Associate Director, Clinical Operations (Home Based - UK) - IQVIA RSS (R1099509) in Stevenage, UK at IQVIA™

Date Posted: 10/11/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Stevenage, UK
  • Experience:
    Not Specified
  • Date Posted:
    10/11/2019
  • Job ID:
    R1099509

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

IQVIA RSS has the exciting opportunity to work with a high growth, US based start-up BioMed company. Our client is looking to find an Associate Director, Clinical Operations to serve as the primary point of contact for the clinical operation aspects for designated projects and activities in the United Kingdom (UK). The Associate Director is responsible for the overall management of clinical trials conducted in the UK, and the clinical data that flows from those trials, performed under the drug development program. 

This position will be home-based and will include predominately travel within the UK but with some travel to the US.

Duties and responsibilities

  • Overall management of UK components of clinical trials within various indications and/or therapeutic areas;
  • Assists in the selection process for Contract Research Organizations (CROs) and vendors from initial RFP to contract. May attend CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals;
  • Assists in the implementation of study level processes and associated activities for the Clients UK study sites (may be across multiple indications) including investigator recruitment and selection, study-start-up, ongoing site management, subject enrollment, data collection, field monitoring, and study follow up. These activities may be managed through third-party vendors.
  • Manages multiple clinical studies and the oversight of Contract Research Organizations (CRO) and other vendors (such as central labs, central reading centers, specialty labs, cardiac core labs, etc.), with respect to activities in the UK. Responsible for ensuring that the conduct of these studies delivers against contracts and in accordance with study protocols, FDA regulations, Good Clinical Practice (GCP) Guidelines, and company timelines. 
  • Ensures clinical trial activities are progressing according to forecasted patient enrollment, treatment and follow-up plans and to implement strategies necessary to maintain trajectory of forecasted project or company deliverables.
  • Maintain regular contact with investigators and other site staff to develop collaborative relationships, and motivate the sites in a competitive trial arena, in collaboration with the assigned CRA.
  • Educate Investigators and site staff in successful enrollment techniques.
  • Support sites ion identifying and accessing recruitment pathways through referral networks, advertising, and other efforts, as appropriate for the study, country and site circumstances.
  • Leads functional work process optimization, continuous quality improvement, and change management as it pertains to clinical trial deliverables from investigative sites, data management, and monitoring.
  • Manages clinical study monitoring plans to ensure compliance with stated protocols and timely, complete and accurate receipt of clinical data from participating sites. Includes participation in direct field monitoring as needed to support the team’s field activities and to evaluate the ongoing quality of the monitoring performed by chosen vendors.
  • Partners with the Clients Quality Assurance Director to lead/support inspection readiness, audits, doing root-cause analysis, and finalize CAPAs as needed. Ensures GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across UK sites for clinical trials.
  • Works closely with the study team to support development of new clinical protocols, study plans, study reports, and clinical study strategy for the Client’s company portfolio.
  • May negotiate and approve budgets for UK investigative sites and third-party vendors.
  • Participates in conferences, Investigator Meetings, events, board meetings, and other business initiatives to promote the client in its continuous growth.

Qualifications

  • Life Sciences and/or Medical or Nursing background;
  • Minimum 10 years relevant global clinical research experience including at least 5 years as a CRA;
  • Demonstrated understanding of global biotech/pharmaceutical development environment with progressive experience at key operational levels within a Sponsor and/or CRO environment;
  • Extensive knowledge of US FDA CFR, EMA, MHRA and GCP/ICH guidelines applicable to conducting clinical trials;
  • Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring;
  • Excellent problem-solving ability, able to lay out a strategic vision for a team, detail oriented, excellent organizational skills, ability to multi-task, re-prioritize duties, and work efficiently in a face paced matrix environment;
  • Proficiency in the management and oversight of clinical monitoring duties including site monitoring, tracking, working with clinicians to ensure adherence to protocol, applicable regulatory and GCP guidelines, initiations and close out visits;
  • Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum;
  • Ability to travel up to at least 30% of time in support of clinical study activities, including international travel;
  • Excellent communication skills: oral/written/presentation
  • Strong computer skills to include MS Office: Word, Excel and PowerPoint.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1099509