DirecciónDuties and Responsibilities :
- Provide country / regional operational insight into site feasibility and selection and overall patient recruitment strategy
- Participate in Clinical Study Team Meetings and Quality Review Meetings where necessary providing input to study teams on operational issues based on site visits and contacts
- Attend and present at investigator meetings, monitor workshops / training
- Participate in site visits with investigator site staff and / or CRO representatives, or independently, in support of Clinical Trial execution and report back to study teams e.
g. feasibility, startup activities, enrolment or escalated study / site issues
- Responsible for review, documentation and follow up of investigator site issues including tracking metrics
- Provides sponsor regional operational support and acts as point of escalation for investigator sites as appropriate
- Participate in Regulatory GCP inspections and / or audits at investigator sites as sponsor representative
- Complete all administrative responsibilities consistent with SOPs and departmental guidelines including but not limited to required training, field activity documentation, expense reporting, and other assigned tasks
- Manage travel and local expenses in accordance with sponsor and TMAC policies
Qualifications and Experience :
- Minimum Bachelor’s degree, master’s preferred or terminal degree (MD, PhD or PharmD)
- 8+ years relevant industry and / or CRO experience required
- CTL experience preferred
- Extensive experience in global Clinical Trial operations required
- Oncology Clinical Trial experience
- Extensive medical and scientific knowledge and clinical development understanding
- Excellent communicator of technical and scientific information
- Excellent interpersonal skills and demonstrated collaborative as well as independent working style
- Ability to build relations with the external medical community
- Proactive and self-motivated, ability to align activities with the clinical development plans (CDPs)
- Strong organizational skills with effective use of time and prioritization
- Cross cultural awareness
- Fluency in English and in local language in country of residence required
- A working knowledge of ICH / GCP
- Computer skills including Excel, Word, and PowerPoint
- A willingness to travel frequently within assigned geographical territory, including overnight travel.
- Valid driver’s license
Hace 2 horas
