Clinical Trial
This is a full-time employment opportunity for a clinical trial manager (ctm) in the san francisco area.
-responsible for coordinating and monitoring the day-to-day logistics of our clinical trials.
Functions:
-manage clinical trial operations including vendor performance, internal/external metrics, and communication of project status within the project team
-manage and track completion of study start-up, conduct, and closeout activities to industry and corporate standards
-ensure the progress and completion of projects according to timelines
-prepare and present project specific updates
-lead or assist in the writing of clinical documents such as protocols, study reports, study manuals, and annual reports
-monitor safety surveillance and reporting activities
-oversee data management processes including collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation
-coordinate dsmb/safety reviews inline with charter and overall study parameters
-assist in the construction of clinical development processes including development and writing of sops, creation and organization of study trial master files, and clarification of organization and workflow structures
-plan, generate, and track study timelines and trial budgets
-site management activities including: review monitoring reports, interact with study monitors, track site errors or other indicators of site difficulties, identification of potential problem sites and development of corrective action plans as required, acting as our contact, as needed, for clinical sites
experience:
-ba/bs degree in biological science or nursing required (equivalent experience may be accepted)
-5+ years of clinical research in the biotechnology/pharmaceutical industry
-3+ years of multi-center clinical trial management experience, specifically experience in phase 2, phase 3 us & international clinical trials
-experience managing cros, central laboratories, and other clinical study vendors
-experience preparing clinical trial budgets and contracts
-knowledge of ich-gcps and 21 cfr is required
-experience in metabolic/hepatic drug development is desirable
-experience with ivrs and/or edc is desirable
+24 Other ResponsesClinical Data Management
We are looking for clinical data management experts who can provide qualitative insights on the contracting strategy for engaging cdms/edc managed hosting service providers.
In this respect, we would like to understand the benefits and challenges associated with contracting directly with a software integrator vis-à-vis a software provider (such as oracle and medidata). In addition, we would also like to understand the challenges associated with engaging two separate cros to undertake clinical trials and to host cdms/edc platform.
+11 Other ResponsesCro Outsourcing In Clinical Trial
We are a market research company looking for the following information pertaining to cros on behalf of our client:
unique cro outsourcing trends in the clinical trial (cro) industry where cros have been innovative in how they offer services to pharmaceutical companies; real life examples between cros and pharmaceutical companies
preferred or approved supplier for major pharmaceutical companies
how other pharmaceutical companies validate cro rates without going out to bid?
Supplier analysis and market analysis
+24 Other ResponsesClinical Trial Outsourcing
Would like to understand the clinical trial activity list phase wise and activities that could be worked in advance by the sponsors to speed up the trials, while outsourcing to cro's ?
+19 Other ResponsesClinical Data Management Billing Rates
Hi,
i am in need of billing rates for job roles in clinical data management, medical writing and biostatistics for the following countries:
china
philippines
brazil
mexico
i would require the information by 5th feb 2016 (ist timing) as this is a quick request.
Thank you
+19 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 ResponsesClinical Trial Investigation
I'm looking to talk to clinical trial principal investigators, medical researchers who have run or are running clinical trials, about their experiences.
+54 Other ResponsesClinical Research
Hello,
[ subject: identifying best-fit sourcing engagement model - full service v/s functional service outsourcing]
i am currently trying to understand the best-fit sourcing engagement model between pharmaceutical companies and service providers that can provide them with the benefits of cost, quality and speed. I have prepared a specific industry level case study that has three different outsourcing scenarios and want to understand if full service outsourcing or functional service outsourcing is the best sourcing option.
Purpose of the study:
1. Understand best-fit sourcing model for clinical research services (clinical data management and clinical trial monitoring)
2. Understand the pros and cons of using these engagement models
3. Where is the pharmaceutical companies expected to shift in terms of outsourcing model - would it be advisable to go for strategic alliances in the long run?
+30 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 Research
Looking for subject matter experts / consultants in clinical research, clinical trial, risk management, audit and inspection, gcp, clinical outsourcing, trial design and management,ethics fraud and misconduct, patient recruitment , documentation and management, clinical laboratories, facility/hospital , hospital clinical compliance, billing and coding for clinical services , patient/third-party coding and billing, sponsors, cros, clinical quality control/cqc for speaking engagements with over 25+ years of experience. Feel free to reach out to me.
+20 Other ResponsesStandard Operating Procedures For Clinical Trials
• aim is to create an sop for clinical trial diversity - human trials; procedures to follow, develop a program which becomes standard for future trials and diversity elements are incorporated in each trial
• potentially rates for this kind of consulting work
+21 Other ResponsesClinical Research Regulatory Service
• study objective:
to assess the clinical research consulting space with special emphasis on independent review board (irb) services. The aim is to understand the dynamics in the service/product offerings (regulatory compliance, medical writing, strategic affairs, electronic consent manager, meeting scheduler etc.). In addition, we would also like to understand the market overview of irb services comprising of market size, recent trends, drivers, barriers, etc. Focus would be to understand the customer needs, competitive landscape, pricing and market landscape for irb consulting services (regulatory compliance, medical writing, strategic affairs etc.).
• following are some of the key questions:
o what are the different services offered under regulatory consulting in clinical research?
O who are the key users / customers of regulatory consulting services?
O what are the needs for these services of different customers
o what are the factors that influence the customer’s purchase decision of consulting services / products?
O who are the top players providing consulting services and what is their market share?
O what are the billable rates charged on an hourly basis by the companies?
O why, if at all, do the rates differ across various services?
O are there different rates for different customer types? What are the reasons?
O how is the pricing structured for software products such as electronic consent form, meeting scheduler etc.?
o what are the key market trends, growth drivers and barriers to growth etc.?
o where are the key opportunities within the regulatory consulting market?
Preferred expert should meet the following criteria:
o location: us
o industry experience of 15+ years in the clinical research industry
o worked in coordinating clinical trials, device trails and observational studies, regulatory & irb submission, recruitment, data collection and input, source documentation creation, and overseeing good clinical practices (gcp) and ich guidelines
o understanding of clinical studies to ensure compliance with ich/gcp guidelines and federal regulations
o knowledge of regulatory consulting services as well as software offerings specific to clinical trial / research
o understanding of purchase process and pricing structure of consulting services
+12 Other Responses
