Clinical Data Management Billing Rates
i am in need of billing rates for job roles in clinical data management, medical writing and biostatistics for the following countries:
i would require the information by 5th feb 2016 (ist timing) as this is a quick request.
Thank you+19 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 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
Oncology Clinical Research Associate
The clinical research associate completes project activities associated with monitoring functions of phase i-iv clinical research studies. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (sops).
-knowledge of applicable sops, guidelines and study procedures.
-assist with protocol and crf review.
-develop informed consent forms.
-conduct study feasibility and site selection activities.
-assist with the development of study manuals, annotated crfs, monitoring conventions, tracking forms, site study tools, and other study materials.
-develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
-assist with investigator meeting activities including organization, preparation and attendance.
-conduct site management activities, including but not limited to site qualification visits, site initiation visits, site training, site interim monitoring visits, and site close out visits.
-perform co-monitoring visits and performance assessment visits, when properly trained and delegated by clinical research manager
-ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
-establish and maintain good rapport with study sites.
-write study visit reports and follow up letters within the timeline established by applicable sops and guidelines
-coordinate timely shipment of clinical supplies and study drug to sites.
-ensure proper storage, dispensation and accountability of clinical supplies and study drug.
-maintain adequate site tracking records.
-follow up of drug safety issues and safety reports in timely manner, if applicable.
-communicate site study issues, concerns, and progress to clinical research manager, project manager and clinical team lead accordingly.
-assist with data query form (incl. Query process).
-perform telephone monitoring activities in order to obtain study status information.
-development and implementation of corrective actions when appropriate.
-prepare/review all patient tracking records.
-input and maintain study information concerning subject status of financial reimbursement to sites.
-mentor for site manager and/or site manager ii, when assigned
-conduct on the job training and formal training to other site managers.
-collaborate with clinical research manager/ study teams to resolve site issues
-review study visit reports, follow-up letters and site communication generated by other site managers for timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from clinical team lead or clinical research manager as needed.
-bachelor’s degree, preferably in allied health fields: medical, nursing, pharmacy, psychology, veterinary or health science.
-minimum of 4 years of clinical research experience; preferably in clinical research monitoring of international, multi-center clinical trials in multiple therapeutic areas.+19 Other Responses