Clinical 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 Responses
Currently i am doing a research on rx to otc switch clinical trials.
I request you to provide some insights on rx to otc switch actual use clinical trial market ( market size and region wise split) and supplier market(pricing models for these trials, how these trials are conducted in different regions, drivers and constraints for these trials in different regions, who are the suppliers/cro for these trials in different regions).+9 Other Responses
Clinical Trial Compliance
Looking for consultants on areas like clinical trial compliance with 20+ years experience. To know more feel free to contact me.+16 Other Responses
Clinical 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
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.
-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
-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 Responses
Cro 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 Responses
Board Medical Chair
This is an opportunity for a dedicated medical professional to join our mission of protecting human research subjects as a board chair in our puyallup, washington location.
Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting. Must be authorized to work in usa without visa sponsorship
- provide the highest possible support to our ethical review and research safety programs in areas and issues requiring medical training and judgment. This most commonly involves the institutional review board, and may also include providing medical advice to biosafety committees.
**essential duties & responsibilities**:
- chair board meetings to ensure compliance with federal and state laws as well as our policies and procedures, and facilitate discussion from board members. Provide scientific, ethical and regulatory support and advice to board members
- analyze and present protocols and other agenda items at board meetings to facilitate informed decision making. Set standards and role model effective presentation and discussion for all board members.
- analyze research submissions, identify problems and issues, collect additional information or request corrections, and draft memoranda.
- research, draft, and present reports to the board on a wide range of topics, including but not limited to, investigator misconduct, site visits, fda and sponsor audits of investigators and others, issues involving human subjects, sponsors, and institutions.
- advise clients of applicable scientific information and regulations pertaining to human subject research, both orally and in writing.
- analyze requests for exemption determinations and provide formal written opinions that proposed projects are exempt from the requirements for irb review or do not require irb review.
- provide guidance to clients to help resolve scientific, ethical and regulatory issues and difficulties.
- review literature and other materials to keep abreast of developments in the regulatory, legal, and ethical arenas.
- md or do
- list the medical licenses you currently hold or have held in the u.S
- experience in submitting and/or reviewing clinical trial protocols is strongly preferred. This experience is normally gained while working in the clinical trial industry or as an irb board member.
- experience as a member of an medical ethics review board would be relevant.
- able to chair board meeting and effectively present information to a diverse group of professionals
- six or more years of related clinical experience and/or training, preferred
- ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
- knowledge of ms word, ms excel, ms outlook and ms windows.
Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting. Must be authorized to work in usa.
Kindly respond providing a brief summary of your relevant experience and attach your latest resume on zintro.+44 Other Responses
Clinical Trials Management
This is a 12 month contract opportunity in california: clinical trial manager/sr ctm - asthma
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.
-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.
-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
Clinical Trial Management Software
Topic: clinical trial management software
geographical scope: north america / europe
industry: pharmaceuticals / biopharmaceuticals / generics
job category: it / data management, clinical trial management, corporate management, project management, r&d, formulation, analytical testing
availability: ~1 hour phone interview anytime during the weeks of march 16 – march 27, 2015
we are conducting research on clinical trial software use in the pharmaceutical / biopharmaceutical markets.
We are interested in understanding key reasons, which influence the decision process of choosing one software over another; identifying perceived strengths and weaknesses with regards to the software; and what (if any) are suggested improvements or innovations currently lacking in the clinical trial software market.
Qualified respondents must work for a company that currently utilizes clinical trial management software and possess familiarity of the software’s user interface.
Additionally, we are interested in speaking with persons who are currently working in the software / services market in order to obtain a more complete picture of the types of drivers which customers are looking for when searching for clinical trial software.
If you feel you can offer insights into this area of research please contact us immediately as we only require 8 candidates for this portion of the research.+18 Other Responses
Therapeutics Clinical Operations
Director, clinical operations. This is a full time employment opportunity in california,usa.
Provide key clinical support for the operation and execution of clinical trials for clinical programs. Ensure compliance and completion of the following clinical drug development activities:
-requires minimal supervision to manage various activities associated with multiple clinical studies
-working knowledge of fda regulations and ich guidelines to ensure compliance with both during clinical trial conduct
-has had experience as clinical operations lead on significant phase i or phase ii programs
-participates in evaluation and selection of cro’s, contractors and other outside vendors, and the development of budgets. Manages cros and vendors, as appropriate
-manages efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in partnership with the director of oncology clinical development
-independently designs or assists in the development of study related documents including but not limited to: case report forms, case report form completion guidelines, study manuals and project tools, monitoring plans, tracking tools, informed consent forms, and study reports
-may prepare study-specific training materials or slides for investigator meetings
-contributes as part of the clinical protocol development team
-ba/bs in science-related field with 10 + years’ experience in clinical operations /trial management or a combination of relevant related work experience
-demonstrated thorough understanding of fda regulations and gcp and proven success record in managing trials+19 Other Responses
Medical And Clinical Trial Billing
Hands on experience in setting up medical and clinical trial billing. Must have experience in marketing and handelling of business. Must have technical knowledge+3 Other Responses
Late Phase Clinical Trials
Clinical trials - late phase studies cost benchmarking
we are looking for experts in the late phase (phase 4, post marketing) area of clinical trials. We wish to perform cost benchmarking and kpi benchmarking for different aspects of phase 4 studies. We also want to understand the sourcing practices for different scenarios e.G. (tactical vs. Strategic; local vs. Global etc.)the details are mentioned below.
• per submission cost benchmarking for cta submissions
• per dossier cost benchmarking for dossier publishing
• per patient cost benchmarking for interventional trials
• per patient cost benchmarking for nis trials
• key service level kpis and performance benchmarks
• sourcing practices for different scenarios (e.G. (tactical vs. Strategic; local vs. Global etc.))
therapeutic areas: (oncology, respiratory, neuroscience, infectious)
geographies: india, china, uk, brazil
vimal+11 Other Responses