Senior Clinical Data Manager

3 giorni fa


Milano, Lombardia, Italia MAI Fortrea Development Limited A tempo pieno

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, MAI Fortrea Development Limited provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, we are transforming drug and device development for partners and patients across the globe.

 

Senior Clinical Data Manager – FSP – fully home-based anywhere in EMEA

We are seeking a skilled and experienced Senior Clinical Data Manager to join our Functional Service Provider (FSPx) team. As a key member of our team, you will be responsible for the full cycle of Clinical Data Management queries, from being in full leadership of your own studies and being the main point of contact with the client, to the most hands-on tasks such as creating eCRFs, cleaning data, and performing independently set-up to close-outs duties.

You will cooperate in a highly collaborative environment with other Clinical Data Managers, Data Coordinators, Statistical Programmers, and others. Our team is dedicated to delivering high-quality solutions that meet the needs of our clients, and we are looking for someone who shares our commitment to excellence.

Key Responsibilities:

  • Provides CDM leadership for one or more assigned projects or indications dependent on size and scale of the project.
  • Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level.
  • Communicates and negotiates effectively with all other Program level team members.
  • Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.
  • May act as a team leader or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.

Requirements:

  • University/college degree (life science, pharmacy, or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution.
  • Experience in leading complex oncology clinical trials.
  • Extensive experience in clinical data management and experience leading studies in a CRO/Pharma setting.
  • Excellent oral and written communication and presentation skills.
  • In-depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.

We are an equal opportunities employer and welcome applications from all qualified candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

What we offer:

  • Office based or home based anywhere in Europe.
  • Rewarding and meaningful work in an established, diverse, highly profitable, and respected global company.
  • Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances, etc.
  • A genuine work-life balance.
  • Flexibility in working hours.
  • A thorough onboarding with support from your personal mentor.
  • A permanent employment contract with MAI Fortrea Development Limited and a rewarding career progression.


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