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Clinical Data Associate all levels I / II /III
Company: INC Research
United Kingdom, Battle East Sussex UK
Ref: EP063-09
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About the Company :
| We are an organization composed of therapeutically-focused high performance teams led by world-class project managers and leaders, dedicated to helping our Customers bring products to market in order to improve world health |
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About the Job :
Clinical Data Associate all levels I / II / III
SUPERVISOR:
Group Manager/Data Management Team Leader/CDA III
Works with Lead Data Manager to analyze and document databases and perform system testing. Performs Clinical Data Management (CDM) review of all study subject information captured during the conduct of a clinical study. Works on a project team and complies with all Standard Operating Procedures (SOPs)/work Instructions (WIs), regulatory guidelines and directives, and study specific plans pertaining to collection, review and management of clinical study data.
ESSENTIAL JOB FUNCTIONS:
1. Reviews and adheres to the requirements of study-specific Clinical Data Management Plans which meet sponsor specifications.
2. Assists and contributes to the compilation of Clinical Data Management Plan documentation and clinical database user testing documentation as requested by Lead Data Manager.
3. Prepares test data for user testing of database screens and edit checks.
4. Participates in study-specific data entry training and serves as backup to data entry staff.
5. Performs clerical and administrative support tasks for the CDM group.
6. Performs clinical study data review as required by Clinical Data Validation Plans.
7. Manages data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely manner as part of the study team.
8. Verifies database changes as requested by Lead Data Manager.
9. Updates clinical database based on queries, site-generated Data Clarification Forms, discrepancy management guidelines, and performs other database changes as directed by an experienced study data manager and in accordance with established guidelines.
10. Prepares relevant subject data files for internal audits and quality control.
11. Maintains proficiency in use and analysis of data entry system and performing systemic data management review tasks and overall awareness of CDM practices by reading related literature, attending training classes and professional meetings, and participating in project-specific training sessions.
OTHER DUTIES:
Performs other work related duties as assigned. Minimal travel may be required (up to 5%).
EDUCATIONAL/SKILL/EXPERIENCE REQUIREMENTS:
Requires a minimum of a B.S./B.A. degree in the biological sciences or related disciplines in the natural science/health care field or equivalent plus a minimum of 0 – 6 months in professional, health care or clinical research setting, or AA/AS and 1 year of health care or clinical research experience with some experience directly related to clinical data management and related systems, or equivalent combination of education and experience that provide the skills and knowledge necessary to perform the job.
Working knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices is advantageous. Requires effective oral and written communication skills, presentation skills, and attention to detail. Experience with relational database management software systems is required. Requires proficiency in Word, Excel, and Email. Ability to multitask under deadlines and work as part of a multi-disciplinary team as well as independently. Ability to be flexible and adapt to change.
PHYSICAL REQUIREMENTS:
Position requires: ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. The noise level in the work environment is low.
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Profile of Ideal Candidate :
Proven knowledge of working within a CRO Pharmaceutical or Healthcare company
CDA I 18/23000pa
CDA II 25/28000pa
CDA III up to 35000pa
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