clinical case manager

job summary: Sr. Manager, Clinical Supplies (Oral Solid Dose) 6 Month Contract (may extend or convert) Remote (75%) + 1 week / month in South SF Looking for West Coast Based Candidates (travel reimbursed) Must Have: Experience with oral tablet dosage form Phase 1 & Small Biotech experience APAC logistics experience is a plus Strong MS Excel skills Seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning and Logistics with experience in clinical supply planning and logistics. This role is responsible for forecasting Investigational Product (IP) supply requirements, managing packaging, labeling, and distribution through 3rd party vendors, for one or more clinical trials. Collaborates and interacts internally with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, CMC and externally with Clinical Service Providers (e.g., CROs, IP Drug Depot).   location: South San Francisco, California job type: Contract salary: $75 - 95 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Manage all aspects of IP supply planning and logistics, to ensure alignment with study plans, timelines, budget, and overall clinical development plan.Management of IP vendors (performance, quality, timelines, results, costs): participates in review of RFP, reviews IP services vendors budgets.Manages relationships with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trialsCollaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulationsWorks closely with QA to ensure compliance around IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules.Manages clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up through study closure, label generation and approval, packaging and labeling operations, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management.Assists the design and review of IP-related study documents (e.g., pharmacy manual, IP section of protocol) and training materials for clinical study teams and investigational site use as needed. Supports inspection team in preparation for and during regulatory agency inspection.Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists  qualifications: Required: BA/BS required, preferably in a scientific discipline. Other BA/BS degree with clinical supply experience will be considered.6+ years of relevant experience in the biotechnology/pharmaceutical industry, including at least 3 years in clinical supply management in a small biotech-type of environment.Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, blinded global studies requiredExperience in IP logistics in APAC (e.g., IP manufacturing and import from Asia to US) preferredKnowledge of global pharmaceutical regulatory requirements: cGMP, GCP, GDPExperience in forecasting, labeling, and distribution in clinical environmentPhase one study experience (FIH, Single Center, etc.) preferred.Understanding and proven experience in IRT/RTSM,Clinical Supply and similar vendor management experienceKnowledge of import/export policies Core competencies and skills The ability to prioritize and handle multiple activities on a daily basis while being flexible and responsive to frequently shifting prioritiesDemonstrated ability to integrate into a partially remote team environment (US, APAC) with a positive attitudeAction-oriented with excellent problem-solving skillsStrong sense of integrityOther qualitative requirements: Organizational skillsResult-drivenStrategic agilityResilience and flexibility dealing with ambiguity #LI-AT1   skills: Phase I, Clinical Supply Chain, Clinical Trial Supply Strategy 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. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

job summary: The Senior Clinical Development Scientist for the Ultrasound group will be responsible for developing, generating, and disseminating clinical and economic evidence ensuring innovation, and transformation with best-in-class clinical evidence. Your role: Contribute strategic guidance for clinical and economic evidence related to the end to end (E2E) development process from ideation through post-market for products in the Ultrasound business.   location: Bothell, Washington job type: Contract salary: $85.00 - 94.78 per hour work hours: 9 to 5 education: Doctorate   responsibilities: Collaborate with key internal and external stakeholders to provide in-depth expertise to develop and lead clinical initiatives through non-clinical and clinical strategies for new product development initiatives and product life cycle management.Drive execution ensuring quality and timeliness of clinical programs and/or trials to support critical regulatory requirements, be agile and responsive during course of design, execution, and interpretation of trial data.Collaborate with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations; and additionally, to support claims, reimbursement, health economic outcomes and/or market access.Ensure appropriate preparation, interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, as assigned.Lead or support scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, in line extensions, including during sponsor regulatory inspections.   qualifications: Required PhD or MD with a science background7+ years of experience in clinical research/development/real world evidence (RWE); scientific study design, strong scientific background and experience with Artificial Intelligence algorithm clinical performance validation.Deep expertise including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics.A demonstrated working knowledge of GCP, FDA regulations and EU-MDR regulations, and in-depth understanding of product development and associated design controls for medical devices.Strong writing skills to product quality clinical documents, including final reports. Travel up to 15% (domestic and international) according to business needs. Preferred Strong knowledge and experience with study designAn ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications.Present statistical methods and results to a variety of audiences, especially non-statisticians. #LI-CV1   skills: FDA, CSR, GCP (Good Clinical Practice), Clinical Study Design 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: Company is seeking a Clinical Laboratory Technologist to support clinical lab operations. This role will be responsible for performing high complexity laboratory testing on patient specimens, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. The work requires maintaining meticulous and organized records, excellent attention to detail, the ability to multitask, be flexible with tasks and schedules and the ability to work independently in a team environment.   location: Durham, North Carolina job type: Contract salary: $37 - 39 per hour work hours: 3 to 11 education: Bachelors   responsibilities: Perform tasks which require the exercise of independent judgment and responsibility, with minimal supervision by the director or supervisor. Perform pre-analytical and analytical procedures including testing, quality control, preparation and aliquoting of reagents, analyses, and maintain records of tests according to the laboratory's standard operating procedures. Maintaining records that demonstrate proficiency testing samples are tested in the same manner as patient specimens. Adhere to laboratory's quality assurance procedures, including documenting all: Quality control activities Instrument and equipment verifications Maintenance and preventive maintenance Follow the laboratory's policies and procedures whenever test systems are not within the laboratory's established performance specifications. Identify and document problems that may adversely affect test performance and notifying the supervisor, assistant director, or director. Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications. Operate and maintain laboratory instruments and equipment according to laboratory standard operating procedures. Troubleshoot and problem solve minor instrument issues. Check and record temperature and instrument status or initiate a service request as necessary.  qualifications: MUST HAVE'S Bachelor's degree in medical technology or laboratory science from an accredited institution Or Bachelor's degree in one of the chemical, physical, or biological sciences from an accredited institution and at least 6 months of acceptable supervised experience and/or relevant training 1-2 year of clinical laboratory experience Working knowledge of local, state and federal laboratory regulations. Able to integrate and apply feedback in a professional manner Able to prioritize and drive to results with a high emphasis on quality Ability to work as part of a team within a highly collaborative environment Strong automation and computer skills Ability to analyze and solve basic issues that impact the performance of the assay Ability to proactively communicate consistently, clearly and honestly Ability to prioritize tasks with a high emphasis on quality Ability to participate in projects and complete assignments as expected Flexibility of work schedule to meet the needs of GRAIL's Clinical Laboratory PHYSICAL DEMANDS/WORKING ENVIRONMENT Hours and days may vary depending on operational needs Standing or sitting for long periods of time may be necessary May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation Repetitive manual pipetting may be necessary Some lifting (up to 25 pounds) may be necessary #LI-TD-1   skills: Immunoassays, Sample Preparation, Sample Testing 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.