Clinical Data Manager Leader for Oncology Trials

Há 2 dias


Lisboa, Lisboa, Portugal MAI Fortrea Development Limited Tempo inteiro

MAI Fortrea Development Limited is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience.

Salary

We offer a highly competitive compensation package, including a salary range of $80,000 - $120,000 per year, depending on experience, as well as various local benefits such as pension contributions, complimentary health insurance plans, and remote working allowances.

Job Description

The Senior Clinical Data Manager role is a key position within our sponsor dedicated department. You will be responsible for providing leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level. This includes managing and overseeing vendor contracts, resourcing and budget management, and vendor performance for assigned programs and projects.

You will serve as the second line of contact at the project level and demonstrate leadership and operational expertise in the strategic planning and delivery of CDM deliverables. You will communicate and negotiate effectively with all other Program level team members and be the primary point of contact for Clinical Data Management (CDM).

You will also be responsible for developing an understanding of CDASH and SDTM or other recognized industry standards and their impact to programming teams to ensure consistency of program level standards. Additionally, you will specialize in TA specific data capture and standards, conduct lessons learned, and disseminate across the organization as appropriate.

This is a great opportunity to work within our sponsor dedicated department and have a unique relationship with a sponsor. You will also be able to manage the oversight of activities in data management on large scale projects.

Required Skills and Qualifications
  • University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
  • 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
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies
  • Ability to lead teams by example on project strategies and achievement of department goals, objectives, and initiatives
  • Demonstrated managerial and interpersonal skills
Benefits

We offer a genuine work-life balance, flexibility in working hours, and a thorough onboarding with support from your personal mentor. You will also have the opportunity to develop a rewarding career progression and enjoy a permanent employment contract with MAI Fortrea Development Limited.

Others

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.


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