Local Trial Manager
hace 2 semanas
**Local Trial Manager - Sponsor Dedicated.**
Primary point of contact to lead, mange and co-ordinate assigned project(s) at the country level for end-to-end project management from start-up through to closeout activities.
**Tasks & Responsibilities**:
- Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery.
- Planning, management and oversight clinical study execution in accordance with the global program strategy through leadership of the cross
- functional Local study Team (LST)
- Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
**Essentials Requirements**:
- BA/BS degree.
- Degree in a health or science related field.
- Minimum of 3 years of clinical trial project management experience in the pharmaceutical industry or CRO.
- Local knowledge/expertise of regulatory environment study start up process and associated timelines.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
- Excellent decision-making and string financial management skills.
- Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
REMOTE
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