Associate Director, Clinical Operations
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We’re looking for a talented and energetic Associate Director, Clinical Operations to join our team in South Korea. This is a permanent role and will be a home based position.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
In this role, you will have the opportunity to hold the overall responsibility for the leadership and management for Clinical Operations and country level functions in South Korea.
This includes being accountable to:
- Work closely with both Korea and global sales to promote Premier Research capabilities to local and global customers; build relationships with KOLs, PIs and Sites in Korea
- Ensure effective, quality and on time delivery within allocated budgets and oversee staff utilization and productivity
- Manage clinical operation staff including mentor, coach and train Clinical Operation employees and participate in the recruitment, retention and ongoing professional development
- Direct the development and management of departmental performance metrics, training and training standards for your region
- Ensure compliance to Korean Government policies and local Regulatory bodies
- Manage clinical operations employee resources and employee resource projections to ensure that project teams meet client expectations and contractual obligations
- Interface with other departments to design cross-functional process efficiencies or develop new approaches to the clinical management and monitoring considering Phase I - IV paradigms
- Liaise with Clinical Operations colleagues globally to ensure continuity throughout, as well as with other Premier Research Group departments to ensure the success of all project initiatives
- Ensure customer audit and regulatory inspections preparedness, including training records, processes, and SOP compliance
- Review RFP’s, assess monitoring strategies and resources to support budget development
- Accountable for a library of information for Clinical Operations
- Contribute to Business Development including evaluating and defining specifications for sourcing and working with strategic hiring; participate in Business Development presentations
- Take the initiative to move the project/program forward by using tools available to appropriately source staff
- Ensure and deliver appropriate transition planning and stakeholder communication for any handovers or change in staffing
- Participate in corporate initiatives and actions to ensure continued success of Premier
- Must be available to perform overnight travel, as required
You will need this to be considered:
- Recognized undergraduate degree, with preference for degree in Pharmacy, Biology, Chemistry, Psychology, Nursing
- Minimum of 10 years clinical research experience including a minimum 5 years supervisory / management experience including oversight of larger groups; Proven people manager able to guide staff through major changes, encouraging teamwork and developing team capabilities
- Proven interpersonal skills able to work and lead efficiently within a matrix environment
- Ability to drive projects to a successful completion both as a project leader and within a leadership role
- Strong organizational skills with the ability to handle and prioritize and multi-task multiple assignments in a fast-paced work environment
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions; ability to communicate at all levels in English; excellent communication skills (verbal, written and interpersonal) and negotiation skills
- Knowledge of ICH / GCP regulations; working knowledge of local country regulations (e.g, FDA and EMA Guidance Documents /NA Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of web based communication tools for conferences
- Excellent team player, collaborative and able to build an effective team
- Accountable, dependable and strong commitment.
- Is customer service focused in approach to work both internally and externally
- Maintains a positive, results orientated work environment