Clinical Data Manager (CDM)

Description Every day, Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. KSR is the first and largest scientific staffing company in the world, and we currently have an exciting Oracle Clinical Global Librarian position available in the Mansfield MA area.
By working with Kelly Scientific Resources, you will receive: - Competitive pay - Eligibility to a comprehensive benefits package - Access to the Kelly Science Learning Center - The opportunity to gain experience and references at one of the world's foremost pharmaceutical companies - And more!
We are looking for an individual who will be responsible for maintenance of the central repository for the objects that compose data collection definitions for clinical studies. They will: ' Store standard versions of the study collection objects for reuse in other studies ' Define separate domain within the Global Library ' Is a centralized resource supporting multiple business unites and key stakeholders within Clinical, Data Management and Medical Affairs ' Have a commitment to delivering the highest quality work, a strong sense of task ownership and the ability to excel in a fast-paced, team-oriented environment. ' Review all new CRF modules ' Manage CRF annotations and new objects ' Create new questions and maintain all new Global Library objects ' Monitor the study usage of questions, question group and other elements created in the Global Library. Setting of the status of entities stored. ' Document activities and work according to SOPs and work instructions.
Education and experience required:
BA/BS degree in computer or life science of equivalent combination of education and experience. A minimum of 7 years experience supporting production as a system administrator, database administrator or global librarian in Oracle Clinical. Experience with Remote Data Capture (RDC). Expert-level development skills in PL/SQL and SAS. Requires knowledge of systems development life cycle, relational databases and clinical trials database design, development and maintenance. Knowledge of ICH/GCP/FDA regulations and guidelines as they pertain to clinical data management.
Preferred Skills: Broad knowledge of PL/SQL, SQL Scripting and UNIX. Experience with clinical Data Warehouse maintenance preferred. Additional Oracle experience may include developer/programmer experience with Clinical Data Management experience highly preferred. Preferred therapeutic areas: device and pharmaceuticals.
Strong oral and written communication skills, project management skills. Capable of production-technical support, training users and generating documentation. Time management and organizational skills.
Kelly Scientific Resources® has grown into a $270 million global business as the scientific business unit of Kelly Services. We provide clinical research and scientific staffing to pharmaceutical, biotechnology, medical device and contract research organizations across the US. Kelly Services is an Equal Opportunity Employer.
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Requirements BA/BS degree in computer or life science of equivalent combination of education and experience. A minimum of 7 years experience supporting production as a system administrator, database administrator or global librarian in Oracle Clinical. Experience with Remote Data Capture (RDC). Expert-level development skills in PL/SQL and SAS. Requires knowledge of systems development life cycle, relational databases and clinical trials database design, development and maintenance. Knowledge of ICH/GCP/FDA regulations and guidelines as they pertain to clinical data management.