Provide input on Data Management related study plans including Data Management Plan (DMP), Data Validation Plan, Data Review Plan, CRF Completion Guidelines, and other study documents to ensure quality and standardization; may be responsible for updating DM documents to ensure they are up to date
Contribute to development of initial and updated eCRF designs, including database UAT
Assist in development of global library standards and comply with global library process
Contribute to development and implementation of edit check specifications and work with database programmer on edit check development and validation
Facilitate transfer of data from external vendors, which may include finalizing Data Transfer Agreement/ Specifications and verifying test data per specifications document
Work with internal programmers to develop ad hoc SAS listings, patient profiles, and other outputs
Run and review outputs and database study metrics; identify discrepancies to assist in data cleaning
Participate in data reviews with clinical team to ensure accuracy, consistency, and reliability of data
Review discrepancies in EDC system, monitor/facilitate resolution and closeout or re-query per study guidelines; note and communicate trends to clinical trial manager(s) for follow-up
Facilitate identification and capture of Protocol Deviations, if applicable
Reconcile external data to clinical study database and perform Serious Adverse Event reconciliation
Work with study teams to ensure study databases are locked based on pre-defined criteria and established timelines
Ensure DM procedures and processes are adhered to in a consistent manner
Requirements:
At least 3+ years of clinical data management experience in the pharma/biotech industries
Experience with DM activities including Database Build, Study Startup, Study Conduct, and Database Closure
Hands on experience with Medidata RAVE is required and experience using ad hoc query tools required (J Review, other desired)
Experience in CRO and vendor management is a huge plus
Experience with multiple phases of clinical development highly desirable
Associates Degree or higher is required, bachelor's degree is preferred
إخلاء المسؤولية: د.جوب هو مجرد منصة تربط بين الباحثين عن عمل وأصحاب العمل. ننصح المتقدمين بإجراء بحث مستقل خاص بهم في أوراق اعتماد صاحب العمل المحتمل.
نحن نحرص على ألا يتم طلب أي مدفوعات مالية من قبل عملائنا، وبالتالي فإننا ننصح بعدم مشاركة أي معلومات شخصية أو متعلقة بالحسابات المصرفية مع أي طرف ثالث. إذا كنت تشك في وقوع أي احتيال أو سوء تصرف، فيرجى التواصل معنا من خلال تعبئة النموذج الموجود على الصفحة اتصل بنا