clinical case manager salaries in new york, new york

job summary: Position will primarily support Scientific Laboratory Services (SLS) Quality Assurance activities at all locations. The colleague in this role will participate in the following: ? Ensure SLS quality systems are maintained consistent with cGMPs, company policies, site procedures and regulatory guidance. The quality systems to be maintained include, but not limited to, laboratory investigations, instrument/facility qualifications, analytical method validation and transfers, deviation management, notification to management, corrective and preventive actions (CAPAs), site quality review team (SQRT) and change management. ? Ensure testing/administration is conducted in a manner consistent with cGMPs, company policies, site procedures and regulatory guidance. This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Parsippany, New Jersey job type: Contract salary: $37.83 - 45.14 per hour work hours: 9 to 5 education: Bachelors   responsibilities: ? Review/approve various types of laboratory documentation ensuring that strong scientific justification, adequate impact assessments and appropriate definition of root cause and corrective actions are identified. These documents would include (but not limited to) stability study change control, equipment change control, corrective and preventive actions, quality notification reports, testing notes, instrument/facility qualifications, analytical method validation and transfers and laboratory investigation reports. ? Ensure site quality systems are consistent with cGMPs, company policies, site procedures and regulatory guidance. ? Able to interpret quality requirements, both internal and external, and apply them to real life situations in the pharmaceutical industry. ? Experience with the principles and application of quality risk management. ? Work together with the SLS management to assure that objectives and metrics are met. ? Contribute to quality assurance management team initiatives and objectives. ? Create, track and approve corrective/preventive action items to help ensure they are completed within the agreed timeframes. ? Ensure testing/administration are conducted in a manner consistent with cGMPs, company policies, site procedures and regulatory guidance.   qualifications: Education: Bachelor's degree or higher in Chemistry/Biology or related discipline. ? Experience: 2-5 Years of related analytical chemistry/microbiology experience with a Bachelor's degree or 2-5 years working in a Quality Assurance position in the pharmaceutical industry. This experience should include authoring/approving analytical investigations and deviations. ? Experience with electronic laboratory support systems (gQTS, gLIMS, PDOCS) preferred. ? Experience with Human Performance and Risk Management principles is highly desirable. ? QC/QA experience in a drug product or API manufacturing environment is desirable. ? Excellent written and oral communication skills with the ability to summarize complex situations in an easily understandable narrative. ? Must be comfortable interacting with all levels of management in the organization.   skills: Quality control, Quality Assurance, Biology, Chemistry, Microbiology 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: The Evidence Generation Platform - Real World Evidence team is a rapidly expanding group that provides integrated, end-to-end RWE optimization, education, communication, and maximization of data partnerships' value within therapeutic areas (TAs) to meet both core and innovative Development, Regulatory and Commercial needs to support breakthroughs to change patients' lives. The Vaccines/Hospital TA is responsible for creating one of the greatest health advancements of all time, resulting in control, near-elimination or elimination of infectious diseases that were once pervasive. Cross-functional pipeline and asset teams create and deliver vaccines for high impact infections such as COVID-19, pneumococcal disease, and meningitis, hospital acquired infections, maternal immunizations and exploratory anti-cancer vaccines. Within the Evidence Generation Platform team, a dedicated team of RWE Scientists reporting to the Vaccines/Hospital RWE Team Lead will support the TA and other special projects. Leveraging their understanding of how RWE can support the entire lifecycle from molecule to marketplace, the RWE Scientist Consultant will deliver timely real-world insights (RWI) and RWE in collaboration with cross-functional teams, provide guidance on appropriate sources of real-world data and methods for meeting request objectives. Where external data sources or services are required, they will help consult for any external RWE studies. For both approaches, the RWE Scientist Consultant will ensure the development and application of consistent business rules and standards, versioning rules as care pathways evolve. The RWE Scientist Consultant will play a key role in delivering RWE projects and support the Vaccines/Hospital RWE strategy in alignment with the TA needs.   location: New York, New York job type: Contract salary: $51.88 - 69.58 per hour work hours: 9 to 5 education: Doctorate   responsibilities: Build strong internal and external partnerships by providing expert consultations on all aspects of RWD studies and analyses, including feasibility assessment, data source identification, protocol development, statistical analyses, and table shells.Contributes to RWI for feasibility assessments and go/no-go decisions.Generate RWE through collaborations with the pipeline / asset teams (eg, Early Clinical Development pipeline teams, Global Product Development franchise / asset teams, BU Medical affairs, HEOR, Commercial and other functions), RWE Biostatistics and other functions.Conduct and oversee execution of rapid RWD-based queries and studies and effectively communicate the findings using tables, visualizations, short reports and slide decks.Coordinates and drives cross-functional projects with RWE Biostatistics and other colleagues to create high quality RWE from rigorously designed protocols.Collaboratively develop high quality methods, approaches, protocols and designsSupport the development of RWD and analytics capabilities and utilization, and lead in applying cutting-edge advanced analytics methodologies, analysis tools, automation technologies, and visualization platforms to generate novel insights and actions.Define standards and processes to manage quality, consistency, usability, security, and availability of data throughout the data lifecycle; stay up-to-date on RWD/E best practices.Proactively identify opportunities to automate and create efficiencies, harmonize rules with other analysis teams, and load all deliverables into the Digital RWD knowledge and insights management system.Contribute to vendor due diligence for potential partnerships or new sources of data / technology as directed.Document all requests and track progress toward project completion, create and measure quarterly ROI metrics, and ensure support to business goals.  qualifications: SKILLS: Hands-on experience analyzing multiple types of real-world data, including EHR, open and closed claims, registry data, patient-reported data, laboratory tests and results, and microbiology testing data or other real-world data sources.At least 5 years of hands-on experience of query and analytic languages and technologies (e.g., SQL, R, SAS, IHD) (preferred) and of relevant biological and medical data standards (e.g. ICD, CPT, SNOMED) with experience with data analysis, data ingestion and data visualizationProven successful track record of scientific analysis of real-world data for scientific, business, quality, or other purposes.Ability to critically evaluate analytic results against the literature, subject matter expert feedback or other reliable sources to ensure biological and medical credibility in alignment with cross-functional team strategy / priorities.At least 5 years of experience in communicating in verbal and written form with all levels of personnel with diverse backgrounds, and able to create and deliver clear presentations to teams.Experience with protocol development and execution for non-interventional studies using a variety of analytical techniques and methodologies applied to various databases.Ability to rapidly learn new domains to understand the latest scientific or medical findings and incorporate them into projects as appropriate; to interpret data dictionaries and other technical documentation.Experience working under pressure with a high level of autonomy and internal motivation and adapting rapidly within evolving digital environment, with an emphasis on quality.Well organized with the ability to handle multiple projects and other tasks, and to prioritize, knowing when to escalate issues before they become major problems.Knowledge of vaccines development, infectious disease, host/pathogen interactions, immunology, clinicogenomcs, GWAS / PheGWAS dataset interpretation, and other Vaccines-relevant experience highly desiredAbility to communicate effectively with cross-functional teams and work in a highly matrixed environment, with demonstrated excellence in teamwork and collaboration highly desired.Skills developed in areas such as data ingestion, data visualization and tools (e.g., Tableau, Spotfire, etc.), and exploratory data analysis preferred. EDUCATION AND EXPERIENCE: Required: MPH in Epidemiology or Biostatistics with 5-10 years of experience in the pharmaceutical industry/consulting or PhD in Epidemiology with 2-5 years of experience in the pharmaceutical industry/consultingIdeal candidate will have experience in RWE analytics or NIS consulting, Nursing or Biomedical Informatics, Public Health, HEOR, Statistics, Epidemiology, Other Biological / Computational Science fields with a substantial quantitative and computational component, other related fields or commensurate professional experience. Hard Skills: Hands-on experience analyzing multiple types of real-world data, including EHR, open and closed claims, registry data, patient-reported data, laboratory tests and results, and microbiology testing data or other real-world data sources.Build strong internal and external partnerships by providing expert consultations on all aspects of RWD studies and analyses, including feasibility assessment, data source identification, protocol development, statistical analyses, and table shellsGenerate RWE through collaborations with the pipeline / asset teams (eg, Early Clinical Development pipeline teams, Global Product Development franchise / asset teams, BU Medical affairs, HEOR, Commercial and other functions), RWE Biostatistics and other functions .At least 5 years of hands-on experience of query and analytic languages and technologies (e.g., SQL, R, SAS, IHD) (preferred) and of relevant biological and medical data standards (e.g. ICD, CPT, SNOMED) with experience with data analysis, data ingestion and data visualization. Soft Skills: Effective communication with different cross functional teamsHighly collaborativeAbility to multitask, multiple projects at a time.Ability to Prioritize.  skills: Data Analysis, R Language, Biostatistical Analysis 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 find 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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Millburn, New Jersey job type: Contract salary: $65 - 84 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Reporting to the Site Quality Head, the AAA Site Remediation Lead is responsible for executing remediation project plans at the site, ensuring successful completion of remediation commitments and successful inspection outcomes. This role is also responsible for coordinating the site's routine remediation tactical meetings, reporting status and risk, and driving resource management, fulfilling Quality and Tech Ops remediation commitments and initiatives. This is a high visibility and demanding role, bringing with it the opportunity to learn about the company, shape global healthcare trends and have impact at the highest level. Responsibilities include but not are limited to: Right-hand person for the AAA Site Quality Head with respect to the site's Remediation PlanExecute, monitor, and control Site Remediation Project Plan for overall strategic implementation of deliverables within the site's commitments to Health Authorities.Manage a site-based team of resources responsible for the execution of remediation tasks relevant to the site's remediation objectives.Work in close collaboration with the site's Tech Ops and Quality associates, as well as AAA RLT Global Remediation Task Force Lead, AAA RLT Global Remediation Project Manager, and AAA global technical functions (i.e. Global Engineering, Global QC, Global Sterility Assurance) to harmonize remediation strategy and outcomes across the RLT platform.Responsible for routine reporting of the site based Remediation Plan status to appropriate stakeholders and delivering relevant content to Global Remediation Task Force and/or Remediation Steering Committee meetings, on behalf of the Site Quality Head.Drive the site's Inspection Readiness program for regulatory inspections, internal audits and providing hands-on support at sites in preparing for inspections / auditsDefine and plan agendas, deliver content and/or lead preparation for key site-based remediation management engagements and governance meetings including, but not limited to, Site Remediation Tactical Meetings, project governance meetings, and other core Strategy team meetings.Leverage project tools and templates to ensure streamlined project management across the network and adherence to strategic remediation communications plan.Support Site Quality Head and Site Head with budget planning and maintenance by ensuring the most up to date project information is available. Responsible for monitoring and controlling remediation spend at the site.Identify and mitigate projects risks, including timely escalation to Local and Corporate management.Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture. Helps build and drive a culture of compliance throughout the organization.Inspire change management initiatives and embed collaboration forums across the sites and as required with stakeholders. Control project scope to limit schedule changes and to capture changes of scope that may arise.Partner with Procurement to ensure smooth sourcing and delivery of services and/or assets required for remediation activities across the network.Perform provisional and final project handover, including Remediation Continuity Plan as needed  qualifications: Key performance indicators: Successful execution of Site Remediation Plan, meeting strategic objectives of AAA Global Remediation Task Force.Successful Health Authority Inspections Minimize business continuity risks.Feedback from internal and external partners. Background: Graduate in Chemistry, Pharmacy, Microbiology or another related scienceMinimum of 3 years Project Management experience. Recognized formal project management qualification (PMP/APMP/Prince2/P30 or equivalent) desirable.Minimum of 3 years of experience in quality-based roles including experience in GMP and/or laboratory operations requiredStrong project management capabilities with demonstrated ability to problem solve and mediate complex issuesStrong understanding and operating awareness of working in a pharmaceutical company. Experience in regulatory agency and partner/collaborator inspections is preferred.Good understanding of local/National Health Authorities regulations and company standardsStrong communication, leadership and team working skillsDemonstrated negotiation and conflict resolution skills both internal and external (cross network relationships)Highly motivated, driven and have a passion to be part of a fast-paced teamEffective in prioritizing, shows the appropriate sense of urgency around given tasks and driven to grow a businessCreative thinker in ways in which we can ensure better compliance and systems (A risk-based approach to Quality and Compliance)Strong analytical skills, problem solving ability and presentation requiredDemonstrated excellence in written and verbal communication. Ability to effectively communicate at all levels in the organization - oral and writtenDemonstrated ability to work cross-functionallyFlexibility and ability to prioritize and manage multiple tasks simultaneouslyLanguages: English fluently, verbally and in writing. Native language to where the site is based is favorable  skills: Project Management, Quality control, Laboratory Information Management Systems (LIMS), GMP (Good Manufacturing Practice) 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.