Clinical Manager ofertas em United States

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 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 years of local trial management or mutually agreed clinical trial experience.
• Fluent both in Arabic and English.