clinical case manager

job summary: Provides clinical support for diagnostic product development to achieve clearances and approvals in the US and internationally. Provides clinical trial site management and assures successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures. Reviews, assesses and interprets data from ongoing and completed studies. Conducts clinical compliance activities. May be responsible for multiple clinical studies.   location: Telecommute job type: Contract salary: $66.75 - 83.50 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Responsible for the day to day management of clinical trial sites across multiple clinical projects.Identifies and builds relationships with external clinical sites.Manages multiple clinical trials in parallel including investigator selection, analysis of potential enrollment, preparation of trial related documentation (protocols, case report forms, consent documents, letters of agreement, confidentiality agreements, etc.) and organize investigator's start-up meetings.Works with business development to contract external sites, as required.Submits protocols and other documents to Institutional Review Boards / Ethics Committees with follow through to ensure successful outcome.Monitors the assigned clinical trials following company SOPs and in accordance with GCP and all FDA and applicable international regulations concerning clinical trial activities.Assists in preparation of study-specific binders, logs and forms.Plans the requirements for clinical trial material, orders clinical trial material, sets up and monitors the systems whereby the clinical project coordinator can ship clinical trial material to the investigator, maintains procedures to account for the clinical trial material, checks the expiration of clinical trial material and requests extensions if necessary.Manages enrollment strategies to meet study requirements (e.g., investigator and study coordinator meetings, newsletters, advertising, etc.).Coordinates shipment of clinical samples and the resulting data when central laboratory facilities are used.Tracks completed CRFs and sets up systems whereby completed CRFs are rapidly entered into the database. Ensures that queries generated during data cleaning are responded to in a timely fashion.Evaluates clinical data/information and prepares reports as required.Participates in conference calls and meetings to review progress of ongoing clinical trials.Reviews all UADEs, ensures appropriate approvals are obtained, that sites are notified and that all company procedures are complied with.Maintains project files including: ethics committee approvals; curricula vitae of investigators and study personnel; package insert and user guides; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.Participates in the conduct of internal and external audits and inspections of clinical studies. Participates in departmental planning sessions, and SOP development.Mentors junior CRAs to promote departmental skill base.Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.  qualifications: Education & Experience Bachelor's Degree in a life science, health-related field, or equivalent. A Master's Degree or PhD is highly preferred.Proven experience in clinical trial site management across multiple clinical projects, specifically within the diagnostic product development space.Demonstrated success in achieving US and international regulatory clearances and approvals for diagnostic products. Core Competencies & Skills Clinical Trial Lifecycle Management: Expertise in overseeing the entire clinical trial process, including investigator selection, enrollment analysis, and comprehensive trial documentation (protocols, CRFs, consent forms, letters of agreement). Ability to manage multiple clinical studies in parallel from start-up to completion.Site Relationship Building: Strong track record of identifying, engaging, and fostering relationships with external clinical sites. Experience working collaboratively with business development for site contracting.Regulatory & Compliance Acumen: In-depth knowledge and practical application of Good Clinical Practice (GCP), FDA regulations, and relevant international guidelines. Proficient in submitting protocols to IRBs/Ethics Committees and ensuring successful outcomes.Clinical Monitoring & Data Integrity: Skilled in monitoring assigned clinical trials to ensure adherence to SOPs and regulatory standards. Experience with tracking CRFs, managing data entry, and resolving data queries efficiently.Clinical Trial Material & Sample Management: Experience in planning, ordering, and managing clinical trial materials, including shipping, accountability, and expiration date tracking. Competence in coordinating the shipment of clinical samples and associated data to central laboratories.Enrollment Strategy Development: Ability to design and implement effective enrollment strategies to meet study timelines and objectives.Reporting & Analysis: Capable of evaluating clinical data, interpreting findings, and preparing comprehensive reports. Active participation in project review meetings and conference calls.Safety Reporting & Documentation: Experience with reviewing and managing Unanticipated Adverse Device Effects (UADEs), ensuring proper approvals, site notifications, and procedural compliance. Meticulous in maintaining comprehensive project files for regulatory and audit readiness.Quality Assurance & Mentorship: Participation in internal and external audits/inspections of clinical studies. Willingness to contribute to departmental planning and SOP development, and a desire to mentor junior Clinical Research Associates (CRAs). #LI-CV1   skills: CRF, Clinical research, GCP (Good Clinical Practice), COV (Close-Out Visit), CTMS (Clinical Trial Management Systems), EDC (Electronic Data Capture), PSV (Pre-Study Visit), RMV (Routine Monitoring Visit), SIV (Site Initiation Visit), TR (Trip Report), 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: 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.