clinical case manager

job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!   location: North Chicago, Illinois job type: Contract salary: $40.00 - 44.26 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. Attends congress and reviews literature to develop and augment expertise in therapeutic areaHelp develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and help identify and evaluate business development opportunities.Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to program. Engage opinion leader interactions to build pipeline awareness and foster research collaborations.Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and may participate in meetings.  qualifications: Bachelor's degree in the sciences; advanced degree (e.g., MS, PhD) preferred.Ability to provide input and direction to clinical research with appropriate supervisionStrong desire to collaborate in a cross-functional setting.Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols  skills: MS-WORD, MS-EXCEL, CTMS (Clinical Trial Management Systems) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!   location: Lake Forest, Illinois job type: Contract salary: $40.00 - 44.67 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines.Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary.  qualifications: College degree with 3-7 years of clinical research experience (could be within pharma or at a University of Medical Institution.  skills: Phase I, Phase II, Phase iii, Phase iv, GCP (Good Clinical Practice), CTMS, Portfolio Management, Study Planning, CTMS (Clinical Trial Management Systems), ICH Regulations Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: Senior Manager, Site Contracts and Budgets is responsible for program and/or clinical trial-level management and oversight of site contract and budget negotiation and execution for Phase I-IV clinical trials at Client. The Sr. Manager will collaborate closely with key CDO functional stakeholders, including CSMM, Clinical Trial Excellence and Support (CTES) and Clinical Operations in the development and ongoing oversight of site contracts and budgets execution during the clinical trial start up (SSU) phase to support site activation as per target timelines. Here's What You'll Do: Responsible for direct oversight and management of site contracts and budgets for multiple assigned clinical trials within designated therapeutic area. Provide consistent site contract/budgets oversight and support to assigned Clinical Operations clinical trial teams, offering up-front and ongoing strategic planning specific to the program and needs of individual studies. Leverage use of internal and CRO provided Investigator Grants (IG) reference data and available Fair Market Value (FMV) benchmarking tools to establish clinical trial-specific IG budget estimates for trial budget forecasting needs. Lead and/or contribute to development of target FMV-based IG budget and negotiation parameters according to therapeutic area (infectious disease, oncology and/or therapeutics) in an outsourced CRO model. Act as lead point of contact (POC) for CRO site contracts and budgets-related activities for assigned studies; oversee the development and approval of global investigator site budgets and associated negotiation parameters. Ensure cross-program/cross-clinical trial consistency in country-level site budget targets and parameters. Responsible for direct management and tracking of CRO investigator site CTA/budget negotiations in alignment with FMV and GCP-driven principles. Collaborate with assigned CRO and Clinical Operations in ensuring that established clinical trial IG budget remains within target during CTA negotiations process Serve as liaison between CRO and Client Legal/Clinical Contracts and Outsourcing teams in the review and finalization of country-level CTAs/CSA templates. Monitor KPIs, including cycle times and SIV/site activation targets, to ensure adherence to baseline clinical trial timelines for CTA negotiation and site activation. Attend Clinical Trial Team (CTT) and/or joint Client/CRO clinical trial team meetings on an agenda-driven basis, i.e. when strategic decisions that impact site contracts are being discussed. Act as lead POC for required site contract and/or budget amendments throughout the duration of assigned studies. Proactively identifies site contract-related risks and potential roadblocks. Escalates issues proactively to Sr. Director, CSMM and/or Clinical Operations teams to prevent delays in site activation timelines. Here's What You'll Bring to the Table: Minimum 5 years' direct experience in global investigator site budget negotiations; preferable experience in CTA template language negotiations and/or support in collaboration with Legal. Effective communication and collaboration with key internal and external stakeholders, including CDO, CRO and investigator site personnel. Familiarity in working within an outsourced model; experience in direct CRO oversight of CTA/budget negotiations. strong experience in use of various site contract and budget management systems, processes, and computer software (e.g., Grants Manager, Grant Plan) Proficient in MS Office Products with advanced knowledge of Excel; ability to work with and be proficient in stand-alone system applications. High level of attention to detail in management of high volumes of investigator site financial data. Works on increasingly complex and problems of diverse scope requiring critical analysis and comprehensive evaluation of critical factors. Increasingly exercising independent judgment in developing methods and techniques to obtain solutions (and process improvements). Increasing independence in determining specific tasks to accomplish in order to meet certain goals and objectives. Increasing self-reliance in performing tasks. Works in a team environment.  location: NORWOOD, Massachusetts job type: Contract salary: $60 - 104 per hour work hours: 8am to 4pm education: Bachelors   responsibilities: Familiarity in working within an outsourced model; experience in direct CRO oversight of CTA/budget negotiations. strong experience in use of various site contract and budget management systems, processes, and computer software (e.g., Grants Manager, Grant Plan) Proficient in MS Office Products with advanced knowledge of Excel; ability to work with and be proficient in stand-alone system applications. High level of attention to detail in management of high volumes of investigator site financial data. Works on increasingly complex and problems of diverse scope requiring critical analysis and comprehensive evaluation of critical factors.   qualifications: Experience level: ExperiencedMinimum 5 years of experienceEducation: Bachelors  skills: Manager Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.