Responsibilities Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc. Support GCP inspection readiness Demonstrate clear alignment with company Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence Performs other duties as assigned May involve travel Requirements: BS/BA in scientific discipline, MS or equivalent preferred, with at least 5 years related experience in a CRO/pharmaceutical/biologics/biotechnology company ----------Study/Vendor oversight experience Expert knowledge of Data Management processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH Experience working with EDC data management systems Understanding of ICH GCP as well as general knowledge of industry practices and standards Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11 Highly motivated and flexible, with excellent organizational and time management skills Ability to work independently and as part of a multi-disciplinary team Katalyst HealthCares & Life Sciences
...assistance Guaranteed base pay No lab fees FT providers are eligible to participate in Medical/Dental/Vision insurance plans, HSA/FSA Short Term Disability/Long Term Disability and Basic Life Insurance plans are paid for by company 401(k) Retirement Plan...
...$27 + $6 shift premium weekends worked* 15 days of paid time off* Competitive medical, dental, and vision plan options* Paid... ...Leave* 401(k) with an employer match up to 4%* AND MORE!The Roll-Off Driver will be responsible for safely, efficiently, and courteously...
...Serve as the primary lead for high-profile content production projects, overseeing all phases... ...! Our Core Values of Be One, Do Great Work, Have Fun, Give Back and Grow empower an environment... ...Hybrid Work model - ability to work from home or in office ~ Holidays and Winter Break...
...as well as aging adults. Maintains a clean and safe environment for individuals served, staff and visitors. Performs general housekeeping duties, such as cleaning bathrooms, dusting and vacuuming, using approved cleaning techniques. Commitment to Inclusion, Diversity...
Jimmy John's Delivery Biker's goal is to get that sandwich in the customer's hand as quick as can be. We do this by learning the most efficient... ...Must be at least 18 years old Must provide your own bike and helmet Work as an In-shopper when there are no deliveries...