Skip to main content

Clinical Data Specialist - Iqvia Biotech

Apply now
Primary Location: Tartu, Estonia Additonal Locations: Barcelona, Spain,ESP; Bratislava, Slovakia,SVK; Espoo, Finland,FIN; Istanbul, Turkey,TUR; Kaunas, Lithuania,LTU; Madrid, Spain,ESP; Oeiras, Portugal,PRT; Riga, Latvia,LVA; Sofia, Bulgaria,BGR; Stevenage, United Kingdom,GBR; Tallinn, Estonia,EST; Warsaw, Poland,POL Full time R1301906

Job description

Job Description Summary
IQVIA Biotech is a unique division specializing in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we are in is cutting edge for therapies with un-met medical need.

BASIC FUNCTIONS:
Clinical Data Specialist position is to ensure a complete and clean database per industry standards and client specifications

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Clinical Data and Query Review
- Issue queries and review query responses with the highest level of quality based upon the Data Review Plan, Manual Review (AE/CM compares, Inclusion/Exclusion review, etc.), Aggregate Checks (DM listings), and Reconciliation (LAB, SAE, ECG, and other vendors).
- Assist with other data reviews for Biostatistics, Medical Review, Sponsor, and other ad hoc reports
• System Development and Validation Creation
- Provide input for and may create or draft CRF design, edit check specification and DM listings.
- Consolidate comments from internal/sponsor for discussion and approval.
- Oversee the entry of data in the Development or QC systems that will be used for validation.
- Perform validation of data management system (CRF content & edit checks) and associated DM reports or listings, and associated change control.
- Provide feedback to other DMs and Programmers to improve the deliverables.
• Maintain or Create Documentation for studies:
- Create and update DM documentation as directed by the DM lead including: Data Management Plan (along with supporting DM documents), CRF Completion guidelines, Data Entry guidelines, Trial Design Document, edit specifications, reconciliation guidelines, and report specifications.
• Study Management:
- Back-up or Primary DM for internal/client team meetings
- Produce and Review Metric reports for internal/external project team
- Provide feedback to improve the system or reports
- Discuss roadblocks for getting processes done in a timely manner
- Review project budgets and staffing projections for data management activities
- Provide the DM lead or PM with status updates on tasks that are assigned

KNOWLEDGE, SKILLS AND ABILITIES:
• Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and
• 2 years preferred, 1 year of clinical data management experience required in pharmaceutical industry, contract research organization, and/or similar industry.
• Team player with ability to work well with technical and clinical team members. Organized and thorough with attention to details. Effective Interpersonal skills and good communications skills, verbal, written and listening. Willingness to learn new things and teach others. Administrative Organization (such as being able to organize/save emails appropriately, etc.). Effective logical thinking ability regarding Problem-solving skills. Proficiency in computer applications: Windows, Excel, Word, Outlook etc. Knowledge of clinical trials data processing concepts. Knowledge of unique data collection concepts (RECIST, CDASH, Local Labs, Adjudication, etc.). Good knowledge of data management processing systems (preferred systems are InForm, Rave, and Oracle Clinical). Ability to interact with entire clinical team (CRAs, Safety, Biostatisticians, etc.) and answer questions related to specific data collection concerns. Ability to create DM study documents (CRF guidelines, trial design document, edit checks, etc.). Ability to perform research for data collection and protocol specific topics. Ability to accept constructive criticism. Ability to adhere to detailed instructions. Ability to work independently.

#LI-Hybrid

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Apply now

Join our Global Talent Network

Let’s stay connected. Join our Global Talent Network to receive alerts when new opportunities become available that match your career ambitions.

Join our network
Top of page