This position is responsible for providing oversight of Phase 1 to Phase 4 clinical trial implementation; ensuring clinical studies are conducted in a timely manner with milestones being achieved within budget.
- Utilize Project Management techniques and methodologies to plan, organize, monitor, conduct, report and complete clinical programs/studies within budget expectations and on-time, and use the same to alert senior management of any deviations in a timely manner.
- Partners with appropriate team members and functional areas to obtain appropriate program support and resolve issues and/or plan contingencies impacting program strategy and operations.
- Lead and train clinical sites, in house and partner/CRO personnel to ensure that clinical trials are conducted according to the timelines and budget.
- Communicate regularly with Investigators, Site and CRO personnel to ensure compliance with protocols, federal and industry-accepted regulations and proper data collection and reporting.
- Ongoing communication with vendors and clinical sites to ensure data integrity
- Manage external vendors, including CROs and specialty laboratories.
- Prepare and review protocols, amendments, consent forms, case report forms, and other trial related documents.
- Co-monitor activities at clinical study sites (when necessary).
- Prepare clinical portions of regulatory documents as required.
- Self-motivated; must have initiative
- Demonstrate experience leading interdisciplinary development teams is required. Ability to communicate/negotiate effectively in a team environment
- Ability to multi-task and prioritize projects
- Strong knowledge of ICH/GCP, FDA regulations
- A working knowledge of basic financial accounting is preferred but not required.
- Proficient computer skills and good working knowledge of MS Word, Excel, PowerPoint and Project are required.
- Excellent oral and written communication and interpersonal skills are essential with fluency in English
Education & Experience:
- Requires a BS with a minimum of 8 years relevant experience in a clinical research with at least 2 years managing clinical research studies (i.e., pharmaceutical, CRO, academic research or biotechnology environment). A strong background in drug development ideally with experience in Clinical Research, Clinical Operations, or Life Sciences functions is important.
- Project Management experience: Must have strong Project Management experience for the Clinical Operations activities involved with planning, managing, executing and closing multiple and concurrent clinical studies (domestic and international) in various phases of both early and late stage clinical development (i.e. Phases I, II and III). Project Management Professional (PMP) Certification is highly desired.
- Communication, management and negotiation skills: Must have strong skills and proven accomplishments in all of these areas