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
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
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 Investigators
We are looking for an expert who can help us do a clinical trial investigator fees / role benchmarking.
1) standardize how high range benchmarks are calculated for investigator fees; e.G. What percentile (50th, 75th, 80th, 90th, 100th ) is used by each segment of the industry to set the upper limit for investigator fees benchmarks
2) is inflation included in the calculations? Is this assessed every year or projected at the time of the contract.
3) how are companies organized around the generation of fmv (per segment/ per region where applicable)? Centrally managed by internal team? Part of operations or stand alone
4) to what level is fmv assessed? Line item, visit, patient; how is overhead assessed is there a company maximum? What is the governance for companies that are above the upper limit of the benchmark for fmv
5) how are the negotiations managed with the investigators? Centrally by internal team, decentralized through regional functions, cro only, specific service provided by specialty vendor, online tool?
6) what is tco for other companies per segment?
7) how are the contractual obligations managed? (automatic feed to electronic data, investigator tracking on central database?)
8) what are the triggers for payment release of investigator fees? Is it recruitment, visit completion, availability of data/clean data?
9) is the processing of invoices from investigators managed centrally (specialist team receiving information from all investigators worldwide?)
10) how are investigators paid?+undefined 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
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
Clinical Drug Trials
I am looking for a medical expert in neuropathic pain for due diligence on a clinical drug investment opportunity we are considering+16 Other Responses
Oncology Clinical Research
Head of oncology clinical research: this is a full time employment opportunity in california, usa.
The clinical research physician will play a key role at all stages of development for programs from the drug discovery stage through clinical development, world-wide. In addition, this role will have responsibility for planning, executing, and interpreting clinical trials within the oncology therapeutic area. The successful candidate will report directly to the cso and head of research & early development, who has responsibility for the overall research and development strategy.
Essential duties and job functions:
assumes primary responsibility for all scientific and operational aspects of conceptualizing, planning, initiating, executing and completing trials, and participates in establishing clinical strategy for the company
manages the clinical research component in the preparation/review of regulatory documents, ind annual reports, ind safety reports, investigator brochures, and development plans
provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
coordinates the collection and analysis of clinical data for internal analysis and review, and manages the preparation and/or review of data listings, summary tables, study results, and study reports
knowledge, experience and skills:
-md or equivalent
-title of position will be determined by depth and breadth of experience and skills of the candidate. --a proven success record in independently planning, designing, and executing clinical research studies is required
-relevant industrial or academic experience in clinical research with basic understanding of and competency in good clinical practices
-experience in oncology drug development (minimum of 3 years)
contact us here for more details.+3 Other Responses
Benchmarking Practices Within Clinical Trials
I am looking to get more information on the concept of benchmarking as a practice with a specific focus on how pharma companies are using the practice of benchmarking to identify opportunities within their clinical trial practices, resource management, patient engagement, and portfolio management.
I would like an overview on the various kpis / benchmarking parameters considered by pharma for each of the below categories along with case studies,
• for an outsourced clinical trial service kpis such as regulatory timelines, patient pool, economic risk rating of country, supplier availability etc., are considered
• for recruitment/resource management, we can provide the kpis used in recruitment and management of resources such as attrition, annual turnover, retention rate, co employment risk etc.
• for patient engagement, pharma companies are relying on digital platforms to help improve retention (e.G. Ar, vr, gamification and the like and outsource to specialists – paragon solutions). The key parameters considered are therapy, financial assistance, clinical trial participation, patient access and education.
• portfolio management benchmarking is key and this is done based on number of compounds, therapeutic areas, stage of development, decision tree analysis etc.
Thank you+undefined 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
This is a full-time employment opportunity onsite in montreal, qc, canada.
**as a manager, biostatistics you will:
- implement project-specific strategies and assist with the development and implementation of department strategies to increase productivity and quality, while decreasing cycle times and costs.
- assist with the oversight of statistical operations personnel. This includes hiring personnel, managing personnel matters, conducting performance evaluations, and training statisticians regarding applicable regulatory guidelines and statistical practices.
- participate in interactions with regulatory agencies and assist with resource allocation and the development of business proposals related to the biostatistics and programming department.
- be responsible for the statistical aspects of projects for clients and project teams through management of internal staff. Provide input into crf and dvs development in all therapeutic areas (e.G. Edit checks for clinical trial data).
- serve as the statistical lead on projects when appropriate and develop a close liaison with the client contacts, sas programmers, biostatisticians, and project managers to drive the statistical aspects of project delivery.
- and more!
**required education and experience**
- phd in statistics, biostatistics, or related field with some applied statistics training relevant to the clinical trials or health research environment and with 3 years of relevant work experience or a master’s degree in statistics, biostatistics, or a related field and 5 to 7 years of biostatistical experience in the clinical trials or health research environment.
- thorough knowledge of ich gcp guidelines and other applicable regulatory rules and guidelines and of medical terminology, clinical trials, and clinical research.
- working knowledge of the relationship and regulatory obligation of the cro industry with pharmaceutical/biotech companies.
**about our client**
join a team that works on groundbreaking compounds and profoundly impacts patients’ lives! they are serious about scientific integrity and has a dynamic company culture, including a focus on work-life balance.
**value proposition for you**
- flexible work schedule.
- proven potential for professional growth.
- a community of brilliant minds at your disposal.
- the stability of working for a robust, financially sound cro that is growing at a sustainable pace.
- exposure to more than 20 therapeutic areas, including cutting edge therapies such as immuno-oncology, biosimilars, gene therapy, and new molecular entities.
Note: please attach your latest cv along with your response on zintro.+34 Other Responses
Systemic Lupus Erythematosus
we are a prominent market research firm and an authorized zintro partner.
We would like to talk with european rheumatologists specializing in management of systemic lupus erythematosus (sle) patients. Ideal candidates should have a deep knowledge of current therapies used in the treatment of sle, including sle biologics (experience using benlysta and rituxan/mabthera is a must), and be familiar with some of the emerging sle therapies (e.G., subcutaneous belimumab, epratuzumab, blisibimod, atacicept, sifalimumab, etc.), that includes results of the published clinical trials for these emerging agents.
The candidates must practice medicine in france, germany, italy or spain and have a level of language proficiency for a 45- minute phone interview in english. Compensation will be provided.+6 Other Responses