Publié dans: Autres dans Californie | Posté: |
Job Description
Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS
Study Team and represents DS as a member of the cross-functional study team
For assigned programs and studies, acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives.
Engages and connects global functional and cross-functional teams at the study level.
Interacts with and influences cross-functional team members to achieve program objectives
Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports.
Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards.
Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. If assigned, participates as the DS study owner in regulatory inspections and internal quality audits
Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance
Responsible for coaching and mentoring team members
Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives
Conducts study execution “lessons learned” across functions
May include indirect supervision of employee as well as supervision of work of contract resources
