The individual in this position brings a high level of experience and will be a major contributor in the support of managing large, outsourced, global and domestic clinical trials in multiple phases, from study start up to close-out; in a dynamic, growing, fast-paced environment. This position requires taking a proactive stance, working well in a team environment, and communicating effectively with both internal and outsourced transnational teams.
- Assist in managing clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
- Perform the activities of planning, implementing, motivating, co-monitoring, managing, and tracking clinical trials.
- Assist in the supervision of field monitors, and Contract Research Organizations.
- Establish effective relationships with clinical investigators and staff, CROs, and vendors.
- Monitor sites and ensure compliance with protocols and overall clinical objectives.
- Participate in the design and development of clinical trial protocols, case report forms, and study documentation.
- Contributes to clinical operations department development and infrastructure.
- Work proactively with data management to identify and resolve data discrepancies.
- Leads internal and external development of key study documents including, but not limited to study procedure manuals and project tools, monitoring plans and informed consents.
- Evaluates, manages, and facilitates the timely flow of clinical data to support program objectives.
- Oversee forecasts to maintain sufficient clinical and non-clinical supplies.
- Maintains frequent contact with and works effectively with study stakeholders including investigators, vendors, and internal staff.
- Provides guidance, clinical trial management expertise, and direction to study team members.
- Six or more years of relevant experience in clinical development, including at least 3 years of experience as an in-house Clinical Research Associate.
- Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations.
- Prior experience with infectious disease trials a plus.
- Requires a Bachelor’s Degree in a scientific discipline.
- MS/PhD/RN in a scientific discipline is a plus
Preferred Additional Skills:
- Proficient with Microsoft Office.
- Prior experience implementing clinical systems (EDC, IXRS).
- Cross-functional leadership to facilitate team meetings and drive study progress.
- Experience developing study execution strategies, risk mitigation, and successful site/country selection.
- Ability to work independently.
- Outstanding written and verbal communication skills.
- Extensive knowledge of clinical study methods and cross-functional needs.
- Ability to multi-task as needed in a start-up environment.
- Able to travel up to 15% (international and domestic travelrequired).
- Committed to the values of integrity, accountability, transparency, scientific rigor and drive.