clinical case manager

job summary: The Director, Clinical Trial PV Operations will provide functional expertise and Program level oversight of outsourced PV Activities globally, including set up and conduct of clinical studies from a PV perspective, CRO training and management.Partners with key stakeholders within and outside PV to ensure continuous harmonized operations of global Pharmacovigilance activities and maintain highest standards for integrated functioning.Responsible for overall leadership to support global principles and standard practices for PV operational activities within clinical trials.Identify potential cross TA issues/risks in a proactive matter and lead discussions to mitigate themBe proactive in identifying any process gaps across TA and propose well thought out solutions and drive those solutions to implementations   location: Cambridge, Massachusetts job type: Contract salary: $100 - 150 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Oversee outsourced PV Activities supporting clinical Trials at the clinical program levelPerform oversight tasks of daily study specific activities including SAE reconciliation, study set up, query management, SAE reconciliation, eTMF filing etc..Support study specific Inspection and Audit requestsBuild and foster cross functional relationships to promote and support PSPV standardsInfluence others and work collaboratively across functions to align on best practices and processesConduct sample quality review of outsourced activities including SAE Reconciliation, eTMF filling, SAE Forms and completion instructions, protocol safety section etc..Review Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation PlansMaintain direct contact with the study PV Operations Lead at the vendor to proactively identify risks and issuesSupport Study/program specific Audits and Inspections related to PV OperationsMaintain knowledge of PV Regulations and global industry practices for PV operational efficiency and complianceLiaise with and advise study teams including clinical Science, Data Management, Regulatory Affairs and other functional areas locally/globally on matters relating to Pharmacovigilance to ensure overall compliance and appropriate standards and methodologies within the companyEnsure consistency in collection, processing and evaluation of safety data, to drive improvements in company global processes.Represent Pharmacovigilance Operations on global Program/study teams  qualifications: Bachelor's required. Degree in scientific/medical field or advanced degree preferred.previous experience working in global environment preferred.Minimum 10 years' experience in PharmacovigilanceMinimum 7 years' experience working with CROs, vendors, and relationship management preferred.Demonstrated skills in negotiation and consensus decision makingExpert knowledge of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements.Good cross-cultural understanding and experienceCritical thinking and analytical skills and ability to make high level decisions in cross- functional and global environments.Ability to review, analyze, interpret and present complex data to a high standardUnderstanding of and contribution to company business needs and global strategyAble to interact with personnel from all functional areas and externally to the company at all levels and to represent the department and company in a highly professional manner.Good level of computer literacy with Microsoft applicationsExcellent organization skills and ability to prioritize individual and departmental workloads.Multi-tasking with the ability to successfully manage multiple critical issues simultaneouslyTake the initiative to patriciate in projects outside the direct remit of the job to enhance visibility of the department and ensure cross functional awareness of PSPV processes and standards. Some travel to global sites may be required.   skills: Project Management, Pharmacovigilance, Drug Safety, CRO Oversight, Electronic Trial Master File (eTMF), Serious Adverse Event (SAE) Reporting 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: 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: North Chicago, Illinois job type: Contract salary: $45.00 - 51.86 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Responsible for the project management of key Clinical Supply Chain activities at the protocol level for and Phase I - IV clinical trialsIncludes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol.Develops protocol specific labeling compliant with applicable global regulations.Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones.Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages.  qualifications: Education Requirement: Bachelor's Degree required preferably in physical/biological science, math, engineering or pharmacy. Experience: 2+ years total experience in the Pharmaceutical Industry. Preferably experience in one of the following areas:Drug discovery (eg, Process Chemistry, Analytical Chemistry)Drug development (eg, Formulation)Clinical operations (eg, Clinical Project Management)Supply chain (eg, Clinical Supplies Project Management)Quality Assurance Critical Success Factors Understanding of clinical development and global supply chain requirements.Competent in the application of standard business requirements (for example SOPs, Global Regulations).Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work.Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner.Ability to work effectively and professionally with those in the dept as well as Clinical, QA, Analytical and any area interface.Ability to manage and prioritize multiple tasks.Project Management skills.Good communication skills (both written and oral).   skills: Project Management, Phase I, Phase II, Phase iii, Phase iv, MS-Project, Quality Assurance (QA), Clinical Supply Chain Risk Mitigation 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.

Market leading healthcare organization looking for a Licensed Social Worker to join our team as a member of the Interdisciplinary Team! This is a hybrid role traveling in the field in the greater Gloucester, Lynn, Lowell and Methuen, MA area! Very competitive salary, robust benefit plan, and quality of life working M-F 8 hour day shift! Great Life work Balance position with excellent benefits! The Social Worker participates in the planning, implementation and evaluation of care plans that meet the objectives, standards and policies of the model of care. The social worker demonstrates proficiency in providing traditional social work services in a professional and respectful manner with the goal of helping older adults live safely and comfortably in their homes and communities for as long as they can. This position is full time M-F 8am to 4pm. Mandarin speaking required. We offer student loan repayments! RESPONSIBILTIES: Participates on the IDT's initial assessments, care planning and on-going re-assessments of participant care.Attends IDT meetings; actively participates in team meetings by sharing pertinent information, providing follow up to assigned tasks and helps to develop participant's plan of care.Completes all assigned assessments - (initial, semi-annual, annual, service request and/or significant event).Assesses the psychosocial needs of the participant and provides supportive counseling, working collaboratively with behavioral health providers.Facilitates hospital, rehabilitation and nursing home (NH) admissions and discharges as determined by the Interdisciplinary Team. Ensures that PASRR documentation is completed for NH admission.Assists in the conversion process of the participant from community to long-term care. Works collaboratively with Medicaid Specialist, skilled nursing facility, and participant's caregiver to complete conversion.Arranges and facilitates family meetings, as needed.Refers participants and families to appropriate community services and acts as liaison and/or advocate with community organizations for participants.Maintains professional, accurate and timely social service documentation in the participants' medical records.Conducts participant council meetings as assigned.Works collaboratively with Director of Social Work and Behavioral Health provider to ensure guardianship is up to date. Educates participant regarding health care proxy (HCP). Assists participant in completion of HCP form.Works collaboratively with fiscal department to maintain participant insurance benefits and completes required documentation of fiscal information in the medical record.Reviews plan of care with participants, guardian, and/or activated health care proxy as assigned.Complete authorizations for home care and other approved services timely and accurately.Completes home and/or skilled nursing facility visits to assess participant as indicated.Works collaboratively with Palliative care team; Assists with end of life planning as indicated.Provides timely communication to appropriate staff regarding the following: (disenrollment, conversion to long term care, transfer of sites, participant and/or caregiver demographic changes).Reports allegations of abuse to appropriate state agency; provides support and resources to participant as he/she will accept; completes required documentation.Ability to pass a fit test. Position requires mask where seal is critical.Performs other duties as required.Frequent local travel. Qualifications: Current Social Work licensure in the Commonwealth of Massachusetts at the Masters level (L.I.C.S.W. or L.C.S.W.) requiredMinimum of 1 experience in Social Work providing traditional Clinical or Case Management services with a geriatric populationCurrent C. P. R. Certification or ability to become certifiedTreat all participants in a welcoming and professional manner.Strong verbal, written and listening skills with ability to multi-task in a fast pace environmentall MSW eligible candidates to apply.Covid vaccinated Preferred. Benefits: Health insuranceDental insuranceVision insurancePaid time offRetirement planSupplemental benefits 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.