Acts as primary contact and team leader for the site identification and the site selection 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.
1.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.
2.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 Clinical informatics 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.
3.Drafts the potential investigator feasibility questionnaires with input from Project Lead (PL), Medical Monitor, Clinical Lead, etc.
4.Leads the technical and operational site access aspects of global projects including tracking and weekly reporting of project deliverables to Line Manager (LM), Internal Project Team, and Sponsor. Attends project team and client meetings to represent the Site Access team and provide updates on site identification feasibility status.
5.Responsible for site access related resource management for studies including, but not limited to:
a)Requesting country level resources to support projects based on scope & budget
b)Communicating changes to resource requirements (change in scope) to LM’s
c)Provide oversight to team of local country resources for the conduct of site identification activities.
6.Project-specific financial management including, but not limited to:
a)Understanding costing tool & translation into activities and hours
b)Responsible for revenue recognition of assigned projects
d)Generate cost estimates using costing tool for change in scope projects
e)Proactive in identifying scope creep & communicating to LM & PM.
7.Able to train and mentor site access 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.
8.Analyses survey data and produces final site access deliverable including site access recommendations to PL and/or sponsor. As part of final deliverable, develops assumptions for enrolment modelling and predictive analytics (e.g. for Monte Carlo Simulation).
9.Supports the development of relevant information libraries and communication materials to assist with RFI/RFP development and queries from Sponsors, Business Development and project teams.
10.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.
11.Responsible for obtaining final site list from PL and ensuring sites are notified of non-selection decision based on results of initial feasibility assessment.
12.May oversees performance and issue management of studies running at key strategic sites in the role of a site relationship manager.
QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)
•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 track record of leadership and a willingness to challenge oneself to meet study, department, and company goals
This job excludes Colorado applicants
:North America - US Home-Based
:Europe - SRB-Client-Based, Latin America - MEX-Home-Based, North America - CAN-Home-Based, Latin America - ARG-Home-Based
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