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About the Role
Acts as primary contact and team leader for the site identification process for awarded or ongoing trials and/or standalone feasibility projects. Manages all Site Identification activities to ensure quality, on time deliverables that are within budget.
Responsibilities
- Understand and translate protocol requirements to develop the ideal site profile in collaboration with Sponsor and key cross-functional leads.
- Mine relevant databases, epidemiology resources, and literature to identify suitable sites.
- Proactively advocate for the inclusion of strategic relationship sites with sponsor and project team.
- Develop the Site Identification plan, including negotiation and finalization of supporting documents.
- Draft the potential investigator feasibility questionnaire template.
- Lead the technical and operational site identification aspects of global projects.
- Track and report project deliverables to Site ID Manager, Internal Project Team, and Sponsor.
- Attend project team and client meetings to represent the Site Identification team and provide updates.
- Manage site identification related resource requirements for studies.
- Communicate changes to resource requirements to LM’s and central resourcing team.
- Provide oversight to local country resources for site identification activities.
- Manage project-specific financials, including understanding costing tools, revenue recognition, and forecasting units.
- Support the generation of out-of-scope estimates for change in scope projects.
- Proactively identify scope creep and communicate to Site ID Manager & PL.
- Train and mentor site identification project team members on project protocol, study-specific requirements, and the site identification process.
- Manage performance and quality of work to meet project goals.
- Analyze survey data and produce final site identification deliverables, including recommendations.
- Develop assumptions for enrollment modelling and predictive analytics.
- Ensure the site identification team updates and maintains all project-required systems per company and/or sponsor SOPs.
- Obtain the final site list from PL and ensure sites are notified of non-selection decisions.
Requirements
- BA/BS in biological sciences or related discipline in the natural sciences/health care field (e.g. RN).
- Experience working in a pharmaceutical, biotech, contract research organization or clinical research site.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, database applications), email, and internet.
- Strong presentation skills, interpersonal skills, and a team-oriented approach.
- Excellent verbal, written, communication and time management skills.
- Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high-quality work.
- Ability to be flexible, adapt to change, work independently, and work as part of a team in a matrix environment.
- Strong study-level and department-level operational experience.
- Willingness to challenge oneself to meet study, department, and company goals.
Skills
- Site Identification
- Protocol Interpretation
- Database Mining
- Feasibility Planning
- Confidential Disclosure Agreement (CDA) Management
- Investigator Feasibility Questionnaires
- Project Tracking and Reporting
- Client Meetings
- Resource Management
- Financial Management
- Scope Creep Identification
- Team Training and Mentoring
- Performance Management
- Data Analysis
- Enrollment Modelling
- Predictive Analytics
- System Maintenance
- Microsoft Office Suite
- Presentation Skills
- Interpersonal Skills
- Teamwork
- Communication Skills
- Time Management
- Multitasking
- Attention to Detail
- Flexibility
- Adaptability
- Independent Work
- Matrix Environment Navigation
Education Level
- BA/BS in biological sciences or related discipline in the natural sciences/health care field (e.g. RN)
About the Company
- Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
- We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
- Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
- Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
- We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself.
- Our purpose – Driven to Deliver – captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
- We are continuously building the company we all want to work for and our customers want to work with.
- We shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
- Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
- Take the initiative and challenge the status quo in a highly competitive and ever-changing environment.
Equal Opportunity
- The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
- Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.