SSU Project Delivery Lead - Europe

Employer
Syneos Health
Location
Europe
Salary
Not available
Closing date
19 Sep 2020

View more

Discipline
Clinical Research, Study Start Up, Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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JOB SUMMARY

 

Responsible and accountable for the customer-focused leadership and management of Site Start-Up (SSU) deliverables within a region or globally, within the assigned projects or programs.  Directs the technical and operational aspects of the Site Start-Up deliverables of the assigned projects.   Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations.  Responsible for overseeing all Site Start-Up activities from site selection/recommendation through site-activation ready.  Develops integrated SSU timelines and reports weekly progress including plans to address potential risks/gaps to the project team, Project Manager (PM), SSU Management and Project Sponsor.

 

JOB RESPONSIBILTIES

 

  • Collaborates with major functional area leads (SSU Country Managers, Project Management, Clinical Management,) to identify and evaluate fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented.  Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.

 

  • Develops and maintains relationships with customers in alignment with their assigned projects. May collaborate with business leads for business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals.  Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.  Contributes to change initiatives across and within the SSU department.

 

  • Provides oversight of all project SSU deliverables which encompasses all activities from site selection through site activation ready.

 

  • Assumes accountability on SSU deliverables including, but not limited to:

 

  • Start-up regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export  licenses, study maintenance submissions);
  • Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites
  • Establishing Essential document collection leading to site activation;
  • Overall SSU timelines to site activation.

 

  • Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes.  Complies all controlled document requirements and other requirements to ensure quality deliverables.

 

  • Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.

 

  • Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team.

 

  • Reviews the project SSU budget with the functional leads, PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability.  Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations.

 

  • Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures minimum hours are used for tasks.  If out-of-scope work is requested, notifies the PM and SSU Manager and tracks out-of-scope work until it is assigned to back log.

 

  • Prepares the core submission documents and core clinical trial application dossier. 

 

  • Assists in development of master Patient Information Sheet (PIS) /Informed Consent Form (ICF) in collaboration with the PM and medical department.

 

  • Oversees collation, quality review, and submission of country-specific applications.

 

  • Accountable for the timely follow-up for Ethics Committee/Competent Authority enquiries or objections in collaboration with the country SSU Specialists.  Meets or exceeds the planned submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, solves or escalates the problem quickly.

 

  • Accountable for the oversight of negotiation and execution of clinical trial agreements and budgets in accordance with agreed timelines. Includes coordination of internal and external stakeholders in the development and/or provision of required clinical trial agreement templates and investigator site budgets, oversight of local contract negotiator colleagues and assistance in resolving negotiation barriers, and periodic progress reporting to the client and other stakeholder groups.

 

  • Identifies best practices and participates in process improvement initiatives in conjunction with the global SSU leadership plan and project deliverables.

 

  • Participates in new business development activities including participation at client presentations.  Provides information to support business development activities.

 

Other Responsibilities:

 

  • Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

 

  • Performs other work-related duties as assigned.  Minimal travel may be required (up to 25%).

 

 

QUALIFICATION & REQUIREMENTS

 

  • Bachelor’s Degree, Higher Degree Preferred. Minimum 4 years CRO industry experience and/or a minimum 3 years’ experience working in a SSU, or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.

 

  • Experience with leading/co-leading at least 5 studies from award and into maintenance; at least 2 of those studies must have included more than 10 countries across multiple regions.

 

  • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP Good understanding clinical protocols and associated study specifications. Excellent understanding of clinical trial start-up processes. Project management experience in a fast-paced environment.  Good vendor management skills Strong organizational skills with proven ability to handle multiple projects. Excellent communication, presentation and interpersonal skills. Quality-driven in all managed activities. Strong negotiating skills. Strong problem-solving skills.  Demonstrate an ability to provide quality feedback and guidance to peers Contribute to a training and Quality assurance plan within SSU and update SOPs/WI.

 

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.  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.

Syneos-header

Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit syneoshealth.com.

Please visit our Careers Hub on PharmiWeb.Jobs:www.pharmiweb.jobs/minisites/syneos-careers-hub/

Contact Us
  • Corporate Headquarters
  • 3201 Beechleaf Court
  • Morrisville
  • 27560
  • US
  • +1 919 844 7100
  • Mini-site: Syneos Health
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