Real World Evidence Site Management Lead (R1023415) in Sao Paulo, Brazil at IQVIA™

Date Posted: 5/2/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    5/2/2018
  • Job ID:
    R1023415

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.


Background

Clinical research is a branch of health science that determines the safety and efficacy of drugs, devices, diagnostic products and treatment schemes intended for human use. These can be used for prevention, treatment, diagnosis or to alleviate symptoms of a disease. Patient Safety, Data Integrity and Operational Excellence are central pillars for us. Having said that we are looking for Site Management Leader (SML) who will be assigned at the beginning of the study and has operational leadership / oversight of all site management operations, from site ID to study closure. The SML will ensures overall project efficiency and adherence to project financial timetables and targets; reporting metrics and activities out of scope. Also, will Develop, implement and maintain Site Recruitment, Operational Risk Management Plans, etc.


General Responsibilities:

  • Oversee the delivery of Site Management project tasks, providing advice and guidance to help achieve high performance and quality project deliverables.
  • Develop, implement and maintain the Site Recruitment, SPS Operations and SPS Risk Management Plans within the agreed project strategy.
  • Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.
  • Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
  • Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to appropriate SPS management and project management leaders.
  • Conduct co-monitoring and/or assessment visits to ensure the study is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.
  • Develop and deliver presentations/training to clients, colleagues and professional bodies, as required.
  • The SML lead the team of Site Managers (in-house CRAs) and CRAs.
  • The Site Managers take the sites from a selected status and work to get them initiated including collection of reg docs, contract and budget negotiations through SIV (if remote). Following the SIV, the Site Managers are the primary point of contact for the sites and are responsible for the daily site management and in-house monitoring activities
  • The CRAs are for onsite monitoring only. Since many studies have limited onsite monitoring, they may be assigned to multiple studies
  • Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables.
  • Develop strategies to ensure the timely selection and start up of sites and ensure sites are opened to enrollmentin a timely manner. 
  • Oversee site recruitment activities and collaborate with other functional groups to ensure study recruitment targets are met.
  • Develop, implement and maintain the Site Recruitment, Operations Risk Management Plans, etc.
  • Develop all study operational tools, guides for site managing, monitoring and query resolution/site facing
  • Counterpart to Project Manager – (does not report to PM)
  • Act as the first line of escalation for site management questions and issues on assigned projects.
  • Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
  • Participate in business development activities such as proposal development and bid defenses.
  • May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.

Qualifications:

The SML possesses the following qualifications:

  • Fluent English
  • Strong leadership skills
  • Project Managers and Site Management/Clinical Leads from other CROs or Sponsors
  • CRAs and in house Site Managers with direct leadership experience.
  • Experience with Other Functional Leads (Example: Data Management Leads, RSU Leads, CEVA Leads, Site ID Leads, etc.)
  • Project Managers/Project Leads
  • Clinical Leads


We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™


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Job ID: R1023415