Lead Clinical Data Management Specialist

6 giorni fa

Roma, Lazio, Italia MAI Fortrea Development Limited A tempo pieno

About MAI Fortrea Development Limited

As a prominent global contract research organization (CRO) dedicated to scientific excellence and with extensive experience in clinical development, MAI Fortrea Development Limited offers pharmaceutical, biotechnology, and medical device clients a comprehensive suite of clinical development, patient access, and technological solutions across over 20 therapeutic areas. With a workforce exceeding 19,000 professionals operating in more than 90 countries, we are at the forefront of transforming drug and device development for our partners and patients worldwide.

Position: Senior Clinical Data Manager – FSP – Fully Remote in EMEA

The Senior Clinical Data Manager position within our Functional Service Provider (FSPx) division presents an exciting opportunity to work in a dynamic and collaborative environment. You will be part of a world-class team, supported by exceptional colleagues globally, and will have access to a multitude of career development options, including mentoring, training, and personalized growth planning.

In this role, you will oversee the complete cycle of Clinical Data Management activities, taking full leadership of your assigned studies while serving as the primary contact for clients. Your responsibilities will encompass both strategic oversight and hands-on tasks, including the creation of electronic Case Report Forms (eCRFs), data cleaning, and managing all phases from study initiation to closure. You will collaborate closely with other Clinical Data Managers, Data Coordinators, Statistical Programmers, and various stakeholders.

What We Offer

  • Flexible work arrangements, either office-based or remote across Europe
  • Meaningful and impactful work within a well-established, diverse, and respected global organization
  • Competitive compensation packages, including local benefits such as pension contributions, health insurance, and remote work allowances
  • A commitment to work-life balance
  • Flexible working hours
  • Comprehensive onboarding process with dedicated mentorship
  • Permanent employment contract with opportunities for career advancement

Your Responsibilities

  • Provide leadership in Clinical Data Management for one or more assigned projects, ensuring global accountability and serving as the secondary contact at the project level
  • Exhibit operational expertise in the strategic planning and execution of CDM deliverables at both program and project levels, including vendor management and budget oversight
  • Effectively communicate and negotiate with all program-level team members, acting as the primary contact for Clinical Data Management
  • Understand the compound profile to ensure the application of consistent CDM processes and documentation across assigned programs
  • Oversee external service providers or in-house teams to ensure quality data delivery in compliance with study procedures and standards
  • Proactively manage risks and resolve issues related to Clinical Data Management improvements or technology
  • Develop familiarity with CDASH and SDTM standards to ensure consistency in program-level standards
  • Specialize in therapeutic area-specific data capture and standards, sharing insights across the organization as appropriate
  • Mentor Clinical Data Management colleagues and stakeholders on operational processes used in studies and projects
  • Demonstrate a willingness to lead project-level activities in support of study delivery

Your Profile

  • A university degree in life sciences, pharmacy, or a related field, or certification in a relevant allied health profession
  • Proven experience in leading complex oncology clinical trials
  • Extensive background in clinical data management, particularly in a CRO or pharmaceutical environment
  • Strong oral and written communication and presentation skills
  • In-depth knowledge of the clinical trial process, data management, clinical operations, biometrics, and quality management
  • Understanding of the regulatory obligations of the CRO industry in relation to pharmaceutical and biotechnological companies
  • Ability to lead teams effectively, fostering a collaborative environment focused on achieving departmental goals
  • Demonstrated managerial and interpersonal skills

MAI Fortrea Development Limited is actively seeking motivated and innovative individuals who are passionate about overcoming challenges in clinical trials. Our unwavering commitment is to enhance the development process, ensuring the timely delivery of transformative ideas and therapies to patients in need.

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