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 ResponsesRespiratory Therapy Market
Our us firm requires 1-3 experts in the ventilator/respiratory therapy market for paid phone consultations.
An ideal expert would be familiar with the non-invasive pressure support ventilator market specific to individuals with copd or als.
Referrals are also welcomed, thank you.
+5 Other ResponsesCystic Fibrosis
We are a research organization based out of new jersey, usa and provides market research services, which include ad-hoc or customized qualitative research, quantitative research and long-term tracking studies.
We are conducting research with key opinion leaders (kols) globally on the topic of cystic fibrosis.
• objective: research is related to the discussion of future directions in the management of cystic fibrosis. More specifically, we would like to talk about how cystic fibrosis treatment is likely to evolve and the role of specific investigative therapies.
• confidentiality: please note that being affiliated with esomar (european society of opinion & market research) we are bound to confidentiality and none of the opinions expressed by you will be aligned with you or your organization unless we have an explicit written permission from your end.
• methodology & duration:
o in-depth interview: the interview will take place by phone and may take around 60 minutes
o dyads/triads: telephonic dyads/triads around 90 minutes
o needs to have access to internet for us to share materials during interview/dyads/triads
• profile:
o must have published papers on cystic fibrosis in international journals
o must have been a speaker at national/international conferences
o must be a lecturer/professor with reputed university
o must be based in canada or western european countries only
regards,
our research team
+5 Other ResponsesAsthma Detection
We are looking for experts in "asthma detection" to provide commentary and insights towards a startup that developed an engaging and user-friendly portable spirometer and gamified app with hospital reliability, for children to detect early signs of asthma attacks.
We are an angel investing platform dedicated to connecting deep-tech startups with angel investors. By deep-tech we mean startups founded on scientific breakthroughs and technological innovations that create lasting impact on mankind.
As a participating expert* in this process, your involvement is limited to answering anywhere between 8-12 investor-submitted questions. This takes about 1 hour (+/-) . Once you are vetted, we send those questions via a web form for your responses. If your contribution is published, it will be view-able by potential investors in this startup, giving you an opportunity to make connections, socialize virtually, and gain bragging rights in a vibrant entrepreneurial and angel investing community.
*at this point, we cannot guarantee any monetary reimbursement. You do get insights to new upcoming technologies in your field and a tremendous networking opportunity!
+13 Other Responses
