clinical case manager

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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting 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: Cambridge, Massachusetts job type: Contract salary: $99.65 - 117.31 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Responsible for timely and high quality data management deliverables supporting the company's portfolio.Establish asset and study level strategies and services, including excellence in the application of standards.Conduct oversight using, predictive data monitoring practices from database activation through database release and submission.Contributes to the management of vendor partnerships to maximize effectiveness and maintain budgets.Provides and enables solutions for complex problem solving that align with the company's values.Serves as a clinical data management expert and provides guidance on CDISC standards.Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and the company for all data related deliverables, especially in support of key decision points and regulatory submissions.Contributes influential leadership in collaboration with other company Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.Provides input to functional governance with the company's strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documentsOversees the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of the company.Participates and represents function in formal inspections and audits as requested.Other duties as assigned  qualifications: BS/BA required preferably in a health-related, life science area and with a minimum of 10 years data management and/or drug development experience.Proven track record of strong project management skills and experience managing data management activities for large drug development programsExperience with all phases of development and at least 2 therapeutic areas.Ability to handle multiple development programs simultaneously.NDA/CTD Experience.Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.Good understanding of CDISC standards, and experience implementing standards.Strong knowledge of clinical study reporting requirements including SAS programming.Advanced knowledge of office software (Microsoft Office).Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles.Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools.Good working knowledge of general statistical programming processes and practices.Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.Ability to sit and stand for long periods of time.Carrying, handling and reaching for objects.Manual dexterity to operate office equipment i.e. computers, phones, etc.Access to transportation to attend various meetings held in proximity to the company offices.Able to fly to various meetings at investigator, vendor or regulatory agency sites.Some international travel may be required.  skills: NDA, CDISC, CRFs, Clinical Data Management, CTD Structure, TMF 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. 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. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the 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: San Rafael, California job type: Contract salary: $59.90 - 70.47 per hour work hours: 8 to 4 education: Bachelors   responsibilities: Duties: For assigned study(ies), the Study Manager is accountable for day-to-day Clinical Operations study execution and related deliverables and is the primary point of contact within Clinical Operations for a study. Key responsibilities include: Managing risks, issues and opportunities that impact timeline, quality, and budget, overseeing the Clinical Operations study team, vendors and CRO, and collaborating with cross-functional representatives to execute on study deliverables.  qualifications: Skills: The candidate is expected to show and have proficiency and experience in the following competencies: Decision Making, Strategic Thinking, and Problem SolvingInfluence and Organizational AwarenessAgility and Proactivity Communication and Collaboration With advanced technical competencies in many of the following areas: Study Management and Execution Compliance and Quality Data Analysis and Interpretation Drug Development and Study Design Product and Therapeutic Area Knowledge Education: Minimum BA/BS7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CROExperience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)  skills: 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.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. 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. 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 mission of the Biology Research department is to conduct preclinical research evaluating potential therapeutics for severe rare diseases with unmet medical needs. Our team in the non-oncology hematology group uses state-of-the art equipment to provide biochemical and molecular biology support to a variety of pre-clinical projects. We are searching for a self-motivated Technical Scientist with 4-8 years of hands-on laboratory experience. The successful candidate will develop and use biochemical assays to measure pharmacodynamics, pharmacokinetics, immunogenicity and biomarkers of new therapeutics. The Technical Scientist will work closely with a team of dedicated researchers and will have the opportunity positively impact the lives of patients with rare diseases.   location: San Rafael, California job type: Contract salary: $47.92 - 56.38 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Develop and use a variety of analytical methods to detect biomarkers, drug, and antibodies in biological matrices. Techniques may include (but are not limited to) ELISA, enzyme activity assays, DNA / RNA extraction and droplet digital polymerase chain reaction (ddPCR).Develop new techniques, or bring in new technology from the outside, to enhance the analytical capabilities of the group.Present results, conclusions, and implications to project teams.Meticulously adhere to electronic data recording standards.Share responsibility for lab management duties.Contribute to reports and peer-reviewed publications.This role is primarily based at the bench / in the lab.  qualifications: Bachelor's degree (BS) and at least 10 years of experienceMaster's degree (MS) with at least 8 years of relevant experience8-10 years of laboratory experience, or demonstrated experience as an independent researcher.Broad technical proficiency and ability to solve complex scientific and technical issues independently.Experience with handling animal tissues is desired.Excellent verbal and written communication skills: ability to prepare and present data in group settings, prepare formal reports, communicate across functions.The position requires organizational skills, self-motivation, teamwork, and dedication to quality in a fast-paced setting. Hands-on experience performing molecular biology, immunoassays, or other analytical methods in a biological or biochemical field.Working knowledge of cell and molecular biology and biochemistry. This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   skills: Molecular Biology, Cell Biology, PCR, Immunoassays 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.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. 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. 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.