Clinical Trials Management
This is a 12 month contract opportunity in california: clinical trial manager/sr ctm - asthma
overview:
responsible for managing the full scope of proper study conduct including, but not limited too, protocol development to final report, regulatory filing and/or publications, coordinating cross functional efforts in the administration and progress of phase 1 to 4 clinical trials. Additional responsibilities include trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.
The incumbent will use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. May determine methods and procedures on new assignments. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Responsibilities:
-lead clinical trial project execution for asthma programs to ensure that trial timelines, costs, and quality metrics are met.
-serves as primary contact for functional area representatives in managing protocol execution.
-manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
-forecast and oversee clinical supplies, e.G. Study drug.
-manage study milestones to ensure accurate tracking and reporting of study metrics.
-oversee ongoing service provider management (e.G., cros, ivrs, central labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
-create and manage clinical trial budgets in collaboration with manager and the vice president of clinical operations.
-may provide study-specific direction and mentoring to cras and ctas.
-collaborate with clinical quality assurance to maintain quality standards in compliance with regulatory requirements/guidance’s and adherence to sops and ich/gcps; participate in ongoing process improvement initiatives.
-manage adherence to ich/gcp/local regulations.
-participate in clinical operations initiatives and programs.
Qualifications:
-bachelor’s degree with at least 5 to 8 years of cra experience for the manager level with at least 1 year of staff management experience. The senior manager level requires 10+ years of combined cra and ctm experience and 3 years direct staff management experience is required.
-experience in inflammatory diseases, specifically asthma and/or chronic obstructive pulmonary disease (copd) is required.
-experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
-extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
-team oriented and collaborates effectively with the clinical operations study team, cross-functional team members, and external partners.
-working knowledge of ms project for development and update of clinical study timelines.
Contact us here on zintro for further details.
+17 Other ResponsesScientist Ii/iii
Our company is seeking an experienced, motivated, self-sufficient scientist ii/iii for a position based in tyler, texas, usa. the ideal candidate will have significant expertise and a broad background in cellular biology, use of animal models, biochemistry and pathway analysis involving peptides and proteins in pulmonary fibrosis, in particular, and fibrotic disease, in general.
The position is funded to carry out research plans relevant to the advancement of product development. The position is physically located in wet lab space based at the biomedical research facility in tyler, texas. Candidates should be able to demonstrate a track record of independent productive research, show willingness to help guide junior lab members, have strong organizational, written, and verbal skills, and possess the ability to work both independently and as part of a laboratory team.
Responsibilities
• develop, implement and execute both animal and cellular models to test efficacy and inform the molecular mechanisms affecting fibrosis in mammalian cells tissues, primarily of the lungs.
• rapidly onboard existing protocols and improve/augment as required
• relies on experience and judgment to plan and accomplish goals carrying out experimentation oneself
• independently design or otherwise execute studies to understand proteins and cell signaling pathways associated with tissue remodeling and fibrosis.
• evaluate and incorporate whenever possible cutting-edge technologies and models to drive creative molecular/cellular research.
• accountable for project execution, communication of results to pharmaceutical industry standards and follow-up
• collaborate broadly with members of the program teams based in austin, tx and with collaborating research groups based in tyler, tx.
• prepare and present findings at company and collaborator meetings
qualifications
• ph.D. In biochemistry, cell biology, molecular biology or in vitro pharmacology, or a relevant biological field with at least 5 years of industry and/or academic experience investigating mechanism of modulation of cellular pathways preferably working with proteins and peptides
• demonstrated understanding of molecular biology, cell biology and biochemistry and hands-on experience with current techniques in protein/peptide isolation, northern/western blotting, qpcr, biochemical assays, histological sample preparation, and mammalian primary cell culture, and their use in dissecting biochemical pathways
• must have experience with in vivo animal husbandry and experimentation in rats and mice including dosing, biological sample collection, terminal procedures, multiple time point sample collections, for example for pk studies
• experience in pulmonary fibrosis specifically and familiarity with fibrotic diseases in general is necessary
• excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment
• ability to multi-task to meet aggressive technology development and research goals
we can offer a varied, fast paced and interesting experience as a key contributor in growing company. We are committed to high quality, timely, well-documented science to meet our aggressive corporate development plans. in addition to competitive salaries we offer an attractive benefits package including medical, health & short-term disability insurances and a “flexible within reason” leave schedule up to 3 weeks per year.
+5 Other ResponsesPulmonology And Tracheotomy
I am currently working on a medical malpractice law suit. The patient with tracheostomy died due to negligence on the part of a home care nursing agency. The patient's tracheostomy tube wasn't suctioned, a mucus plug formed. The air passage way was obstructed, and the patient died because of cardiac arrest. We need a pulmonologist expert witness based in south florida who is familiar with this type of case.
+4 Other ResponsesFluoroscopy Device Usage
Requesting to speak with independent imaging center or hospital radiology director or equivalent to understand fluoroscopic device usage and utilization within the center. Respondents should be able to answer questions pertaining to their fluoroscopic model and its current usage within their facility. Here are some sample questions we may be discussing:
1) how many fluoroscopy procedures are done at your facility in 2016?
2) of all the fluoroscopy procedures you do, what is the percent usage by the following indications? (cardiovascular, pulmonary, gi etc.)
3) when these procedures are performed for these specialties, where do they occur in the hospital?
If you are comfortable answering these questions and would like to participate in this study, please reach out to me. Compensation is offered for your time and insights.
Thank you.
+6 Other Responses
