Lead Clinical Data Management Specialist

7 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 extensive clinical development expertise, 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 domains. With a workforce exceeding 19,000 professionals operating in more than 90 countries, we are reshaping the landscape of drug and device development for our partners and patients worldwide.

Position Overview: Senior Clinical Data Manager – FSP – Fully Remote within EMEA

The role of Senior Clinical Data Manager within our Functional Service Provider (FSPx) division presents an exciting opportunity to engage in a dynamic and collaborative work environment, while being part of a globally recognized team. You will have the autonomy to navigate your career path with support from exceptional colleagues and a wide range of professional development opportunities.

In this position, you will take charge of the complete cycle of Clinical Data Management activities, serving as the primary liaison with clients and overseeing your own studies. Your responsibilities will encompass both strategic leadership and hands-on tasks, including the creation of electronic Case Report Forms (eCRFs), data cleansing, and managing all phases from study initiation to closure. Collaboration with fellow Clinical Data Managers, Data Coordinators, Statistical Programmers, and other stakeholders will be essential.

What We Offer

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

Key Responsibilities

  • Provide leadership in Clinical Data Management for assigned projects, ensuring global accountability and serving as a 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 contract 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 consistent application of CDM processes and documentation across assigned programs
  • Oversee external service providers or in-house teams to ensure compliance with study procedures and standards, providing guidance on company expectations
  • Manage risks proactively and resolve issues related to Clinical Data Management enhancements or technology
  • Develop familiarity with CDASH and SDTM standards to ensure consistency in programming
  • Specialize in therapeutic area-specific data capture and disseminate lessons learned across the organization
  • Mentor Clinical Data Management colleagues and stakeholders in operational processes
  • Demonstrate a willingness to lead project-level activities in support of study delivery

Candidate Profile

  • University degree in life sciences, pharmacy, or a related field, or certification in an allied health profession from an accredited institution
  • Proven experience in leading complex oncology clinical trials
  • Extensive background in clinical data management within a CRO or pharmaceutical environment
  • Strong oral and written communication and presentation skills
  • In-depth knowledge of clinical trial processes, data management, clinical operations, and quality management systems
  • Understanding of the regulatory obligations of the CRO industry in relation to pharmaceutical and biotechnological companies
  • Ability to lead teams effectively and encourage problem-solving among team members
  • Demonstrated managerial and interpersonal skills

MAI Fortrea Development Limited is actively seeking innovative thinkers and motivated problem-solvers who share our commitment to advancing clinical trials. Our mission is to transform the development process, ensuring the rapid delivery of life-changing therapies to patients in need. Join us in a collaborative environment that fosters personal growth and enables you to make a significant global impact.

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