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
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
Oncology Clinical Trial
We would like to understand the % difference of per patient cost for oncology clinical trial and a rollover oncology trials.+17 Other Responses
Pricing Models For Phase Iii Clinical Trials
We are conducting a study on the various pricing models prevailing in the industry for phase iii clinical trials and also how is the milestone pricing model being adopted and received currently. Would be glad to understand on the various milestones/ goals that are setup for the periodic payments in the milestone model and also what are the various payment/ pricing models prevalent in the industry?+8 Other Responses
Early-stage Oncology Clinical Trials
oncology clinical trial managers, organizers, site coordinators, trial investigators/consultants;
oncology clinical trial regulatory personnel; clinical project manager/consultant at cros and pharmaceuticals
priority regions of interest: united states, europe, india
few companies involved in this space: cros conducting early-stage oncology clinical trials (e.G., lambda therapeutic research, labcorp, ppd, iqvia, syneos)
few clients involved in this space: small-to-mid-sized pharmaceutical companies in oncology field (e.G. Novartis, amgen, astrazeneca, bms, biocon, incyte)
the some of the key aspects that we are looking to understand from the experts are (global and india):
o market size and segmentation (value and volume) of oncology clinical trials:
• historic & future growth rate
• market trends/drivers & challenges
• impact of covid-19 on the market demand
o regulatory overview of the indian clinical trial market:
• regulatory submission and approval process
• necessary sops– protocols & guidelines: prerequisites to conduct a clinical trial in india for indian and foreign molecules and medical devices
• mapping of application and approval process: clinical trial commission, trialist and registrant application, necessary documentation required, phase i / ii data review, feedback and institutional ethical committee approval
o assessment of market structure and identification of key cros
• evaluating the market structure for the early- stage oncology trials by the cros and sponsors
• identification of key cros that conduct the early- stage oncology ct globally and in india
• competitive assessment of key cros (lambda research / labcorp / ppd, etc)
• business overview and offerings of the key cros in this space
• information on technologies used for patient recruitment, risk based monitoring, patient monitoring, etc.
• proficiencies in biostatistics and statistical programming, clinical data management
• business model and strategic outlook within the oncology space
• type of customers and services provided
o customer assessment
• identification and segmentation of the key customers (mid – small pharma clients)
• evaluating current and future customer requirement and challenges faced by them+32 Other Responses
Standard 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 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
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.+45 Other Responses
Clinical Trials Ai Platform
We are looking for experts who can provide their insights and feedback to a startup seeking equity investment.
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:
healthcare, clinical trials, pharmaceutical, life sciences, health and wellness
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 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
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
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