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 Responses3d Printed Drug
Hi zintro expert,
the zintro blog needs you! we are looking for expert opinions on the news mentioned below and would like to include your point of view. We realize your time is valuable, so here is a brief summary of what we are looking for:
*a brief answer to the prompt about 1-2 paragraphs including your full name
*participation is voluntary no payment will be involved
*if chosen, you will be named in the post and we'll include a link to your zintro profile which will generate more visitors for you
topic and prompt
this week the us food and drug administration (fda) gave the go ahead to the first 3d-printed drug, spritam, which is designed to treat seizures brought on by epilepsy in adults and children. It was developed using zipdose, a 3d printer that creates ills by printing out thin layers of medicine in powder form, with layers of a water-based binder spread between each of the powder layers. The result is a tablet that can dissolve with a sip of water in less than five seconds. Spritam will be commercially available from early 2016 onwards.
Do you think 3d-printed drugs could have the ability to transform the pharmaceuticals industry.
Getting your name and expert opinion published on our blog is a great marketing opportunity. If interested, please send a response to the prompt via znotes within 1-2 days. Don't forget to include your full name.
If you have any questions, please let us know.
Thank you!
the zintro blog team
wondering what the post would look like? Here is a sample:
http://blog.Zintro.Com/2014/08/14/rosetta-completes-10-year-trip-deep-space
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+3 Other ResponsesOncology Steroids And Hormone Drugs
I am looking for a production manager/consultant who have complete on hand experience in production of oncology, steroids and hormone drugs. However, comprehensive technology is also appreciated.
Thank you
+6 Other Responses
