Site Identification Lead - Serbia Office/ Hybrid Based

Site Identification Lead - Serbia Office/ Hybrid Based

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.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• 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. Central to this is our purpose – Driven to Deliver – which 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. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

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. 

JOB RESPONSIBILITIES 

• Ability to 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, available literature resources, etc. to identify the best suited sites for the project and proactively advocate for inclusion of strategic relationship sites with sponsor and project team as appropriate.

• Develops the Site Identification plan (Site ID checklist), with input from the Sponsor and Project Lead (PL), and by understanding the project's strategy via the feasibility workbook and Proposal document. This also includes negotiation and finalization of supporting documents such as the Confidential Disclosure Agreement (CDA) template and CDA playbook, Site ID Cover Letters, etc.

• Drafts the potential investigator feasibility questionnaire template, with input from Project Lead (PL), Medical Monitor, Clinical Lead, etc.

• Leads the technical and operational site identification aspects of global projects including tracking and weekly reporting of project deliverables to Site ID Manager, Internal Project Team, and Sponsor. Attends project team and client meetings to represent the Site Identification team and provide updates on site identification feasibility status.

• Responsible for site identification related resource management for studies including, but not limited to:

• Requesting country level resources to support projects based on scope & budget

• Communicating changes to resource requirements (change in scope) to LM’s and central resourcing team

• Provide oversight to team of local country resources for the conduct of site identification activities.

• • Project-specific financial management including, but not limited to: o Understanding costing tool & translation into activities and hours o Responsible for revenue recognition of assigned projects.

• Forecast units

• Support the PL and contract analyst in the generation of out of scope estimates for change in scope projects

• Proactive in identifying scope creep & communicating to Site ID Manager & PL.

• Able to train and mentor site identification project team members on project protocol, study-specific requirements, and the site identification process. This includes the management of performance and quality of work to meet project goals.

• Analyzes survey data and produces final site identification deliverable including site identification recommendations to PL and/or sponsor. As part of the final deliverable, you may develop assumptions for enrollment modelling and predictive analytics (e.g., for Monte Carlo Simulation).

• Ensures site identification team is updating and maintaining all project-required systems (investigator databases, trial master file, study repository, and any other project-specific tracking tool) per company and/or sponsor SOPs, processes and work instructions.

• Responsible for obtaining final site list from PL and ensuring sites are notified of non-selection decision based on results of initial site level feasibility assessment.

Qualifications

• BA/BS in the 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, as well as 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, as well as work as part of a team in a matrix environment

• Strong study-level and department-level operational experience with a willingness to challenge oneself to meet study, department, and company goals

Get to know Syneos Health

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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  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.  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.