Senior Site and Patient Engagement Manager - 972

Job Summary

The Senior Site and Patient Engagement Manager is a member of the Strategy & Optimization team responsible for leading the strategic planning, execution and optimization of patient recruitment and retention, overseeing/conducting pre and post award protocol, country and site feasibility assessments, and may conduct or participate in the site identification and selection process for awarded studies. This role leads and manages the process of patient recruitment strategy, end-to-end feasibility to support the business development and operational teams for assigned pre-award assessments and serves as the primary lead on post-award assessments with support from multi-functional subject matter experts. This role serves as a functional lead and subject matter expert for patient recruitment, global feasibility and site engagement. This role leads the design and implementation of patient recruitment that incorporates patient journeys, advocacy insights and indication specific needs. It directs all aspects of assigned feasibility assessments including developing feasibility questionnaires, researching/compiling site/KOL lists, driving cross-functional collaboration and feedback, compiling and assessing data analytics, inclusive of literature data mining, to produce meaningful recommendations, prepare feasibility findings report, presenting feasibility findings/recommendations to internal and external stakeholders, while meeting all time frames and targets to meet or exceed project milestones to internal and external client satisfaction.

Essential Duties and Responsibilities

• Serve as the assigned subject matter expert on patient recruitment in proposal development and on assigned projects.
• When assigned to projects, they will select, manage and oversee external vendors related to Site and Patient Recruitment (e.g. media agencies, creative teams, technology platforms, call centers, advocacy partners). Will also monitor vendor quality, deliverables, innovation and operational effectiveness.
• May serve as primary contact and project leader for specified clients for the conduct of paid feasibility assessments.
• Perform as a technical expert in Patient Recruitment and Feasibility process for internal and external clients and to provide strategic input for Business Development, Proposals, Operational Clinical Teams and Sponsors.
• May execute on paid and pre-award feasibility assessments for strategic and/or key accounts and others as assigned.
• Expertly mine, review, dissect and interpret clinical trial business intelligence information, data analytics, site reported data, literature and systems in various formats to apply to individual assessments, drive multi-functional discussion and derive recommendations related to protocol, country, trial design, accrual rate and site components of assigned assessments.
• Applies project management methodology, leadership and problem-solving skills to pre and post award feasibility assessments to support project level objectives, goals and deliverables.
• Establish and maintain trustful relation with client(s) by consistently delivering high quality and reliable feasibility related services to specified client(s) within agreed upon timelines.
• Provide study and patient recruitment related protocol and country considerations and guidance to internal and external teams and for department-wide pre and post award feasibility assessments.
• Confidently facilitate discussions and presentations amongst cross functional areas, Executives, Sponsor team members, Key Opinion Leaders and site staff to obtain necessary information, goals, feedback and opinions related to assigned feasibility assessments.
• Review and understand study documents and prepare summaries for teams involved in patient recruitment and feasibility activities.
• Data mine and review scientific literature and conduct self-training pertinent to patient recruitment and feasibility activities.
• Explore and understand indication specific advocacy and social patient environment to integrate strategies and data into patient recruitment strategies and feasibility assessments from unique or patient-driven forums.
• Develop feasibility assessment questionnaires, input into survey tools, assess data and collate to develop meaningful metrics to drive recommendations and decisions for study execution and/or site identification.
• May lead or conduct identifying and selecting investigators and sites for clinical trial participation. This may include developing a project specific plan related to the Site ID process.
• Author feasibility findings reports and presentations as primary delivery and serve as primary presenter, with the ability to communicate clearly in both written and oral format, to Sponsor and other applicable audiences.
• Support, facilitate and engage with sites and PIs within and outside of site networks to encourage continued support, engagement and feedback for future assessments and potential study execution.
• Routine assessment of project financials and monthly review of invoices, when applicable.
• Participate and/or manage other assigned activities to enhance feasibility, patient recruitment, and site engagement offering, processes and overall Advanced Clinical mission.
• Adhere to strict code of confidentiality as it relates to study subjects, sponsors, physicians and policies and procedures.
• May develop, prepare/attend preparation meetings, and deliver bid defense presentations to clients and stakeholders during Bid Defense Meetings.

Qualifications

• BS or BA degree in life sciences, business or healthcare field or equivalent combination of education and experience.
• Minimum 7 years of professional experience in Clinical research and/or Drug Development. Experience should include working knowledge of study management logistics, medical management and protocol design, regulatory/start-up logistics, trial design, country-level nuances and robust protocol, country and site feasibility assessment conduct. Experience within a CRO and/or the feasibility space is a plus
  
  
  
  • In-depth knowledge regarding the drug development process, operational conduct processes and challenges within clinical research.
  • Knowledge of frequently utilized feasibility and business intelligence systems in the clinical trial industry.
  • Expertise in internal and external relationship management.
  • Inquisitive in nature, enjoys researching to uncover what may not be readily available and detailed orientated.
  • Must be able to see the "big picture" and project manage to the detail.
  • Excellent communication and presentation skills, including written, spoken and listening skills.
  • Demonstrated ability to work in a fast-paced environment.
  • Demonstrated ability to lead cross-functional teams, including those that are of higher seniority.
  • Must have a positive demeanor with strong problem analytic and problem solving skills.
  • Must have exceptional time management skills and the ability to work with individuals across various levels of the organization, as well as individuals across all levels outside of the organization.
  • Consultative and collaborative approach when working with internal and external customers.
  • Ability to transparently and clearly communicate with internal and external stakeholders to ensure project milestones and goals are achieved.
  • Ability to effectively coordinate and successfully manage feasibility assessment activities and weave resulting strategy into a customized solution response to meet the needs of Advanced Clinical's customers within agreed timelines.
  • Computer skills, including at least intermediate proficiency of the use of Microsoft products, but specifically Power Point, Excel and frequently utilized business intelligence tools (i.e. Citeline, Claims Databases, Impact Assessment Tools, TrialHub, etc.)
  
  

This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).