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&#**Apply on the website**;s ERB and Competent Authority
(CA)(where applicable), communicate and negotiate budgets with site
personnel and internal teams, negotiate and obtain fully-executed
contract, 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 procurement, 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
Basic Qualifications
* Bachelor&#**Apply on the website**;s degree preferably in a
scientific or health related field, two years clinical research
experience or relevant experience preferred
* Understanding of the overall clinical development paradigm and the
importance of efficient site initiation
* Applied knowledge of project management processes and skills
* Appreciation of / experience in compliance-driven environment
* Ability to learn and comply with financial and legal guidelines and
policies (budget and contract)
Additional Skills/Preferences
* Effective communication, negotiation, and problem solving skills
* Self-management and organizational skills
* Fluent in English and French/German/Spanish/Italian other EU
language
**Apply on the website**k-**Apply on the website**k + 5% bonus This Role is Located in Cork, Ireland***
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&#**Apply on the website**;s ERB and Competent Authority
(CA)(where applicable), communicate and negotiate budgets with site
personnel and internal teams, negotiate and obtain fully-executed
contract, 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 procurement, 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
Basic Qualifications
* Bachelor&#**Apply on the website**;s degree preferably in a
scientific or health related field, two years clinical research
experience or relevant experience preferred
* Understanding of the overall clinical development paradigm and the
importance of efficient site initiation
* Applied knowledge of project management processes and skills
* Appreciation of / experience in compliance-driven environment
* Ability to learn and comply with financial and legal guidelines and
policies (budget and contract)
Additional Skills/Preferences
* Effective communication, negotiation, and problem solving skills
* Self-management and organizational skills
* Fluent in English and French/German/Spanish/Italian other EU
language
**Apply on the website**k-**Apply on the website**k + 5% bonus
We need : English (Good)
Type: Permanent
Payment:
Category: Others
