clinical case manager

job summary: Join a dynamic, fast-paced oncology development team as a Clinical Data Manager supporting first-in-human trials through clinical proof of concept. This hybrid role (four days onsite) offers the opportunity to work hands-on with cutting-edge early development studies while collaborating with cross-functional experts in clinical data integrity, analysis, and technology. You'll be based at a state-of-the-art research site in Grayslake, IL-an environment built for innovation and scientific excellence. Ideal for professionals with 4+ years of experience in pharma or clinical research, this position offers meaningful ownership of data oversight and a key role in ensuring the success of breakthrough clinical trials.   location: Grayslake, Illinois job type: Contract salary: $45.00 - 50.48 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Provide CRO oversight and feedback related to data management operations, issue trends, and performance Support operational objectives and study deliverables for assigned Oncology Early Development (OED) studies Utilize EDC platforms, reporting, and visualization tools effectively Review CRO deliverables to ensure adherence to data standards and protocol requirements Evaluate study execution documents, including specifications, data management plans, data review plans, and data transfer plans Oversee CRO performance in tasks such as: Third-party vendor data reconciliation Medical coding processing Protocol deviation collection Query management Identify and triage clinical data issues as they occur Ensure data quality and integrity by resolving errors and inconsistencies in clinical data Confirm CRO adherence to federal/local regulations, GCPs, ICH Guidelines, and internal data management standards Collaborate with internal stakeholders, including OED Statistical Programming and Data Management teams  qualifications: Required Skills: Minimum 4+ years of experience in pharmaceutical, clinical research, data management, healthcare, or a related field Strong understanding of clinical trial processes and clinical data lifecycle Deep knowledge of Good Clinical Data Management Practices (GCDMP) Demonstrated ability to manage multiple priorities in a fast-paced, deadline-driven environment Proficient in using Electronic Data Capture (EDC) platforms and clinical data systems Experience reviewing and contributing to study documents such as data management plans, data review plans, and data transfer plans Strong understanding of data standards and protocol-driven data design Proven track record of effective problem-solving and analytical thinking Clear and professional written and verbal communication skills Experience with CRO oversight and vendor management Familiarity with regulatory requirements including GCP, ICH guidelines, and FDA regulations Must be willing to work hybrid (4 days onsite) at the Grayslake, IL location Must be local to Illinois or able to reliably commute Must be authorized to work in the U.S. without sponsorship Preferred Skills: Experience in oncology clinical trials, especially early-phase/first-in-human studies Hands-on experience with reporting and visualization tools for clinical data Familiarity with coding processes (e.g., MedDRA, WHODrug) and protocol deviation tracking Bachelor's degree in life sciences, management information systems, computer science, or a related discipline Exposure to cross-functional collaboration with biostatistics and statistical programming teams #LI-ST1   skills: Data Analysis, Clinical Data Management, GCP (Good Clinical Practice), 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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.

job summary: Please note: This is a pipeline role and not an active opening. We are proactively identifying candidates for a potential part-time Clinical Research Associate (CRA) position supporting global Phase II/III oncology trials. Responsibilities may include site communication, vendor oversight, document management, TMF review, and data quality monitoring. Ideal candidates will have 3+ years of clinical research experience, strong GCP/ICH knowledge, and the ability to work effectively in fast-paced, collaborative environments.   location: Menlo Park, California job type: Contract salary: $80 - 95 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Support Phase III trials through site management, document oversight, and CRO/vendor coordinationEnsure compliance with GCP, ICH, and regulatory requirements across study activities and documentationMaintain TMF completeness, oversee data quality, and collaborate with cross-functional teams for successful trial execution  qualifications: Required: 3+ years of experience as a CRA, including Phase II/III trialsStrong understanding of ICH/GCP guidelines, drug development, and patient recruitment strategies Preferred: Experience in oncology and/or rare disease trialsWorking with CROs and global teams #LI-AB1   skills: Clinical research, Vendor Management, 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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

job summary: The Manager, Clinical Systems (IRT) will work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Study Management, Supply Chain and Data Management functions) and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial. The Manager, Clinical Systems (IRT) will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.   location: Telecommute job type: Contract salary: $75.00 - 83.87 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Serve as the champion and consultant for most efficient and effective IRT design as needed per study protocol Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts Design and oversee the development of study-specific IRT technical documents Document issues and risks, and implement mitigation plans in partnership with study team and technology supplier PM Identify and track study-related technical issues to resolution Closely manage project-related timelines and associated activities   qualifications: Required: Doctorate Degree or Master Degree and 2 years of IRT experience or Bachelor Degree and 4-5 years IRT experience, clinical experience OR Associate's degree and 10 years of IRT experience OR High school diploma/GED and 12 years of IRT experience Preferred: 5+ years focused on IRT experienceBachelor's Degree in life science, computer science, engineering, business or related discipline4+ years of experience in clinical operations, clinical supply chain or clinical systems managementExperience implementing clinical systems, such as IRT and eCOAWorking knowledge of Good Clinical Practices and FDA regulations governing clinical trial executionDetail-oriented and able to manage many projects simultaneouslyExcellent documentation and communication skillsMeeting management and facilitation skillsVendor management experienceExcellent time management and organization skills in a timeline-driven environmentSound problem resolution, judgment, and decision-making abilitiesWork well in a team-based environment with minimal supervision #LI-CV1   skills: FDA, Clinical Data Management, GCP (Good Clinical Practice), Clinical Study Design 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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.