: ICFs, questionnaires, etc.
• Manage country and site Informed Consent Form (ICF) timelines; review and approve country ICFs.
• Provide quality checks for EC submission packages for both central and local ECs.
• Provide quality checks of essential documents and essential document packages.
• Ensure operational readiness for site activation in collaboration with CML, including site binders, ancillary supplies, lab kits, training, and system access.
• Coordinate information flow between key stakeholders involved in site activation and ensure that the site activation form is signed off in a timely manner.
• Ensure consistency and application of processes within studies.
• Initiate and execute study-related progress reports.
• Provide oversight and management of amendment implementation as needed.

Who You Are

You thrive in dynamic environments, demonstrating an ability to manage multiple projects and coordinate cross-functional teams with ease. Your strong communication and leadership skills enable you to effectively influence stakeholders and drive results. You possess a proactive mindset, always looking to identify bottlenecks and propose innovative solutions. Your experience working in study start-up roles at a regional level on clinical trials equips you with the expertise needed to navigate complex challenges. You are detail-oriented and adept at handling a high volume of tasks, ensuring that priorities are met in a timely manner.

Required Skills

• Bachelor's Degree in life sciences or equivalent (e.g., pharmacy, nursing).
• Clinical trial experience, with solid experience in a study start-up role and at a regional level.
• Haved worked in a study start-up group and have experience (specifically, ICF review experience, regulatory document review experience, and submission experience) managing startup for the European region.
• Previous experience in a Contract Research Organization (CRO) is essential.
• Strong EUCTR experience – previously involved in submissions.
• Proven experience in project management and site activation.
• Strong communication, organizational, and leadership skills.
• Proactive mindset with the ability to identify bottlenecks and propose solutions.
• Ability to manage multiple projects, coordinate cross-functional teams, and work in a matrix environment.
• Proven ability to handle a high volume of tasks of varying complexity and effectively utilize escalation pathways.
• Excellent communication skills (listening, oral, written) in English.
• Comfortable using CTMS, eTMF, Veeva, and Microsoft Project.

Preferred Skills

• Familiarity with regional regulatory processes and requirements.
• Experience in leading cross-functional teams effectively.
• Advanced proficiency in clinical trial management trackers and tools.

Job Level: Management

Why Biogen

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.