clinical case manager

job summary: The Clinical Evaluations Specialist manages regulatory documentation for MDR remediation and PPRRs, requiring expertise in clinical literature reviews, regulatory writing, and post-market surveillance. This role supports medical device life cycle management and collaborates with cross-functional teams. Foreign-trained ophthalmologists are encouraged to apply. This is a 6-month on-site contract in Duluth, GA, with the potential for extension. #LI-AB1   location: Duluth, Georgia job type: Contract salary: $65.00 - 72.46 per hour work hours: 9 to 5 education: Masters   responsibilities: Regulatory Documentation & Clinical Evaluation: Author, revise, and update clinical documents for MDR remediation and PPRRs, conduct systematic literature reviews, appraise clinical data, and develop Clinical Evaluation Reports (CERs), PMCF Plans and Reports, and risk-benefit analyses to support regulatory submissions.Life Cycle Management & Risk Assessment: Serve as the clinical contact for Life Cycle Management (LCM) and PPLCM activities, providing clinical expertise and ensuring compliance with global regulatory requirements.Process Improvement & Compliance: Monitor regulatory changes (EU MDR, FDA, ISO 14155), enhance SOPs for clinical evaluations, and track quality metrics to ensure ongoing compliance and process improvements.  qualifications: Required: Master's in Vision Science, Ophthalmology, Biomedical Engineering, Biomedical Sciences or related degree.Experience with EU MDR, MEDDEV 2.7/1 Rev. 4, and FDA guidelines in the context of clinical evaluations and post-market surveillanceExperience authoring or contributing to Clinical Evaluation Reports, Post-Market Clinical Follow-up Reports, or Risk-Benefit Analyses Preferred: Foreign-trained ophthalmologistsExperience in ophthalmology or eye careExperience conducting systematic literature reviews and appraised clinical data to support regulatory submissionsRAC, AMWA, or EMWA certification(s) #LI-AB1   skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, 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). 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.

job summary: This individual will support the PK/PD aspects of clinical studies (from protocol to CSR) and related regulatory submission activities. This role requires a strong pharmacokinetics/pharmacodynamics/pharmacometrics knowledge. #LI-KH1   location: Telecommute job type: Contract salary: $175 - 208 per hour work hours: 9 to 5 education: Doctorate   responsibilities: Support PK/PD aspects of clinical studies, including synopsis/protocol development, statistical analysis plan and clinical pharmacology data analysis plan review, TLF shell and dry-run reviews, and CSR.Oversee relevant PK/PD data analyses: non-compartmental PK, population PK and PK/PD, and other modeling and simulation activities as needed.Contribute to regulatory documents including Investigator Brochures, Labeling and those required for regulatory meetings and regulatory filings.  qualifications: Required Ph.D. degree with at least 5 years of related experienceIf no Ph. D, would accept a MS degree with at least 10 years of related experienceEducational background in one of clinical pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, statistics or another related field.  skills: Pharmacology 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). 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.

job summary: As the world's largest staffing and recruitment agency, we are dedicated to helping you find the ideal role that offers growth and development opportunities within the life sciences sector. By working with a recruiter, you gain access to a vast network of leading employers and detailed insights into a wide range of positions. One of our premier partnerships is with a research-driven biopharmaceutical powerhouse focused on developing treatments for complex, hard-to-cure diseases. This esteemed company has brought 32 groundbreaking products to market, including Humira and Lupron, making a significant global impact. If you're ready to make your mark in the field and contribute to the future of innovative therapies, this is the opportunity for you!   location: Telecommute job type: Contract salary: $38.00 - 40.18 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Manage Phase I to IV study activities. Ensures the Master File is always inspection-ready and complies with ICH GCP guidelines. This role involves regularly updating and assisting study teams to address issues related to key Master File health indicators, including the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials. Ensures the Master File is always inspection-ready and complies with ICH GCP guidelines. This role involves regularly updating and assisting study teams to address issues related to key Master File health indicators, including the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials.   qualifications: Required Skills: Bachelor's degree or international equivalent (preferred but not mandatory).Minimum 2 years of relevant industry experience in clinical document management or equivalent.Strong analytical and critical thinking skills.Excellent oral and written communication skills.Ability to facilitate cross-functional team meetings.Awareness of clinical documentation business procedures.Compliance with clinical documentation processes. Preferred Skills: Experience with Microsoft PowerPoint and Excel.Familiarity with Document Management Systems.Understanding of ICH GCP guidelines and clinical trial documentation.  skills: Phase I, Phase II, Phase iii, Phase iv, GCP (Good Clinical Practice), ICH Regulations, TMF 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). 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.