PSG Global Solutions Careers
Sr. Associate, Clinical Trial Management
PSG Global Solutions Careers, Irvine, California, United States, 92713
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Sr. Associate, Clinical Trial Management , working in
Pharmaceuticals and Medical Products
industry in
2525 Dupont Drive, Irvine, California, 92612, United States .
Job description:Assists the CTM/OSL and FACT team with regional study feasibility, the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required.Assists the CTM/OSL in region-specific document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrollment initiatives; and planning regional clinical study supplies. They assist in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor.Assists the CTM/OSL in regional financial management; database lock activities; regional study drug management; regional trial master file management; regional study enrollment management (e.g. contingency plan execution); ongoing review of protocol deviations; regional vendor management; and ensuring adverse event reporting.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Requirements:
Science degree preferably in science or health-related fieldPrevious experience of working on a clinical studyOversight or mentoring of more junior study monitors (direct or indirect) preferredPrior experience in device clinical research, ophthalmology and/or medical aesthetics a plusGood understanding of Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations)Knowledge of concepts of clinical research and drug/device development
What Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
Sr. Associate, Clinical Trial Management , working in
Pharmaceuticals and Medical Products
industry in
2525 Dupont Drive, Irvine, California, 92612, United States .
Job description:Assists the CTM/OSL and FACT team with regional study feasibility, the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required.Assists the CTM/OSL in region-specific document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrollment initiatives; and planning regional clinical study supplies. They assist in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor.Assists the CTM/OSL in regional financial management; database lock activities; regional study drug management; regional trial master file management; regional study enrollment management (e.g. contingency plan execution); ongoing review of protocol deviations; regional vendor management; and ensuring adverse event reporting.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Requirements:
Science degree preferably in science or health-related fieldPrevious experience of working on a clinical studyOversight or mentoring of more junior study monitors (direct or indirect) preferredPrior experience in device clinical research, ophthalmology and/or medical aesthetics a plusGood understanding of Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations)Knowledge of concepts of clinical research and drug/device development
What Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?