Education & Qualifications:
- Master’s or Ph.D. degree in Life Sciences or a related field.
- Ten or more years of experience in clinical research and regulatory affairs, including 5 years of previous management experience
Duties & Responsibilities:
- Manages budgetary requirements and ensures compliance of expenditures to meet budget for clinical programs.
- Oversees clinical trial operations, including management of Contract Research Organization (CRO), clinical staff, and consultants.
- Facilitates Investigator Meetings, Core Lab processes.
- Oversees clinical trial operations, including IRB/Ethics committee approval, the provision of clinical trial materials (control of study devices), and overall operations management of the trial.
- Ensures that all aspects of GCP are complied with at all times for all aspects of clinical trial through training at start-up and initiation meetings for clinical trials and ongoing SOP development and implementation.
- Coaches CRAs in various aspects of management (e.g. HR, budgets, resource allocation) that are relevant to particular project issues.
- Implements training programs for CRAs and other contract clinical staff with topics that include: principles and practices of project management, team communication, computer software and IT training, protocol and CRF writing, adverse event reporting.
- Manages staff directing the development implementation and evaluation of clinical studies.
- Directs the development of systems, practices and processes to ensure efficient and effective clinical operations including clinical trial management, data analysis, final study report and publication.
- Represents the business medical professionals involved in clinical research with the Company.
- Develops and fosters relationships with luminary physicians.
- Collaborates with Marketing and R&D to organize workshops for meetings and regional company-sponsored symposia.
- Monitors and reports on clinical performance of products and study status and outcomes.
- Provides input on competitive technologies. Provides training to clinical sites on product use, clinical procedures.
Responsible for driving implementation of and continued compliance to global regulatory requirements, interprets and applies pertinent laws and regulations governing company products to meet business objectives.
Leads development, implementation and maintenance of regulatory processes at a company-wide level
- Leads WW regulatory submissions for Class II and Class III medical devices and biologics.
- Supports the development of regulatory strategies and application of the strategies to align with the business plans for a particular product
- Actively works with R&D, Clinical Research, Marketing, Quality to ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across indications for US and International regulatory submissions.
- Serves as main contact with US Food and Drug Administration (FDA) and liaises with other country Regulatory Agencies when needed, directly or in coordination with local country representation;
- Demonstrates sound understanding of related fields (e.g., manufacturing, product / process development, quality assurance) and the ability to diverse problem solving.
- Monitors the regulatory environment regionally/globally and provides assessments for the impact of new and changing regulations on the company’s areas of interest. Ensures new regulations or changes to existing regulations are communicated throughout the organization through company policies, procedures, and training.
- Leads representation of Regulatory on project teams and partner with the cross functions on the team to ensure alignment of regulatory strategy and plans with the team objectives.
- Supports and contribute into editing/revising Standard Operating Procedures.
- Develops and support training for global regulatory processes and system implementations.
- Builds team cohesiveness by leading, influencing, mentoring and motivating team members.