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Clinical Project Manager/ Assoc Clinical Project Manager Sponsor-dedicated
2 weeks ago
**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 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.
