Sr Clinical Trial Manager - Dermatology (Home-based, UK/Europe) - IQVIA Biotech (R1092506) in Stevenage, UK at IQVIA™

Date Posted: 9/16/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Stevenage, UK
  • Experience:
    Not Specified
  • Date Posted:
    9/16/2019
  • Job ID:
    R1092506

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 Biotech has vacancies for Clinical Trial Managers to be home based in the UK or EU.

BASIC FUNCTIONS:

Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities.  Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial.  Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Responsible for all activities related to implementation and execution of clinical studies that include:

  • Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope.
  • Serve as client advocate within IQVIA Biotech
  • Develop and implement Clinical Monitoring Plan.
  • Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:
  • Coordinate site management activities
  • Site identification, recruitment, and selection
  • Regulatory document collection and review
  • Overall scheduling and management of all site visits
  • Develop site/monitoring tools and training materials
  • Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions
  • Set and enforce project timelines with the assigned study team
  • Coordinate remote review of clinical data within EDC system
  • Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract
  • Review and approve trip reports and follow-up letters within required timeframe
  • Schedule and manage weekly CRA project team meetings
  • Ensure CRAs assigned to team receive therapeutic and project-specific training
  • Manage quality and regulatory compliance among clinical monitoring team and investigational sites
  • Attend and provide information at monthly projections meetings
  • Attend and provide information at weekly client teleconferences/team meetings
  • Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization
  • Define and implement functional standards, goals, and expectations with clinical monitoring team.
  • Serve as CRA mentor and perform accompanied field assessment visits as required
  • Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA
  • Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions
  • Define the scope of work with the client and clinical monitoring team
  • Assist PM in identifying and generating changes in scope and notify client of potential changes in scope
  • Review and approve CRA travel expenses and time sheets

KNOWLEDGE, SKILLS & ABILITIES:

  • Prior experience as a Lead Clinical Research Associate or Regional Clinical Study Manager.
  • Strong communication skills (verbal and written) to express complex ideas. Fluency in spoken and written English.
  • Excellent organizational and interpersonal skills.
  • Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
  • Ability to manage multiple priorities within various clinical trials.
  • Willingness and ability to travel domestically and internationally, as required.

This role is home based, permanent and full time.

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: R1092506