Job Overview:
Local Clinical Project Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Site Manager (SM) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.
Deliverables:
- Services rendered will adhere to applicable sponsor’s SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
- Complies with relevant training requirements.
- Contribute to quality Site Selection
- Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget
- Act as primary contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
- Drive study compliance
- Contribute to site level recruitment strategy and contingency
- Delivers competent vendor management at the country level
- Ensures high standards for study monitoring
- Contributes to patient understanding of protocol and patient safety
- Ensures trial subject safety
- Ensures Inspection readiness
- Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge enough for role and responsibilities.
- With focus on quality and compliance, will work closely with SM to ensure CAPA is implemented for audits/inspections or any quality related visits. May conduct accompanied site visits with SM, if delegated by FM.
- Ensure accurate finance reporting and trial delivered within budget
- Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start Up team, if as applicable.
- May contribute as a trainer of systems/processes or provide input to functional area in process initiatives, if applicable.
- Full utilization by timely and accurate time reporting.
- Experience in management and startup of complex Early Phase trials projection with internal matrix clinical teams and sites, as applicable.
Education and Experience Requirements:
- BA/BS degree.
- Degree in a health or science related field.
- More than 2-3 years of local trial management or mutually agreed clinical trial experience in Oncology.
- Experience in Immunology is preferred.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com