Pharmaceutical Jobs - Clinical Research Jobs

Position

Clinical Data Associate III (CDA III) x 4 - Battle-UK

Company

INC Research

Location

Battle

Country

United Kingdom

Job Description

Clinical Data Associate III (CDA III) x 4 - Battle

The CDA III will perform complex Case Report Form /electronic Case Report Form (CRF/eCRF) data review in compliance with Standard Operating Procedures / Work Instructions; regulatory directives; and study specific plans and guidelines. The CDA III will also perform essential functions which support the CRF database testing, as well as additional data management activities such as CRF/eCRF design, external data reconciliations, and review of database designs within an appropriate mentoring and training program.

ESSENTIAL JOB FUNCTIONS:

Maintains awareness of the pertinent elements of contract and scope of work for assigned projects.

Reviews and adheres to the requirements of study-specific Clinical Data Management Plans.

Enters test data for data entry screens and test data for edit checks.

Performs review of discrepancy (edit check) output and validation listings based on data entered into the CRF database. Based on this review will issue Data Clarification Forms (DCFs) or apply self-evident corrections or other global rulings permitted in cases where DCF issue is not required, per the Clinical Data Validation Plan for the assigned projects.

Reviews draft DCFs.

Issues DCFs to sites.

Takes receipt of, and reviews, DCFs that have been answered by sites. Where appropriate, edits the CRF database accordingly.

May code investigator terms for adverse events, medical history, and medications using medical coding dictionaries, designated software and electronic dictionaries. Tests such coding processes function correctly for each assigned project

Ensures that data from external databases/datasets such as laboratory databases, or electronic diary datasets are consistent with data held on the CRF database. Uses the specified process to document and query any such discrepancies found with the appropriate party.

Ensures all Case Report Forms (CRFs) and Data Clarification Forms (DCFs) received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.

Participates in meetings and audits.

Trains and mentors less experienced data management staff.

May design, or review designs, for CRF pages and eCRF entry screens and associated CRF / eCRF visit structure, indexing and version control.

Reviews database design specifications and CRF and eCRF Completion Guidelines

Trains project team in project specific requirements.

Resolves issues arising from quality control checks on listing output from database against CRFs and DCFs.

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:

Ideally a degree in the biological sciences or in the natural science/health care field with clinical data management experience. However, in some cases, a combination of past performance and prior related experience may be considered provided that the individual demonstrates the outlined knowledge, skills, and abilities to perform the job duties.

Proficiency in MS Windows. Experience with Clinical Data Management practices and relational database management software systems required. Direct exposure to Oracle Clinical, RAVE, or Inform systems required. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices essential. Excellent speed and accuracy of keyboard skills. Effective oral and written communication skills, and presentation skills. Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail; ability to be flexible and adapt to change; ability to work independently, as well as part of a multi-disciplinary team.

We offer a competitive salary and comprehensive benefits package. For immediate consideration, please email your CV with salary requirements to: (Email submissions preferred.)

Company Profile

INC Research is a therapeutically focused global contract research organization (CRO) with unrivaled expertise and a reputation for conducting global clinical development programs of the highest integrity. INC Research has a deep-rooted history of therapeutic expertise and technological innovation. Founded more than two decades ago as an academic research organization focused on CNS research, we've translated that expertise into a global organization with the added specialties of infectious diseases, oncology and pediatrics, as well as full data services capabilities.

Job Type

Full Time

Salary

Upto 0 Ł Per Month

Skills Required

Clinical Data Management

Reference

CDAIII/Battle

Posted On

24 November 2009

Last Date to Apply

25 December 2009

Important Notice

For jobs based in the EU it is unlawful to employ a person who does not have permission to live and work in the EU. Unless the job advert states otherwise, please ensure you have this permission before applying.

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