Site ID Lead

1 semana atrás


São Paulo, São Paulo, Brasil Syneos Health Tempo inteiro
Overview

Site ID Lead - Argentina, Brazil or Mexico Home Based. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model places the customer and the patient at the center of everything we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers to help our customers achieve their goals. Syneos Health employs 29,000 people across 110 countries.

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, 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, 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 and budget; communicating changes to resource requirements to line managers and central resourcing teams; providing oversight to a team of local country resources for the conduct of site identification activities.
  • Project-specific financial management including, but not limited to: understanding costing tool and translation into activities and hours; responsible for revenue recognition of assigned projects; forecasting units; supporting the Project Lead and contract analyst in the generation of out of scope estimates for change in scope projects; proactively identifying scope creep and communicating to Site ID Manager and PL.
  • Able to train and mentor site identification project team members on project protocol, study-specific requirements, and the site identification process. This includes management of performance and quality of work to meet project goals.
  • Analyzes survey data and produces final site identification deliverables including site identification recommendations to PL and/or sponsor. As part of final deliverable, may develop assumptions for enrolment modelling and predictive analytics (e.g. Monte Carlo Simulation).
  • Ensures site identification team updates and maintains all project-required systems (investigator databases, trial master file, study repository, and any other project-specific tracking tool) per company and sponsor SOPs, processes and work instructions.
  • Responsible for obtaining final site list from PL and ensuring sites are notified of non-selection decisions 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, 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, 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.

Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its discretion. The Company is committed to compliance with applicable laws and policies, including reasonable accommodations under applicable statutes. The content herein is intended to comply with obligations of the jurisdictions where the company operates.

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