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The Position

Purpose Objectives and Scope of Position
As a member of the PDG Country Study Start Up Team 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 seamless trial execution for patients investigators and clinical site staff. Collaboration with local country teams global study teams and CROs is essential to this role.

Key Responsibilities
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. You will bring subject matter expertise and may work cross functionally in the following areas below:

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.

Clinical Trial Submissions & Regulatory Coordination:
Prepare and manage submission packages for regulatory bodies and health authorities. Assist in responding to RFIs and ensure timely document submission to the TMF. Support study amendments and notifications.

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.

Qualifications
Degree (MD PhD MA/MS BA/BS) in life sciences or equivalent. Postgraduate degree or masters degree highly desirable

Skills and Competencies

Fluency in written and spoken English is mandatory.

Fluency in written and spoken language(s) of the host country is mandatory.

IMPACT LEVELS

Acquires basic knowledge to assist with study start-up in clinical trials and drug development including learning about the clinical trial industry and how trials work. Completes tasks following standard procedures and guidance.
Gains practical skills in clinical trial study start-up by assisting with the execution of country clinical trial start-up activities.
Assists with process improvements and changes by completing assigned tasks. Offers basic input based on observations.

Follows directions for clinical trial study start-up projects. Can organize simple tasks.

Works with other groups within PDG to complete assigned tasks in delivering projects.

Learns about and follows ICH GCP and regulatory guidelines for clinical trials.

Becomes familiar with other departments and sees how their teams work affects other parts of the business.

Assists administratively in working with selected vendors to support clinical trials and/or enabling projects.

QUALIFICATION LEVELS
Has theoretical knowledge within a job discipline typically gathered through a professional qualification equivalent working experience or higher level education (e.g. undergraduate). Performs assignments within existing procedures and instructions.
Works on assigned problem areas. Follows provided steps and instructions to resolve issues. May need assistance to determine next steps or who to contact.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.