clinical case manager

job summary: As the largest staffing and recruitment agency in the world, we can commit to finding 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!   location: Princeton, New Jersey job type: Contract salary: $75.00 - 83.87 per hour work hours: 9 to 5 education: Bachelors   responsibilities: The company is seeking a Quality Control and Administration Manager, Clinical Supplies Systems to perform quality control on documentation and financial-related administration. This person will be required to work with external IRT vendors (day-to-day operations and leadership capacity) to ensure the company's IRT systems align with internal stakeholders and timelines from business. This position will work collaboratively and cross-functionally to review documentation prior to upload to eTMF and work with external vendors on processing SOWs, COs, and Invoicing. The successful candidate is a subject matter expert at IRT-related finance, ability to review documentation with a keen eye, imaginative, skilled at understanding the needs of a clinical development operations organization with high attention to detail, a collaborative outlook, a positive leader, above no task, and the ability to pursue multiple options in parallel to meet project timelines 100% of the time. Ensure all operational documents are complete, accurate, and compliant with internal standards.Verify proper signatures and oversight are obtained at each step of the process.Process Statements of Work (SOWs), Change Orders (COs), and invoices with precisionMaintain a state of 100% financial reconciliation and ensure on-time processing of invoicesCollaborate with contracts and procurement teams to ensure timely processing of COs and SOWsAddress and resolve any discrepancies or delays in contract processingResponsible for administration and uploading documentation to appropriate eTMFPerform routine budget reconciliations to ensure financial accuracyPrepare and present detailed financial reports to the Director of IRTTask assignments may expand in scope based on the individual's level of experienceMay be asked to participate in internal audits or external inspections  qualifications: At least five to eight years of financial reporting experienceBachelor's degree in a science-based or financial-based subjectIRT Subject Matter ExpertiseCreative, capable problem-solverExperience in establishing and maintaining relationships with vendorsWorking knowledge of ICH, GAMP, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirementsDemonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePointSuccessful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas.Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes  skills: Quality control, MS-WORD, MS-EXCEL, MS-Powerpoint, Vendor Management, TMF, 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). This posting is open for thirty (30) days.

job summary: You are a part of Clinical Affairs orgabization. The Clinical Development Scientist reports to the Director of Clinical Affairs in the business.   location: Cambridge, Massachusetts job type: Contract salary: $80 - 106 per hour work hours: 8am to 5pm education: Masters   responsibilities: You are responsible for: - Leading the development of evidence generation strategies for assigned projects, working within a cross-functional team, in line with the value proposition that addresses the evidence needs of all key stakeholders - Delivery of Clinical Development Plans, describing the plans for clinical evaluation, as per internal and external requirements (US,EU, China, etc) - Working closely together with internal (project owners, regulatory, clinical study managers, statisticians, business leaders, etc.) and external (clinical consultants such as key opinion leaders and subject matter experts) stakeholders to ensure that studies yield well-founded conclusions. - Design and development of study protocols in compliance with project standards, specifications and applicable regulatory guidelines (GCP, ICH, FDA, ISO, EU MDR). Manage and oversee study execution, analysis of results and generation of final study reports to support Philips regulatory clearances, claims, epidemiology/surveillance, reimbursement, health economic outcomes and/or market access. - Deliver assigned clinical programs, working in partnership with Clinical Operations. - Lead the development and dissemination of evidence generated from clinical evaluation plans to deliver Clinical Evaluation Reports in accordance with EU and China requirements, Clinical Study Reports and Clinical Summaries, and manuscripts - Lead clinical evidence, epidemiology/surveillance discussions with regulators (deficiency requests/FDA, Notified Bodies, etc.), advisory boards, associations, and societies - Keeping current with regulatory guidance and requirements in the global environment. - Ensuring appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, etc. - Support Medical Safety function to help support signal detection, signal evaluation - Advance the Philips Data network strategy by developing innovative data partnerships - Support the creation of data infrastructure efficiency through creation of systematic processes including data dictionaries, including the evaluation of real-world data vendors, and data access and transfer models. - Support the Data Governance Council in leading understanding of deidentification and data use standards (including, data tokenization)   qualifications: Experience level: DirectorMinimum 7 years of experienceEducation: Masters  skills: Clinical Development Plans (5 years of experience is required)MD, PhD/MS Degreeclinical research/development (7 years of experience is required)Communication Machine Learning 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 Digital, 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 Digital 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.

Now Hiring: Clinical Licensure Coordinator Are you ready for a life-changing opportunity? Are you ready to learn and grow with a Top Fortune 500 company? Then embrace this rewarding opportunity NOW! Apply today because openings are limited!! Overview: The Licensure Coordinator is responsible for the end-to-end activities associated with new and renewing State issued clinical licenses across all clinical specialties (e.g. nurses, physicians, dietitians) for employees. Includes primary source verification along with initial application and renewal mailings, reviewing content for completeness, and loading into the department’s database.The Professional Licensure team will continue to support the enterprise with clinical licensure to maintain and track over 241,000 licenses and certifications, as well as assist clinicians with obtaining new state licensure as the business continues to require the licensure in order to take calls and provide services to customers.  salary: $21 - $21.75 per hourshift: Firstwork hours: 8 AM - 4 PMeducation: BachelorsResponsibilities Review clinician demographics entered into the user interface and approve for importing Populate and print new license applications Timely communication with clinicians regarding missing information and/or inconsistencies Preparing application(s) mailings Complete full quality assurance review of clinician application returned to department by clinician Obtain license payment funding on behalf of clinician Submit application including payment and other required supporting documents Follow-up on outstanding applications submitted to State board Monitor aging reports and take appropriate action with State board and/or clinician Perform online payment requests and manual check payment requests Perform primary source verification – accessing individual State board websites Special assignments including – monthly interaction audits; State board reporting Support special accreditation applications such as URAQ and JCAHO Onboard clinicians into clinical licensure system(s) Extensive work experience within own function Work is frequently completed without established procedures Works independently May act as a resource for others May coordinate others' activities Meeting business demands and deadlines in a frequently changing environment SkillsHealthcarehealth insuranceinsuranceclinical credentialinglicensuredetail orientationOrganizationQualificationsYears of experience: 1 yearExperience level: Entry LevelRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. 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.