Life Science CDM Job The position of the CDM is also expected to manage basic science questions/queries, clinical development tasks associated to the management of trial data, and internal Omeros projects. The CDM adheres to Omeros Standard Operating Procedures (SOPs), work practices, applicable clinical trial regulations, and study confidentiality requirements and functions with limited supervision in operational and technical matters within defined procedures and practices.
Education, Skills and Knowledge
· Requires a university degree, BA/BS, ideally with a degree in a Life Science, Library Sciences or Computer Science
· 3+ years of experience as a CDM in a pharmaceutical or CRO setting
· Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle) is preferred
· Proficiency in the development and use of commercial EDC products, preferably Medidata RAVE/Balance/CTMS
· Proficiency in MS Office Suite (including Word, Excel, PowerPoint)
· Knowledge of FDA regulations and ICH, GCP and GCDMP guidelines
Behavioral Competencies Required:
· Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates as well as vendors
· Demonstrated ability to develop and present varied and unique ideas
· Ability to display strong analytical and problem-solving skills
· Detail orientation required
Physical Demands Required:
· May encounter prolonged periods of sitting
· May frequently be performing repetitive movements such as typing on a keypad or using a mouse
· May climb, bend, reach, push, pull, balance, stoop, kneel, or crouch
· On occasion, may lift and/or move up to 20 pounds
What are your job responsibilities?
· Manage study/project implementation including but not limited to leading Omeros team members through CRF, lab, and other data collection processes, reporting and analysis requirements, study/project documentation and training
· Effectively manage assigned protocol/study, establish timelines and milestones in conjunction with department management, and monitor and communicate ongoing status and progress
· Ensure rapid resolution of issues/conflicts using appropriate internal and/or external resources, tracking and managing the escalation of issues to ensure appropriate resolution in a timely manner
· Participate in development of a protocol/study from draft status to optimize the collection of accurate and high-quality data
· Work with project sponsors, stakeholders, and cross-functional team members to define project requirements, scope, risks, organization, and approach
· Act as subject matter expert for data management issues between study team staff and external domestic and international research sites for assigned studies
· Assist in the development of Case Report Forms (CRF’s) for assigned studies
· Collaborate in the design of the protocol/study specific database for assigned studies
· Assist in the maintenance of the study database including routine revisions or additions to include the design and/or modification of routine and existing study database edit check programs for assigned studies
· Perform User Acceptance Testing (UAT) for assigned studies
· Monitor study data to ensure the quality and completeness of the data submitted by implementing quality control procedures
· Generate QC reports for site review and correction as well as a variety of other reports required
· Evaluate study data for protocol compliance
· Maintain the documentation of the study database and other related data management programs and/or applications
· Ensure that Omeros meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP)
· Complete studies/projects ensuring completeness, documentation and storage
· Assist in the development of Omeros procedures and best practices as warranted
· Assist in the development and maintenance of standardization tools and training materials as requested
Life Science CDM Job, Life Science CDM Job
