Seeking a Clinical Trials Project Specialist for our Medical Affairs department. This position has the opportunity to work remote.
The Clinical Project Specialist is accountable for the achievement of key functional business objectives, and oversight of key activities in a platform or program area. The Clinical Trials Project Specialist demonstrates understanding of advanced technical/scientific principles applicable to the platform/program area of focus and those of associated disciplines (such as R&D, Quality, Business, or Project Management). This also includes representing Medical Affairs (MA)/Clinical Operations on Core Teams/Product Development Teams for existing and/or new product initiatives.
- Generating clinical evidence plans to include publication strategies.
- Coordinate and lead the team through journal publications and scientific conference presentations and represent Medical Affairs in market development activities
- Creates coherent, professional documentation and correspondence of moderate complexity with the ability to draw conclusions from primary and other written and/or verbal sources, present, and or act on them effectively.
- Develops and prepares training materials consistent with technical and stylistic input from more senior associates.
- Creates and delivers moderately complex presentations to primarily internal audiences; and respond to questions extemporaneously.
- Recognizes potential problems and takes preventive steps.
- Recommends solutions for more complicated or ambiguous issues for consideration.
- Identifies possible process improvement opportunities and makes recommendations for the team to implement solutions that will impact on quality, cost, and/or productivity and provide supporting data for a formal budget process.
- Participates in CI initiative in own or related area of responsibility.
- Manages multiple complex or multi-stage projects.
- Serve as a mentor/coach for Project Management principles, tools, and processes.
- Provides updates to leadership involving, periodic updates on activities, discussion of issues, proposals for resolution.
- Fosters collaboration among team members and is a leader within function or business unit.
- Contributes to short term planning and decisions for groups and/or projects.
- Estimates resources required and works with manager to ensure availability of required supplies and/or resources for individual and/or group activities.
- Review and provide input to product labeling and Health Hazard Evaluations.
- Contact external KOLs regarding trends in clinical practice and potential impact of product issues.
- Qualifications: Bachelor’s degree required, with preferred education/experience focus Molecular Biology, Clinical Microbiology, the life sciences, clinical, laboratory or other relevant technical areas. Professional certification (clinical research, laboratory) preferred.
Base Salary - up to $117,800
2+ to 5 years experience
Seniority Level - Mid-Senior
Minimum Education - Bachelor's Degree