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.