Trial Activation Contract Specialist I FSP
Thermo Fisher ScientificSalary not specified
Full Time
Junior (1 to 2 years)
Clinical Trial Start Up Associate, Romanian at Eli Lilly and Company
Cork, County Cork, Ireland
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, HealthcareIndustries
Requirements
- Bachelor’s degree
Responsibilities
- Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA) (where applicable), track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
- Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
- Identify, communicate, and resolve issues
- Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Leverage previous site / review board engagements to efficiently drive new work
- Populate internal systems to ensure accuracy of trial / site performance
- Understand and comply with procurements, legal and financial requirements and procedures
- Populate Trial Master Files and libraries for future reference
- Provide feedback and shared learning for continuous improvement
- Leverage trial prioritization
- Anticipate and monitor dynamically changing priorities
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What benefits does Eli Lilly Cork offer?
Eli Lilly Cork offers flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, on-site parking, inhouse People Development services, Educational Assistance, and ‘Live Your BEST Life’ wellbeing initiatives.
Is this a remote or hybrid role?
The role offers flexible hybrid working options from the campus in Little Island.
What are the main responsibilities of this role?
The role involves initiating investigator site activities like collecting and submitting regulatory documents, customizing and negotiating informed consent documents, obtaining clinical trial authorizations and ethical approvals, records management, site training, and ensuring inspection readiness through a complete Trial Master File.
What is the company culture like at Eli Lilly Cork?
Eli Lilly Cork features a talented diverse team of over 2000 employees across 60 nationalities, with a strong commitment to diversity, equity, and inclusion through pillars like EnAble, embRACE, LGBTQ+ & Ally, and GIN-Gender Inclusion Network, encouraging employees to Be Creative, Be an Innovator, and Be Yourself.
What salary can I expect for this position?
This information is not specified in the job description.
Eli Lilly and Company
Develops and delivers prescription medicines globally
About Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.
Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees