clinical case manager

job summary: Clinical Study Operations & Vendor Management (HEOR / Oncology) 6 Months | $80-$90/hr w2 Remote | Contract We are seeking a Clinical Study Operations & Vendor Manager to support Epidemiology, HEOR, and Oncology research programs. This role will focus on Study Operations, Vendor and Contract Management, and budget tracking. MUST HAVE Direct Pharma/Biotech Industry Experience in an Operations RoleMust have functional understanding of Epidemiology, HEOR in order to effectively interact with HEOR or RWE vendorsPowerPoint & Excel for cost analysis and general project function Vendor and Contract Management experience   location: Telecommute job type: Contract salary: $80 - 90 per hour work hours: 9 to 5 education: Bachelors   responsibilities: As a key member of the Epi-C team, you will provide project management, financial oversight, and operational support to ensure the efficient execution of budgets, contracts, invoices, and administrative processes. This role requires strong organizational skills, attention to detail, and the ability to collaborate across functions and with external partners. Oversee project timelines, study tracking, and cross-functional/vendor meetings.Facilitate RFP processes, assisting with vendor selection and evaluation.Track departmental budgets, process invoices, and manage purchase orders.Reconcile accounts and oversee financial accruals and reporting.Negotiate and track vendor and HCP contracts, ensuring compliance.Support onboarding, rate-tiering, billing, and qualification processes.Serve as a point of contact for vendors and HCPs on administrative matters.Organize and support EPIC program meetings, including scheduling, documentation, and dashboard management.Maintain databases, records, and document management systems.Schedule and participate in meetings, handling note-taking and follow-ups.Support additional tasks as assigned.  qualifications: Required Advanced degree (preferred) with approximately 3 years of relevant experienceBachelor's degree with approximately 8 years of relevant experience. Preferred Experience of managing small and large-scale scientific projects, with knowledge of epidemiology, HEOR and patient centered outcomesGood interpersonal skills to be able to problem solve with multiple stakeholders and senior SMEsAbility to draft and execute consulting agreements with top SMEsAbility to organize and manage team meetings and workshops *LI-AT1   skills: Epidemiology, MS-Project, Health Economics 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.

job summary: PIPELINE POST APPLY FOR CONSIDERATION FOR FUTURE OPENINGS Global Case Management Specialist 6 Month Contract $50 per hour max (non-negotiable) Fully Remote MUST HAVE: BS Degree (healthcare related strongly preferred)Direct Pharma/Biotech experience preferredClinical Safety - end to end case processingStrong PV Case Management & Follow UpVaccines experience a plusArgus SUMMARY Reporting to the Sr. Manager, PV Operations Global Case Management, this role will be responsible for effective execution of the activities of triage, processing, and quality control of individual case safety reports (ICSR) from clinical trials to ensure timely and accurate assessment of adverse event reports. This role will focus on accurate case entry and writing a detailed narrative to describe adverse events reported in clinical trials. This is an exciting time to join as we experience acceleration in our pipeline and late phase development, thereby poising us for substantial growth in the upcoming years. The Specialist, Global Case Management will provide critical support to our future success in making a transformative impact to patients through our vaccines and therapeutics. This is an exciting opportunity to play an important and valued role as a member of the PV team at a high-growth organization that is radically changing the biotech industry and promoting global public health.   location: Cambridge, Massachusetts job type: Contract work hours: 9 to 5 education: Bachelors   responsibilities: Here's What You'll Do: Perform activities of triage of ICSRs as neededReview, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments.Use source documents received to write a comprehensive narrative describing the adverse event appropriately.Process safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and Company requirements.Operate on Electronic Data Capture to perform follow-up with clinical trial sites.Manage multiple tasks simultaneously and prioritize competing requests and or projectsAssist with individual projects assigned by global PV management in support of Clinical Safety and Pharmacovigilance departmental initiatives  qualifications: REQUIRED Bachelors/Associate degree preferably in life science, nursing, pharmacy or other healthcare related professional5 years of experience in drug safety/pharmacovigilance case processing experience for clinical trials within the pharmaceutical or biotech industryMedical Writing experience preferred (patient safety narratives)Argus safety database experienceMS Office suite, Excel, PowerPoint, Visio, electronic data capture (EDC) systems, and electronic document management systems Knowledge of GCPs, ICH guidelines, and FDA, EMA, and other international regulations and guidelinesFluency in English *Benefits offered include: medical/dental, life, disability, 401k, and more *LI-AT1   skills: Pharmacovigilance, Argus, Drug Safety, AD (Adverse Events), ICSR (Individual Case Study Report) 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: The Senior Clinical Safety Specialist manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology division. This position is responsible for authoring and ensuring execution of project-specific safety plans as well as overseeing event and complaint processing in accordance with study-specific operational plans.   location: Hopkins, Minnesota job type: Contract salary: $50.00 - 58.20 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Manage adverse event processing including report review, safety query management, and expedited reportingAssess type/level of processing to be done for adverse eventsAuthor study specific safety documents and plans (e.g.: safety plan, CEC / IMR Charter, etc.)Acting member of clinical core teamConduct Clinical Trial Safety Review meetingsEnsure adjudication and reconciliation of safety events are completed prior to data snapshotsProvide safety-related input to other study documents / processes as requested (e.g.: protocol, CRF design, etc.)Manage functional deliverables to ensure study milestones are not delayedManagement of additional projects, deliverables, and timelines to support additional activities within the clinical departmentIn all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.  qualifications: Required: Bachelor's degree (BS) or equivalent experience in science-related fieldMinimum 5 years clinical trial experience within role of safety requiredProven or prior experience with clinical trial safetyMedical device background Preferred: Therapeutic knowledge in UrologyKnowledge of GCPExperience with processing and assessing safety events and medical narrative writingClinical database and systems  skills: Quality control, CRF, GCP (Good Clinical Practice), AD (Adverse Events) 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.