Job-ID31716268Reference26-00054 Responsibilities: Maintain and update EDC user access across multiple clinical studies Track and manage user access requests in coordination with CRAs and EDC vendors Curate and maintain standardized tracking spreadsheets for both internal and external use Transfer verified data from working trackers to production master user lists Respond to and resolve user-related queries from study teams and EDC builders Prepare and upload CDM documents to the Trial Master File (TMF) in compliance with internal SOPs and TMF standards Track document status and ensure completeness and accuracy of TMF content Collaborate with Sr. CDMs to ensure documents are audit-ready and filed in a timely manner Assist with study startup, maintenance, and closeout CDM activities as needed Participate in team meetings, training sessions, and cross-functional collaboration Support documentation and version control for CDM tools and templates Maintain clear and organized records of work performed All other duties as assigned Requirements: Bachelor's degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience. 6+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required Ability to perform well-defined procedures initially with supervision, and after direction is provided, work independently Ability to work effectively in a team-oriented environment Flexibility to adapt to changing project requirements and timelines Excellent attention to detail and organizational skills Strong communication and collaboration abilities Proficiency in Microsoft Excel, Word, and document management tools Strong organizational skills to manage multiple tasks and projects simultaneously Preferred : Experience with EDC systems (e.g., Medidata Rave, Oracle InForm) Familiarity with TMF structure and regulatory filing practices Understanding of GCP, GCDMP, and clinical trial workflows
...STD/LTD, Supplemental Insurance, Paid Vacation, Paid Holidays, and matching 401(k). Requirements: - Valid electrician's license-3 Years proven experience as an electrician in various settings, and oilfield related experience - Strong knowledge of electrical systems...
Job ID: 21134910Reference Number: 24-00085Title: python developerLocation: Iselin, NJ, 08830Posted Date: 2024-01-18Contact: Shyam MaramContact... ....comContact Phone: (***) ***-****Company: HAN Staffing Python Developer with Very strong CoderRemoteno Fake ****@*****.***....
CenterWell Home Health, part of Humana Inc., is seeking a Home Health Licensed Vocational Nurse to deliver skilled in-home nursing for seniors and adults with chronic conditions. In this role, youll provide assessments, medication administration, wound care, and patient...
...PCR/qPCR experience and strong molecular biology skills who are motivated to contribute... ...compliance with GDP.Qualifications Bachelors degree in Life Sciences (Biology, Chemistry,... ...employment physical required.Seniority level Entry levelEmployment type ContractJob...
...Transplant Coordinator Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers...