AS GLOBAL DATA MANAGER YOUR ROLE WILL INVOLVE GAINING EXPERIENCE OF ALL ASPECTS OF GLOBAL CLINICAL DATA MANAGEMENT AND CERTAIN RELEVANT ASPECTS OF CLINICAL RESEARCH.
You will be part of an intensive training and development program and with selected mentoring, you will have the opportunity to develop the skills necessary to perform in the role of a Global Data Manager. As an Global Data Manager you have an opportunity to bring positive impact to patients health care and well being. You will utilize your scientific background and make an immediate contribution to the world of clinical trials.
It is expected that in the Global Data Manager position, you will gain knowledge, skills and experience required for the job through comprehensive training under guidance of experienced personnel and will be involved in the following activities :
Works with Contract Research Organization (CRO), the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned clinical trial(s).
With the trial customer, CRO and other functional partners:
Performs trial level oversight controls as described in the oversight plan, quality control (QC) process, and work instructions.
Reviews clinical data management documents (including submission package) for appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Works with team to facilitate compliance with regulatory guidelines and the documentation matrix.
Works with team to facilitate real-time inspection readiness of all IDS deliverables for the trial. Participates in regulatory agency inspections and J&J internal audits as necessary.
Works with team to plan and track content, format, quality, and timing of data management deliverables, including, but not limited to eCRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Works with team to ensure deliverables are on time.
Supports the assigned clinical working group(s) to ensure that trial needs and deliverables are met.
Identifies and communicates lessons learned with support from team lead.
Participates in process, system and tool improvement initiatives.
Presents at investigator and monitor meetings.
EDUCATION EXPERIENCE:
Minimum of a Bachelor’s degree in a Life Sciences curriculum or a related field.
Recent college graduate (must be within 1 year of graduation).
KNOWLEDGE, SKILLS AND ABILITIES THAT WILL BE USED AND/OR DEVELOPED:
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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