Study Start-Up Specialist (SSUS)
شارك هذه الوظيفة
موقع الوظيفة:
الراتب شهرياً:
تاريخ النشر:
نُشرت قبل 13 يوم
عدد الوظائف الشاغرة:
1 عدد الوظائف الشاغرة
ملخص الوظيفة
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
The Study Start-Up Specialist (SSUS) plans and develops strategy for start-up activities prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents to ensure successful recruitment and delivery of trial milestones.
Your Responsibilities
Collaborates with Clinical Study Leader and sites to ensure timely delivery of start-up milestones and supports site feasibility assessments.
Ensures inspection readiness of study and site documentation while maintaining compliance with local regulatory requirements.
Builds efficient collaborations with site staff ensuring physicians are trained and prepared for studies.
Develops and updates training documentation conducting training as necessary.
Negotiates site contracts/budgets ensuring adherence to Fair Market Value (FMV).
Evaluates site practices for quality and integrity escalating issues to the Clinical Study Leader as needed.
Manages site performance by tracking start-up milestones and providing logistical support for clinical trial supplies.
Who you are
Demonstrated strong leadership by successfully leading multi-functional study teams through all stages of clinical studies.
Proven strategic and organizational skills with a proactive approach to planning risk management and contingency embedding.
In-depth understanding of ICH/GCP regulations and quality requirements with effective communication skills for clear instructions and team motivation.
Excellent problem-solving negotiation and conflict resolution abilities fostering collaboration and stakeholder management across teams.
Committed to creating a psychologically safe environment that empowers individuals and aligns with Roches values and leadership principles.
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.
Required Experience:
IC
المهارات المطلوبة
- Sales Experience
- الرافعة/الونش
- خدمة العملاء
- مهارات التواصل
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
عن الشركة
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
