Blinded Clinical Trials
I am looking for an expert who can guide me about the un-blinded monitoring process in blinded clinical trials and help me understand how pharma companies approach un-blinded monitoring. Do they source from a single supplier/multiple suppliers or do they appoint an in-house un-blinded monitor.
Please get in touch asap. This is a little urgent.
Thanks!
+11 Other ResponsesClinical Trials Ai Platform
We are looking for experts who can provide their insights and feedback to a startup seeking equity investment.
Startup description:
design & conduct better clinical trials. Making clinical trials seamless by bringing together the best and most important functionality of study design & protocol optimization, trial administration, data collection & task management all in one intelligent system.
Experts that have interest, knowledge or background in:
industry:
healthcare, clinical trials, pharmaceutical, life sciences, health and wellness
technology:
healthcare it, deep learning, ai, end-to-end platforms
who we are:
we are an online investment platform working to provide a fair and transparent process for startup evaluations and that selects the companies that will outperform other startups in the next three to ten years.
Who you are:
you do not need to be an experienced angel investor to be a valuable member of the evaluation team. We seek a diverse group with expertise that may cover the market, business model, technology and customers of the startup company. However, if you are an accredited investor, you have the option (but not an obligation) to invest as little as $1000 fee- and carry-free in the startup company if the resulting evaluation leads to an investment.
What you will do:
as a participating evaluation team member, you will answer a set of questions and rate the comments and feedback of other evaluators.
(this is an all volunteer community of industry experts and investors that evaluate startups, requiring about 2 hours total of your time over about 2 weeks.)
what’s in it for you:
- an inside look at cutting-edge technology or go-to-market approaches
- introductions to company management, upon request
- collaboration with like-minded experts who are on your evaluation team
- contributing to creating a fairer, more-informative process for startups seeking investment
+29 Other ResponsesClinical 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 Responses
