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Senior Clinical Data Analyst - based in UK, Romania, Poland, Hungary

85% Flex

EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE - FULLY FLEXIBLE

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

Romania, United Kingdom

Offer summary

Qualifications:

Bachelor’s degree, Fluent English, Experience in clinical research.

Key responsabilities:

Perform data cleaning activities
Manage project timelines and review protocols
Support data processing from setup to lock

Parexel Pharmaceuticals XLarge https://www.parexel.com/

10001 Employees

See more Parexel offers

Job description

Your missions

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

What you will do:

The Senior Clinical Data Analyst (SCDA) shall independently perform all clinical data cleaning activities on assigned FSP projects, commensurate with experience and/or project role. Further responsibilities shall include support on data processing activities and study level documents e.g., Protocol Deviation Specification, Data Validation specification, etc.

The SCDA may act as a Data Management Lead where required.

Key Accountabilities:

Lead/Responsible for data cleaning and data review activities e.g., query management.
Management of project timelines (including creation, review and tracking of plans).
Review of protocols and EDC Screens if required.
Support data processing activities from database setup to database lock, e.g., SAE reconciliation.
Perform user acceptance testing on study database setups.
Perform medical coding on small studies.
Track and review CRFs. Support data entry where required.
Perform and or support the setup of DM documents and ensure proper documentation e.g., CRF Completion Guidelines (CCG)
Perform/lead functional QC activities and testing.
Mentor project team members.
Be a subject matter expert when needed.

Ideal candidate will possess:

Bachelor’s degree as a minimum.
Fluent English.
Proven experience in clinical research (CRO/Pharma).
Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.
Sound awareness of relevant regulations, including ICH-GCP, 21CRF11.
Excellent interpersonal, verbal and written communication skills.
Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG).
Good knowledge of EDC systems (e.g., DataLabs, Rave.)
Good knowledge of electronic source data capture systems (e.g. ClinBase).
Good knowledge of all DB set-up activities including but not limited to Database Configuration. Specifications, Data Validation.
Ability to work in team environment.
Good analytical skills and attention to detail.
Basic knowledge of SAS.