clinical case manager

job summary: We have two openings for a Sr. Clinical Date Team Lead - one full time and one part time (20 hrs./ week). These contract roles, supporting West coast hours, imvolve leading complex clinical studies, mentoring teams, and serving as the primary clinical liason.   location: Telecommute job type: Contract salary: $52.20 - 58.00 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.Acts as an interdepartmental and client liaison for all DM study activities.Produces project-specific status reports for management, Project Lead and/or clients on a regular basis.Monitors and analyzes study metrics and escalates per the organization's risk management processes.May participate in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required.Assists with project forecasting of hours and identification of resource requirements.Assists with the oversight of project budgets including identification of potential out of scope work and participation in the Contract Modification process.Leads, high volume/highly complex studies.Independently leads and delegates tasks to ensure timely completion of project activities to project, quality and budget.Mentors junior level staff on all associated tasks within a study.Assists with administrative and financial oversight for allocated projects.Communicates with management regarding all data management activities within their studies.  qualifications: Bachelor's degree (BS) or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Knowledge, Skills and Abilities: Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectationsAbility to use interactive computer programs good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detailAbility to work productively in both a team environment and independently as neededAbility to maintain a high degree of confidentiality with clinical data and client's proprietary dataAbility to act as a study or department expert for DM processes Ability to support project resourcing and project timeline planning and adherence to timelines #LI-DB1   skills: CRF, CDISC, CRFs, Clinical Data Management, GCP (Good Clinical Practice), ICH Regulations, Good Clinical Practice (GCP), Veeva Vault 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: Performs key operational activities across the Clinical Documentation Center for master files through life cycle. Collaborates with Master File Owners to support inspection readiness of clinical documentation / master files; may be aligned by Therapeutic Area but expected to work across all areas of the organization.   location: Telecommute job type: Contract salary: $26 - 30 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Applies critical thinking to ensure real-time inspection readiness of clinical documentation by: - investigates and proactively resolved issues - runs and performs review of reports and dashboards within eTMF - produces eTMF metrics - communicates to Master File owner(s) root cause analysis and potential data integrity concernsLeads to completion of the final reconciliation/review and archival of individual master files, working closely with the Clinical Documentation Associate (CDA), CDC leadership and other TMF stakeholders (i.e., CPD, SM&M, DSS, BSO).For CRO managed study TMFs: conduct QC of artifacts (may also include uploading and classifying); involvement with transfer of CRO TMFs into eTMF systemProvides audit and inspection preparation support for paper and electronic TMFs, to include, but not limited to (on selected master files): - conduct data integrity checks - run & analyze reports for TMF completeness - work with the assigned CDA to follow-up on outstanding items with other functional areas - contribute to completion of pre-inspection requestsDuring an inspection: - function at the subject matter expert of the eTMF system navigation, including being present in the front room with the Auditors/Inspectors - participate in responding to auditor/inspector requests (may be required to put the response together)Conduct TMF conversion activities; involvement with the transfer of TMFs from external entities (i.e., CRO, other pharmaceutical companies).Review regulatory documents / packages for approval of Investigational Product (IP) release and work with Artifact Owner(s) to correct errors. Provide approval for release of IP to investigator sites.Provides suggestions for CDC work instructions/job aides and contributes to functional area continuous improvement projects and/or work streams.Complies with GCP, SOPs and functional area processes.  qualifications: Qualifications Bachelor's Degree Minimum 4 years relevant industry experience in clinical document management or equivalent experience required. If no BS, a total of 6 years professional clinical research relevant work experience.Proficient knowledge of clinical documentation business procedures and compliant to clinical documentation processes, identify gaps and propose solutions.Capable of working autonomously with limited oversight.Proven oral and written communication skills; ability to facilitate cross-functional team meetings. #LI-AM1   skills: SOP, GCP (Good Clinical Practice), Trial Master File (TMF), Electronic Trial Master File (eTMF) 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: The Case Manager (Care Navigator 2) serves as the dedicated point of contact to patients and healthcare professionals when initiating treatment of company therapy. Responsibilities include navigating through onboarding, insurance verification, financial assistance, and ongoing support as requested by the patient and their healthcare professional. Case Managers will also be working with cross-functional team members within Patient Support, where appropriate, to ensure continuity of information being shared with the healthcare professional and patients. As a Case Manager, you will be assigned a specific territory to work within and become an expert in that regional area to best assist the individuals who call in, submit service request forms (SRFs) or required financial assistance. Case Managers will possess critical thinking and communication skills, an aptitude for learning and strive for continual development. The Case Manager must have strong communication skills to converse with customers about the patient's journey and be able to offer next steps in accordance with approved procedures. The Case Manager will possess an aptitude for learning, the ability to accept and implement constructive feedback, and a continual development mindset. In addition, the Case Manager will reflect a calm and reassuring tone and attitude for our patients, their families, and their caregivers, specifically during difficult or stressful interactions.   location: East Hanover, New Jersey job type: Contract salary: $25.40 - 32.00 per hour work hours: 8 to 4 education: High School   responsibilities: Develop and maintain Subject Matter Expert (SME) level knowledge of the relevant brand and customer workstreams for the specific assigned programLearn and utilize protocols to respond to customer phone, chat, fax, SMS / text, mail, and e-mail inquiries as well as other communication channels in a prompt and courteous mannerProfessionally and compliantly interact with customers, relevant associates, and other external contacts during inbound and outbound phone callsManage assigned cases throughout the patient journey; perform proper and timely escalation, tracking, triage and follow-up where requiredHandle complex interactions and/or cases as it pertains to navigating insurances and financial assistanceAdhere to call guides, job aides and work instructions for case processing and case cadenceAdhere to Service Level Agreements (SLAs), Key Performance Indicators (KPIs), productivity, and quality metricsLeverage dual monitors and technological solutions to support Case Management activitiesAccurately and concisely document all interactions to inform cross-functional partners on the relevant status detailsPromptly and courteously respond to tasks and notifications from PSC counterpartsAs applicable, raise innovative ideas which will drive improved efficiency and effectiveness of customer service to SupervisorsResponsible for identifying and reporting adverse events via the established systems as per applicable processes  qualifications: Required: High School Diploma required, associate or BS/BA degree preferredWhen working from home, a quiet dedicated space with internet/WiFi service or the ability to obtain such serviceMinimum 3 years of relevant patient service support experience (such as Healthcare, Pharmaceuticals, Patient Services or Contact Center ExperienceStrong interpersonal, telephone and verbal communication skills, including the ability to project warmth and compassion while effectively and efficiently conveying information Preferred: Experience working with Salesforce or other CRM platformsBi-lingual, Spanish speaking #LI-AL1 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.