Description
Syneos Health is seeking a HGRAC II professional to join their team in Beijing or Shanghai. The successful candidate will be responsible for ensuring quality deliverables at the country level, following project requirements and applicable country rules.
Responsibilities:
- Ensure quality deliverables at the country level, following project requirements and applicable country rules
- Monitor basic financial aspects of the project and escalate discrepancies in a timely fashion
- Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner
- Support continuous improvement of quality in all Site Start-Up (SSU) components at the country level
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
- Act as a point of contact for the PM/SAM (or designee) during start-up on allocated projects
- Prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required
- May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues
- Oversee site activation end to end process at country/site level
- Provide support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies
- May be asked to perform Local Investigator Contract and Budget Negotiator tasks
Qualifications:
- Bachelor's Degree
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
- Ability to understand clinical protocols and associated study specifications
- Detailed understanding of clinical trial start-up processes
- Ability to manage external vendors to contract effectively
- Strong organizational skills with ability to handle multiple tasks effectively
- Strong written and verbal communication and interpersonal skills
- Ability to manage multiple project budgets with increased complexity and value
- Quality-driven in all managed activities
- Good negotiating skills
- Good problem-solving skills
- Demonstrated ability to work independently as well as part of a team