Senior Clinical Data Manager

  • Location
    Irvine , California
  • Category
    Engineering - Scientist
  • Job type
    Contract/Temporary

Adecco Medical & Science, a leading provider of contract and permanent staffing in the Pharmaceutical, Life Science Technology, Medical Device, and Health Care industry is seeking an experienced Sr Clinical Data Manager to work within one of our leading pharmaceutical clients in Orange County.

Description
The Senior CDM (Clinical Data Manager) will provide specialized knowledge and detailed attention to carry out data management activities in support of one or more clinical research studies.

Responsible for executing the design, documentation, testing, and implementation of data collection systems and processes in support of the clinical study teams. Assist with development of clinical data management study documentation (e.g. Data Management Plan, Edit Check Specifications, etc.), and supporting the review in accordance with existing standards.

Responsible for the execution of the data review strategy for one or more studies as defined by the individual study Data Management Plan. Involved in Data Management Data Review activities and other Clinical Study Team Data Review (e.g. Masked Data Review). Initiation and management of the data clarification process, coordinating with other stakeholders to ensure appropriate resolution to all data clarifications prior to database lock.

Implementation of quality, efficient, and consistent approaches to carrying out clinical data management tasks. Delivering training to clinical data management and other departments, as necessary.

The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all policies, and procedures.

Qualifications

Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field: 6 years experience, or BS/BA degree with 4 years experience, or MS degree with 2 years experience.
Minimum 2 years experience within a clinical data management organization, preferably within medium-large pharma or CRO.
Knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials
Knowledge of Research & Development and an understanding of regulatory guidelines/requirements related to R & D (e.g., ICH, GCP, safety reporting)
Working knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.).
Working knowledge of EDC (preferably Phase Forward InForm) would be highly desirable.
Competencies and skills in the following: cross functional relationships, communication, decision making, execution/results/process improvement, customer satisfaction
Ability to effectively interact with and influence others without direct reporting relationships
Ability to multi-task and prioritize
Planning, organizational, and project management skills
Document writing skills
Attention to detail with high quality outputs
Proactive and critical evaluation of varied and multiple aspects of trial implementation to ensure timely completion and with requisite quality
Ability to meet challenging milestones
Analytical and problem solving skills
Computer skills (word processing, spreadsheets, graphics, PowerPoint)


if you are interested please email your resume to Anthony at anthony.williams@adeccona.com or call 925-349-0308





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Reference number US_EN_2_108175_240267