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
ยท Requires a university degree, BA/BS, ideally with a degree in a Life Science, Library Sciences or Computer Science
ยท 3+ years of experience as a CDM in a pharmaceutical or CRO setting
ยท Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle) is preferred
ยท Proficiency in the development and use of commercial EDC products, preferably Medidata RAVE/Balance/CTMS
ยท Proficiency in MS Office Suite (including Word, Excel, PowerPoint)
ยท Knowledge of FDA regulations and ICH, GCP and GCDMP guidelines
Behavioral Competencies Required:
ยท Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates as well as vendors
ยท Demonstrated ability to develop and present varied and unique ideas
ยท Ability to display strong analytical and problem-solving skills
ยท Detail orientation required
Physical Demands Required:
ยท May encounter prolonged periods of sitting
ยท May frequently be performing repetitive movements such as typing on a keypad or using a mouse
ยท May climb, bend, reach, push, pull, balance, stoop, kneel, or crouch
ยท On occasion, may lift and/or move up to 20 pounds
What are your job responsibilities?
ยท 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
ยท Effectively manage assigned protocol/study, establish timelines and milestones in conjunction with department management, and monitor and communicate ongoing status and progress
ยท 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
ยท Participate in development of a protocol/study from draft status to optimize the collection of accurate and high-quality data
ยท Work with project sponsors, stakeholders, and cross-functional team members to define project requirements, scope, risks, organization, and approach
ยท Act as subject matter expert for data management issues between study team staff and external domestic and international research sites for assigned studies
ยท Assist in the development of Case Report Forms (CRFโs) for assigned studies
ยท Collaborate in the design of the protocol/study specific database for assigned studies
ยท 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
ยท Perform User Acceptance Testing (UAT) for assigned studies
ยท Monitor study data to ensure the quality and completeness of the data submitted by implementing quality control procedures
ยท Generate QC reports for site review and correction as well as a variety of other reports required
ยท Evaluate study data for protocol compliance
ยท Maintain the documentation of the study database and other related data management programs and/or applications
ยท Ensure that Omeros meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP)
ยท Complete studies/projects ensuring completeness, documentation and storage
ยท Assist in the development of Omeros procedures and best practices as warranted
ยท Assist in the development and maintenance of standardization tools and training materials as requested
Life Science CDM Job, Life Science CDM Job
