Accountable for the activities of the Asia Pacific team members; managerial responsibilities including interviewing, terminations, training, coaching, performance management, goal setting and salary.
Perform some or all Project Management responsibilities on key projects as needed to support direct reports and clients.
Support project activities leading to building client relationships for defined customers and contracts; deliver “The Catalyst impact.”
Provide input into development of the planning and reporting framework using core systems and internal KPIs; review KPIs to monitor project delivery and client satisfaction.
Develop SOPs to govern the Asia Pacific function and identify/support development of project-specific SOPs.
Accountable for the financial management of projects and the Asia Pacific function; provide input into departmental budget, revenue recognition, project profitability, contract scope management and invoicing methodologies.
Represent Asia Pacific function during QA audits; ensure project and team readiness and complete CAPA responses to identified system/process weaknesses or customer complaints.
Support Business Development representatives with solutioneering, proposals, bid defense materials, and contracting of new business.
Other responsibilities and ad hoc projects as required.
Requirements
University/college degree (life sciences preferred) or certification in a related allied health profession (nursing, medical or laboratory technology).
Master’s Degree in scientific or business discipline preferred.
10+ years in a clinical research setting with a progression of increased responsibility over time.
2+ years of management experience in a CRO setting with in depth knowledge of the project management activities.
Previous exposure to and experience of Oncology specific clinical development complexities.
Strong knowledge of the drug development process and MFDS regulations, ICH GCP guidelines, and their application to clinical trials.
Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes.
Proficient with Microsoft Office Suite.
Excellent written and oral communication skills; excellent presentation skills.
Strong organizational, problem-solving, and analytical skills; ability to manage priorities and workflow.
Versatility, flexibility, and willingness to work within constantly changing priorities; proven ability to handle multiple projects and meet deadlines.
Strong interpersonal skills; ability to deal effectively with a diversity of individuals at all organizational levels.
Good judgement with the ability to make timely and sound decisions.
Ability and willingness to travel to investigator meetings, investigator sites and bid defense meetings, etc., up to 10%.
Applicants must be authorized to work for ANY employer in South Korea; employer cannot sponsor or take over sponsorship of an employment visa.