GSS Manager

Business Title GSS Manager
Requisition ID 23789BR
Job Category Clinical Research
Locations Singapore
Shift 1
Job Posting . Responsible for the management of site start-up activities
. Responsible for line management of GSS personnel: hiring, mentoring, performance management; ensuring understanding of project specific and GSS policies and procedures for direct reports in single or multiple offices
. Provide local leadership in the development and implementation of the CDS P3 (Predictive + Proactive + Preventative) model and in the direct supervision of staff concerned with site start up activities and project feasibility
. Work with staff in Operational Strategy &Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organizations to develop evidence-based plans for the successful implementation and conduct of global clinical trials.
. Assure that pre-study, drug supply and labeling processes comply with applicable guidelines and regulations and fulfill client and Covance requirements.
. Supervise GSS staff in performance of their day to day work, including management of resource allocations
. Provide logistical support for clinical trial supply coordination
. Provide GSS input into business development activities
Education/Qualifications . University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
In lieu of the above requirements, candidates with >five (5) years supervisory experience in a health care setting and four (4) years clinical research experience including monitoring in the pharmaceutical or CRO industries will be considered
. Thorough knowledge of ICH Guidelines and GCP, the clinical trial process and a basic understanding of regulatory requirements in other countries
. Understanding of global drug development and the clinical trial project management process, with emphasis on investigator sites, site activation processes, patient recruitment and retention
Experience . Minimum of five years relevant clinical research experience in a pharmaceutical company/CRO, including demonstrated line management experience
. Ability to network, negotiate and liaise face to face and remotely with high level internal and external stakeholders in a professional manner
. Demonstrated strong team working and team leadership skills
. Ability to manage multiple competing priorities and projects without supervision, including strong communication, planning & organizational skills
. Ability to inspire and lead by example and motivate teams to seek solutions and get results
. Abilities to review/analyze and report relevant data so as to assist in building evidence-based clinical trial strategies
. Abilities to review analyze and report interpret protocols and regulatory documents
. Strong computer skills with an ability to understand, access and leverage technology alternatives
. A working knowledge of ICH GCP, US FDA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices.

View the original article here