Clinical Data Manager
The CAPA Coordinator is a member of the Pharmaceutical R&D Quality and Compliance, Quality Processes Liaisons team.
He/she will contribute to the strategic design, implementation and delivery of global compliance to ensure that the programs and functions for Client (and all partners) are in compliance with company standards, Health Authority (HA) guidelines and regulations.
This includes but is not limited to non regulated, preclinical, clinical (Phase 0 - 4), pharmacovigilance, and information technology.
Responsibilities:
As a CAPA Coordinator, he/she will be responsible to:
Perform and Manage Manual data entry for CAPA Management system and assist business
Assist business with Root Cause Analysis for Health Authority Inspections, Mock Inspections and internal audits
Create CAPAs and Effectiveness Check records in Audit Database and other repositories
Assist in the monitoring of new observations in Audit Database & data entry of CAPAs into CAPA platform until system interfaces are availble
Data entry of CAPAs into appropriate system(s) (e.g., electronic database), including assurance of data quality in alignment with appropriate conventions.
Assist in management of a shared mailbox for receipt of audit report responses and distribution of audit-related CAPA information.
Generate weekly and monthly CAPA trackers, metrics and presentations for updates to senior management.
Ensure Organize, file and archive supporting documentation for CAPA records.
Assist with management of data/information in the Pharmacovigilance System Master File (PSMF).
Assist with the development of BI reports to generate consolidated reports including audit observations and CAPAs
Attend project/Team meetings and provide status updates
Assist with User Training and project implementation
Assist business with data entry as requiredOther responsibilities as required.
Position
Qualifications:
A Bachelor of Science (BSc) or Arts (BA) degree or equivalent degree is required.
A minimum of 1 year experience in a medium to large scale matrix organization which includes applicable compliance related field and/or equivalent time and experience in a related R&D area is required.
Requires knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques.
Related
Experience:
Prior experience in a compliance related field.
Prior experience with quality management systems.
High degree of computer proficiency, with ability to utilize multiple databases and software programs.
Ability to translate data into information and strategies into executable action plans.
Ability to motivate professional colleagues and stakeholders
Conflict resolution/management and negotiation skills
Ability to independently plan, organize, coordinate, manage and execute assigned tasks
Experience of the key customers' business processes and practices; experience of the overall drug development process is an asset
General Skills:
Problem solver
Proactive strategic thinker
Strong leader and collaborator
Highly committed to quality
Flexible and persistent
Good conflict handling/negotiation skills
Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks
Excellent communicator and presenter , with excellent interpersonal skills and diplomacy
Excellent knowledge of English is required
Proficient in Microsoft Office applications
Able to create win-win situations with internal and external partners
Stakeholder contacts are frequent and require excellent interpersonal skills and diplomacy
Knowledge of the corporate structure and culture
Other Skills and Abilities: Requires little supervision and functions independently. Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service.Estimated Salary: $20 to $28 per hour based on qualifications.
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