Abbott Global Clinical Operations, Process & Training Manager in Singapore, Singapore
Primary Job Function
The Manager Clinical Operations, Process and Training supports the efficient and compliant execution of Clinical Development and Medical activities to internal and external standards by taking responsibility for the maintenance and training of Global Clinical Development & Medical Affairs (CD&MA) Quality System documents.
Core Job Responsibilities
Develops, and maintains EPD CD&MA quality system documents, adopting Abbott corporate and external standards (ICH/GCP & relevant regulatory requirements)
Serves as subject matter expert and point of contact for CD&MA personnel and cross functional stakeholders for process-related questions
Drives the continuous improvement of global CD&MA policies and procedures; harmonizes activities, promotes best practices
Develops and executes CD&MA compliance strategy. Implement and track compliance metrics and KPI’s. Identify and remediate area’s of non compliance in close collaboration with compliance functions (QA, OEC)
Leads CD&MA audits and inspection activity.
Ensures inspection readiness of CD&MA Global function and promotes inspection readiness in regional/affiliate CD&MA teams.
Assures CD&MA personal have appropriate training plans assigned; promotes and enhances training compliance and manages non-compliance
Identify, on an ongoing basis, operational training needs and coordinate training delivery, where appropriate
Supports in the training and on-boarding of newly hired CD&MA staff
Supervise the Therapeutic Area Review Committee process and assures appropriate process administration
Assures implementation of CD&MA systems and tools in close collaboration with systems owners. Develops strategy to assure data quality.
Collects and processes functional metrics, prepares reports to support Clinical Operations Management decision-making
Takes ownership of continuous learning to stay aware of evolving Abbott policies, regulations and industry practices affecting our procedural standards and quality system documents
Responsible for the maintenance of global quality system documentation and associated training material relevant for Clinical development and Medical Affairs
Provides leadership to relevant administrative, process and training related resources
Internal stakeholders: Clinical Development and Medical Affairs team; Quality Assurance, Pharmacovigilance, Regulatory Affairs, Office of Ethics and Compliance: global, regional and local
External stakeholders: business partners (contractors, consultants, vendors)
- Bachelor/Master of Science in a field related to life sciences or equivalent by experience
At least 10 year experience in Clinical / Medical Affairs Operations
At least 3 years managerial experience in Quality System Management (Development & maintenance quality systems documents and training delivery)
Experience in Pharmaceutical or CRO environment is preferred
Experience with working in a Global fast paced environment
People / Line Management experience
Proven Project Management skills
Expert in MS office applications especially Excel and PowerPoint
Fluent in English
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org