Vacancy expired!
Job Description: SMCI is seeking a CDM Systems Manager to work with a cross-functional team of internal stakeholders (including, but not limited to Quality, Supplier Governance, eCOA functions) and technology suppliers to ensure the quality of system-related processes and integrity of data at those IRT and eCOA suppliers for the compnay -sponsored clinical trials. The CDM Systems Manager will monitor the compliance of IRT and eCOA suppliers to ensure that their computerized systems and processes adhere to industry regulations / best practices as well as company policies, procedures and guidelines.
This position may be assigned to a client that requires all individuals on-site to have the COVID-19 vaccination. The individual must be fully vaccinated before starting work at such a client site.
Responsibilities:
Basic Qualifications:
Doctorate degree & 1 year of directly related experience
OR
Masters degree & 3 years of directly related experience
OR
Bachelors degree & 5 years of directly related experience
OR
Associates degree & 10 years of directly related experience
OR
High school diploma / GED & 12 years of directly related experience
Preferred Qualifications:
Bachelors Degree in life science, computer science, engineering, business or related discipline
Experience implementing clinical systems, such as IRT and eCOA
Work experience in information systems monitoring, quality assurance and/or auditing
Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, etc)
Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
Key Competencies:
Detail-oriented and able to manage many projects simultaneously
Excellent documentation and communication skills
Meeting management and facilitation skills
Excellent time management and organization skills in a timeline-driven environment
Sound problem resolution, judgment, and decision-making abilities
Work well in a team-based environment with minimal supervisionRequired Skills: Quality, Supplier Governance, eCOA, IRT; Don't hesitate! Submit your resume today. SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm. (No third parties, please)
Vacancy expired!