Sr Patient Engage Specialist

INC Research Inc Morrisville , NC 27560

Posted 5 months ago


Key supportive role on the Patient Engagement team ensuring that all project deliverables meet the client's (Syneos project teams, Sponsor) expectations and the contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.

1.Manages the development, preparation, approval and distribution of materials relating to Patient Engagement tactics from sponsor contracting through to closure of Patient Engagement activities.
2.Responsible for tracking and reporting of program metrics and management of all recruitment campaigns.
3.Collaborates with study team to define and lead site level activities, including, but not limited to following up with site staff to obtain metrics via applicable systems plus independently resolve any site issues that arise.
4.Acts as main POC for Patient Engagement, communicating with client to provide timely project updates and project related fiscal information. May collaborate with contracts and proposals development, project management, and clinical management to achieve contractual and financial project goals within specified timelines and high quality.
5.Conduct initial development of the Patient Engagement Plan and takes responsibility for maintaining all subsequent updates as per scope of work plus identify risks and recommend contingencies per indication.
6.Proactive planning and submission of all patient recruitment materials to Regulatory/Ethics Committee/Ministry of Health and approvals with the regulatory leads for national and global studies. Ensures accurate documentation of approved material versions are acquired prior to proceeding with next steps of the development process.
7.Trains external vendor teams on project/protocol specific requirements so these teams can provide adequate support and coverage to projects.
8.Manage project within contracted direct/indirect budgets and timeline ensuring any out of scope activities are not initiated prior to being documented via budget update, communicated to the project management team and approved by the sponsor. Makes recommendations to assist with PE related change orders for assigned projects.
9.Contributes to change initiatives across and within the Site & Patient Access Business Unit.

QUALIFICATION REQUIREMENTS (please indicate if 'preferred')

  • BA/BS in the biological sciences or related discipline in the natural sciences/health care

  • 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

  • Bilingual skills preferred

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Project Specialist (Morrisville NC Office)

INC Research Inc

Posted 1 week ago

VIEW JOBS 10/9/2019 12:00:00 AM 2020-01-07T00:00 JOB SUMMARY The Senior Project Specialist is responsible for maintaining and coordinating the logistical aspects of clinical projects, and provides overall support to functional leads to ensure the successful completion of project deliverables The Senior Project Specialists supports the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers' requirements. Operate independently, with minimal day to day oversight, and may co-ordinate the activities of Project Specialists JOB RESPONSIBILITIES * Set-up, maintain and close out project files and study information ((e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems. * Maintain and distribute study-specific /financial reports (e.g. vendor/site invoices, investigator payments (grants and pass-through), forecasts, etc). * May lead internal and external meetings as directed by the PL Prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure. * Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PL. Assesses and communicates KPIs for associated job tasks to PL with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PL * Ensure all study documents are archived based on the appropriate guidelines and policy. * May serve as project representative for internal and external audits. Provide support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution actionable issues. * May serve as primary customer contact when PL is out of the office. Seeks input from Project Director for customer support. * May mentor and train Project Specialists QUALIFICATION REQUIREMENTS * Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience * Moderate relevant clinical research experience with an understanding of clinical drug development and clinical trial operations. Experience in a therapeutic group preferred. * Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements * Strong organizational skills. * Ability to perform several tasks simultaneously to meet deadlines. Self-motivation and ability to work independently. . * High proficiency with full MS Office Applications * Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade * Ability to travel if necessary preferred (approximately 5%) * High level of competence in English language Disclaimer: 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. INC Research Inc Morrisville NC

Sr Patient Engage Specialist

INC Research Inc