Duration: 24+ months contract
Job Description:
The Data Manager, Data Management Oncology Early Development (OED) is a member of the Data Management and Analysis team re sponsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Management & Analysis team within OED and internal colleagues to ens ure data integrity and quality for oncology first in human clinical trials up through clinical proof of concept.
Responsibilities:
• For assigned OED studies
o Provide CRO oversight and feedback related to the data management operations , issues and trends in performance
o Completes assignments as delegated by OED Data Management relating to operational objectives and study deliverables
o Effectively utilizes available technology, EDC platforms, Reporting and Visualization tools
o Reviews CRO deliverable to ensure adherence to data standards and protocol requirements implemented within the design
o Reviews study execution documents including specifications, data management plan, data review plan, data transfer plan and other cross functional plans delineating data review needs
o Provide CRO oversight of data management tasks in adherence with established standards including third party vendor data reconciliation, medical coding processing , protocol deviation collection, and query management to identify errors and inconsistencies in clinical data and ensure their resolution
o Identify and triage issues as they occur
• Ensures CRO data management adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and to data management quality standards.
Experience:
• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent.
• Must have at least 4+ years of pharmaceutical, clinical research, data management, health care or other relevant experience
• Strong understanding of clinical trial processes and clinical technology
• Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively
• Strong understanding of GCDMP
• Demonstrated effective communication skills
• Demonstrated effective problem-solving skills
Skills:
Education:
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Rahul
Email: [email protected]
Internal Id: 25-41754
...advertised. Contact Andrew Ameer at ****@*****.*** or (***) ***-**** to learn more about this opportunity. Flexible remote schedule: Work from home 3.5 weeks per month Only 2 - 4 days of in-person work required per month Modern practice offering TMS...
...34-hour resets at home - if you're stuck on the road for a reset, we pay you $150 and provide you with a hotel. ~ Mix of live load/unload and drop & hook accounts ~ PTO after 90 days ~ Ashley pays up to 80% of your health benefits. Insurance packages as low as $2...
...Description General Summary Under limited supervision, the Registered Nurse is responsible for the assessment of patients including the... ...of all job duties performed by personnel so classified. Clinical Practice: Provide independent care to unit-specific...
...of enterprise experience using web technologies like Angular, Typescript, JavaScript, Node.js, Cypress, Unit testing, Automation, HTML, CSS, Webpack, SASS, component libraries, Rest, Git, CI/CD practices and Testing (including complex unit tests, integration tests, etc)...
...UPMC located in Williamsport, PA is seeking a Physician Assistant or Nurse Practitioner to join our Center for Digestive Diseases. This dynamic group of 4 physicians/6 APPs is committed to providing the latest techniques & advanced procedures to their patients for the...