eTMF Specialist

Position summary

Key stakeholder concerning further optimization of eTMF structure and processes in close cooperation with cross-functional teams, IT department and external vendors to improve user-friendliness.

Performs detailed eTMF quality checks/reviews with follow-up for missing documentation in collaboration with Clinical Project Manager and Clinical Project Assistance across the Sotio clinical development programs.

Ensures eTMF inspection readiness at any time.

Key Activities and Responsibilities

Responsible for initial set-up and maintenance of the eTMF structure
Responsible to monitor vendor (CRO) eTMF performance to ensure sponsor oversight
Participates in eTMF Veeva Vault regular updates evaluation and implementation together with IT department
Plans and conducts system trainings for internal and external users and provides process guidance as required

Competences, Skills and Qualification

Bachelor degree in a science-related field
2 years of eTMF management experience at a biotechnology, pharmaceutical company or Clinical Research Organization
Solid experience with eTMF system software - Veeva Vault knowledge is preferred
Sound knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
Strong clinical, technical and ideally oncology disease area expertise
Excellent communication, interpersonal and organizational skills
Fluent English communication and writing skills
Attention to detail and timelines

Location

Jankovcova 1518/2, 170 00 Praha 7, Česká republika

Mám zájem Apply

Cookie name	Description	Expiration
BCAPPSESSID3	The BCAPPSESSID3 cookie is native to PHP and enables websites to store serialised state data. It is used to establish a user session and to pass state data via a temporary cookie, which is commonly referred to as a session cookie.	14 days
SSC_COOKIE_*	This cookie stores your decision regarding the storage of cookies in your browser.	2 years

Cookie name	Description	Expiration
_ga	The GA cookie is set, when a person visits your website for the first time. Google Analytics sends the client ID with each hit in order to associate hits with a user. A GA cookie can exist only on the device and browser where it has been set.	2 years
_gid	This cookie is installed by Google Analytics. The cookie is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing.	24 hours
_gat_gtag_UA_27872723_1	This cookie is used to throttle request rate. These are third party cookies that are placed on your device to allow us to use the Google Analytics service. These cookies are used to collect information about how visitors use our website. We use this information to compile reports and to help us improve the website.	Immediately
AW_VISITOR	Performance cookie to analyze traffic.	1 year

eTMF Specialist

Position summary

Key Activities and Responsibilities

Competences, Skills and Qualification

Location

Your privacy

Strictly necessary cookies

Performance cookies

Functional cookies

Targeting and Advertising cookies

More information about Cookies