inVentiv Health Sr. Study Start Up Specialist (Sr SSU) | Singapore in Singapore, Singapore

Organization Overview Organization Overview inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.

Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients’ therapies to market.

Title Sr. Study Start Up Specialist (Sr SSU) | Singapore

Job ID 12840



  • Conducting research local requirements for documentation of IRB/EC submission approvals, and subsequent follow-up documentation and providing updates of local processes and requirements to the Regulatory Intelligence portal

  • Liaising with study sites regarding essential document collection and assisting with IRB/EC submissions as required

  • Customizing country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents as required, e.g., patient-directed materials

  • Completing review of essential documents following Essential Document Checklist QC

  • Arranging/reviewing translations of regulatory documents as required

  • Providing regular local status updates to SSU Project Lead; updating appropriate study-tracking tools with local essential document and ethics committee status, and maintaining project tracking systems as required for assigned projects

  • Ensuring all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements

  • Assisting the Feasibility Group with conduction of feasibility studies and assisting project teams with site selection activities, as required

  • Supporting the Grants and Contracts group with contract and budget negotiation, as required

  • Identifying site issues during Start-up process, resolving minor to moderate issues independently, and escalating and participating in the resolution of complex issues

  • Training/Mentoring junior SS on local regulations, internal procedures

  • Supporting the development of Start-Up Plans and Essential Document Checklists

  • Leading a single-country/domestic study, providing work direction and oversight to a team

  • Playing the role of SSU Project Lead on projects with limited scope in terms of regions/size

  • Completing assigned training programs and applying learning

  • Performing necessary administrative functions (e.g. submission of expense reports, entering time)

  • Any other activities as required to achieve business needs



  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

  • Five years clinical research/monitoring experience including 4 years study start-up experience

  • Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information

  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

  • Strong communication, interpersonal, and organizational skills

  • Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located

  • Ability to work independently in a fast-paced environment

  • Must demonstrate excellent computer skills

  • Experience in completing successfully (quality and time) start-up of studies in the relevant country including interactions with Regulatory and Grants and Contracts

  • Demonstrate leadership and project management skills

  • Position requires a minimum of 20% travel

City Singapore

Country Singapore [SG]