PSI is a leading Contract Research Organization with 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
SCOPE OF RESPONSIBILITIES
1. Core responsibilities (the scope of responsibilities may vary and is dependent on project allocations and study startup process specifics in the country/region)
1.1. The Study Startup Manager leads study startup in 1 to 3 assigned countries on projects within a region starting from project start until site activation.
1.2. Ensures that startup deliverables in assigned countries are met.
1.3. Participates in development and update of project/country startup and site activation timelines.
1.4. Acts as a primary or secondary contact for client and vendors for startup matters within assigned countries. 1.5. Reviews the quality metrics and reports quality issues.
1.6. Ensures startup team compliance with project-specific training matrix and trains project team on Study Startup processes.
2. Resource Management & Training
2.1. Assists with Study Startup resource allocation in the assigned country(-ies).
2.2. Develops training materials, delivers training and provides methodological support to operational staff in within the assigned country(-ies).
2.3. Mentors and coaches assigned department staff in the country.
2.4. Takes up line management responsibilities for local Study Startup team members within assigned country(-ies).
3. Quality Assurance and Process Improvement
3.1. Identifies and escalates country-specific startup operational issues regional leads.
3.2. In cooperation with the Line Manager, monitors startup key performance indicators for projects in startup on a country level and implements improvement plans.
3.3. Develops and updates manuals, local instructions, and user guides relevant to Study Startup activities within the assigned country and provides local expertise and best practices to other PSI functions and clients.
Qualifications1. Bachelor's or above degree in Life Sciences or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities.
2. At least 7 years of Study Startup experience in the country/region and over 3 years of experience in a Lead/Line Manager role.
3. Communication, presentation, and customer-service skills.
4. Team building, leadership and organizational skills.
5. Full working proficiency in English and Chinese.
6. Proficiency in MS Office applications, including MS Project.
Additional InformationMake the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
Skills Required
- Bachelor's or above degree in Life Sciences
- At least 7 years of Study Startup experience
- Over 3 years of experience in a Lead/Line Manager role
- Full working proficiency in English and Chinese
- Proficiency in MS Office applications including MS Project
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com
