Study Start Up Lead

Description du poste:

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

As a member of the PDG Country Study Start Up Team in Denmark, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start up needs across various therapeutic areas, and ensure a seamless process. Collaboration with local country teams, global study teams, and CROs is essential to this role.

The Opportunity

This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by executing effective start-up strategies while maintaining regulatory compliance. Additionally, this role involves managing amendments throughout the study lifecycle.

Study Start Up Strategy & Execution:
Support and execute study start-up strategies for faster site activations, collaborating with internal and external teams, CROs, and sites. Help identify issues, follow regulations/SOPs, and assist with Health Authority/Ethics Committee communication. Track submissions in relevant systems and stay updated on regulatory requirements.

Informed Consent Form (ICF) Management:
Assist in preparing/adapting ICFs, supporting IRB/EC/HA submissions and changes, and archiving approvals.

Site Documentation & Compliance:
Collect and verify site documents (CVs, etc.). Assist with translations, patient materials, and biobank details. Learn local document needs and timelines. Support local vendors (excluding CROs) if needed.

Budgeting & Contract Management:
Provide assistance with contract negotiations & execution (confidentiality, indemnity, amendments). Collaborate with internal/external partners on financial/legal compliance. Help update contract system data for planning.

Payment Oversight:
Assist in overseeing site payments, escalations, and reporting via shared service centers and in compliance with site contracts. Help ensure financial/regulatory compliance for local operations. Participate in accrual/purchase order planning and reconciliation.

Administrative tasks:
Oversee various administrative tasks that ensure that PDG Denmark is running smoothly

Who You Are
* You hold a degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent.
* You bring demonstrated experience in clinical trial start-up and cross-functional collaboration, along with a strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
* You excel in communication and interpersonal interactions and show strong organizational, analytical, and problem-solving capabilities.
* You are proficient in clinical systems (Veeva Vault, CTIS, RIM, etc.).
* You demonstrate a collaborative and adaptable mindset with strong attention to detail.
* You possess fluency in written and spoken English and Danish.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer