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Clinical Research Specialist II
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Clinical Research Specialist II

Job Description

We are seeking a Clinical Research Specialist II who reviews clinical data/information and oversees data correction. Assists study managers in providing interim and final reports and presentations. Provides input to study budgets and project plans. Assists study manager in writing PMA Clinical Reports. Work with the Clinical Study Manager to satisfy applicable regulatory standards. Designs, plans and implements the overall direction of clinical research projects. Evaluates and analyzes clinical data. Serves as a medical/scientific consultant to marketing or research project teams and government regulatory agencies. Monitors and/or interprets results of clinical investigations in preparation for new drug application or device application. Establish the conditions essential for determining the safety, efficacy, medical usefulness and marketability of drug or medical device and product candidates.

POSITION RESPONSIBILITIES:

Attend monthly data dissemination core team meetings and provide input into publication strategies and data availability. Review/QC content against source data (MDT data or other published data). Review/Revise content for alignment with key messages. Interface between OMA, RA, Mktg, Health Econ groups on data dissemination strategies, content, timing, etc.

Job Requirements

The ideal candidate will need the following:

REQUIRED QUALIFICATIONS:

Excellent understanding of clinical trial subject matter. Good understanding of biostatistics and trial design. Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology. Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 and 14155:2011. Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH).

Ability to independently lead the data dissemination activities for a new product with little supervision. Strong understanding of the therapy or ability to learn quickly. Innovative - not afraid to think "outside the box." Customer focused. Takes ownership and self-motivated. Works effectively on cross-functional teams . Results and solution oriented . Strong project management skills . High attention to detail and accuracy. Good prioritization and organizational skills Proficient in MS Office products, word processing, spreadsheets, etc.

Job Snapshot

Employment Type Contractor
Job Type Biotech
Education 4 Year Degree
Experience 3 to 5 years
Manages Others Not Specified
Relocation No
Industry Medical Equipment
Required Travel Not Specified
Job ID lvATR98904
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Clinical Research Specialist II


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