Kendle India: Apply for Clinical Data Associate post

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Kendle India: Apply for Clinical Data Associate post

Kendle India: Apply for Clinical Data Associate post
 
Kendle International Inc. (Nasdaq: KNDL) is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world’s biopharmaceutical industry. Our focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing products to market for the benefit of patients worldwide.

As one of the world’s largest global providers of Phase I-IV services, we offer experience spanning more than 100 countries, along with industry-leading patient access and retention capabilities and broad therapeutic expertise, to meet our customers’ clinical development challenges.
 
This is an exciting time to join Kendle as our India offices continue to grow as a result of new business wins. The role of the Clinical Data Associate is to review and process clinical trial data to ensure the accuracy and consistency of clinical databases.

Clinical Data Associates Level I
 
* Location: India
* Job ID: KIND6958
* Area of Interest: Clinical Data Management
* Job Type: Full-Time Regular
* Education Required: Not Indicated
* Experience Required: Not Applicable
* Relocation Provided: Not Indicated
 
Core Responsibilities
 
* Performing tasks with minimal error, within timelines and according to Clinical Data Management (CDM) Project Plan, SOPs and Sponsor specific requirements.
* Tracking and reconciling data received for in-house review through use of existing CRF tracking tools.
* Applying corrections and/or updates to the clinical database and appropriate documents (original and/or working copies of CRFs for paper studies) which are identified through query resolution, data entry, text review, study conventions, site request, computerized validation, and/or data importing.
* Performing reconciliation of similar data between multiple data sources.
* Reviewing listings to check accuracy and completeness of clinical data.
* Performing internal Clinical Data Management QC audits of the clinical database against the CRFs including query results for paper studies.
* Demonstrating consistency and good judgement in resolving data discrepancies by applying study conventions accurately and in the correct circumstances, raising clear, accurate queries when conventions are not appropriate, resolving queries correctly answered and re-querying issues which require further information.
* Completing tasks within timelines by appropriately prioritizing multiple tasks within or across projects, minimizing backlog and managing time constraints across projects.
* Proactively communicating accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts.
* Assisting Clinical Data Management in the identification of clean patients for internal CDM QC. Creating QC listings from clinical database.
* Participating in the review of final data listings, tables and graphs to facilitate validation of the clinical database, when required.
* Operating computer software relating to safety coding.
* May assist in coding clinical trials data (e.g., adverse events, medical history, physical examination, and/or medications) for projects where Kendle CDM is responsible for coding safety data.
* Recognizing data management project issues which may compromise timelines and quality and communicating them in a timely fashion to CDM study management.
 
Skills & Attributes
 
* Applications will ideally have a minimum of a Bachelors degree coupled with industry experience.
* Candidates must be computer literate and possess good verbal and written English language skills.
* An ability to work across multiple projects concurrently is an advantage.