Regulatory & Start Up Specialist 2 (R1054757) in Reading, UK bei IQVIA™

Datum der Veröffentlichung 10/3/2019

Stellenauszug

  • Mitarbeiterkategorie:
    Vollzeitbeschäftigung
  • Standort:
    Reading, UK
  • Berufserfahrung:
    Not Specified
  • Datum der Veröffentlichung
    10/3/2019
  • Job ID:
    R1054757

Stellenbeschreibung

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.

We are looking to grow our UK RSU Team based in Reading. We are looking for Regulatory & Start Up Specialist 1 & 2 as well as a Senior Regulatory & Start Up Specialist.

RESPONSIBILITIES

• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. Where applicable, act as a Country Lead for projects with no regional Lead assigned.

• Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.

• Prepare site regulatory documents, reviewing for completeness and accuracy.

• Review, prepare and negotiate site contracts and budgets with sites, if applicable.

• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.

• Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.

• Review and provide feedback to management on site performance metrics.

• Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.

• May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.

• May assist in pre-award activities including bid defenses, proposals and oversights of the scope of work at country level.

• May provide input into contract and budget template development.

• May support importation activities.

• May have direct contact with sponsors on specific initiatives.

• May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF.

• May act as mentor, and prepare and deliver country-specific training, for less experienced staff

• May participate in feasibility and/or site identification activities.

• May perform Site Selection Visits if a trained monitor.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• In-depth knowledge of clinical systems, procedures, and corporate standards.

• Good negotiating and communication skills with ability to challenge, if applicable.

• Effective communication, organizational, and interpersonal skills.

• Ability to work independently and to effectively prioritize tasks.

• Ability to manage multiple projects.

• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.

• Understanding of regulated clinical trial environment and knowledge of drug development process.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.

PHYSICAL REQUIREMENTS

• Extensive use of keyboard requiring repetitive motion of fingers.

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

• Regular sitting for extended periods of time.

• May require occasional travel.

What We Offer / USPs

  • We invest in keeping our teams stable so workload is consistent
  • We offer genuine career development opportunities for those who want to grow as part of the organisation
  • The chance to work on cutting edge medicines right at the forefront of new medicines development
  • IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. Next generation clinical development!
  • As a CRA you will receive an iPad and use of key developments such as site visit app’s, site visit report app’s that allow CRA’s to do their day job more efficiently.

Awards

  • FORTUNE Magazine's World's Most Admired Companies list for the third year in a row.
  • Recognised by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO).
  • Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year. A site-nominated award recognising contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity.
  • IQVIA named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.

IQVIA is an equal opportunity employer. We make employment decisions based on qualifications and merit. We prohibit discrimination based on any unlawful consideration such as age, race, national origin, gender or other "protected status."

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 ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1054757