Clinical Data Manager
Are you a Clinical Data Manager interested in a new challenge with an award-winning, global CRO?
Clintec is a business built around people who strive for excellence, and we currently have an exciting opportunity available for an experienced Clinical Data Manager to join our team in Spain. The role will be sponsor office based in Barcelona.
As a Clinical Data Manager you will be responsible for the day-to-day operational data cleaning activities and general administrative tasks involved in clinical trials including trial start-up, conduct, and close-out activities.
Collaboration in the selection of the Contract Research Organizations (CROs).
Coordination of the calendar and processes of clinical data management activities of the clinical trials with the rest of roles of the sponsor Clinical Study Team.
Review of the protocol for adherence of clinical data management good practices and CDISC standards.
Lead the review and approval of the annotated documents and study metadata for adherence to applicable CDISC standards.
Coordination and oversight of clinical data management - overall supervision and main contact with CRO along the study phases:
Set-up: CRF design approval, review of annotated documents, study metadata, SDTMs specifications, Data Management Plans (including coding, validation plan, etc.) vendor’s databases and data transfers specifications
Study Conduct: Manage CRO to have data transfers available on time for sponsor data review and visualization. Assessment of the data structure and study documentation review, evaluation of the data quality in on-going basis. Follow-up data findings resolution with CRO.
Closure: Management of the database lock processes, review related database lock documentation (including approval of coding and SAE reconciliation), evaluation of the database quality (minimum requirements) before database lock approval to guarantee sponsor requirements. Ensure final data and document transfers for long term storage.
At least two years as Clinical Data Lead or Data Manager in pharma industry or CRO.
CDISC expertise in CDASH and SDTMs data formats
Good English is essential
Strong communication skills with the ability to interact with internal and external stakeholder at various levels
WHY JOIN CLINTEC?
At Clintec, we understand that our people are our biggest asset and we value the hard work and dedication of all our employees.
By joining the Clintec team you can expect:
A competitive salary and benefits package including private healthcare and flexible benefits
25 days annual leave plus bank holidays
Real career development opportunities and a life-long career with an innovative, forward-thinking clinical research company
Click Apply Now to send your CV or email us directly on email@example.com for more information!
Clintec (an IQVIA company), established for 22 years, is an award-winning, full-service global clinical research organisation with our HQ office based in Scotland, UK. We support key product development and manage clinical trials in over 50 countries worldwide, across all major therapeutic areas, with expertise in Oncology and Rare Disease studies. We differ from other players in the clinical research industry as we combine the agility and flexibility typical of smaller CROs with the global coverage and management associated with large CROs.
Find out more by visiting www.clintec.com
Clinical Data Manager / Data Manager / Data Management / Data Programming / CDMS / Clinical Data Management System / EDC