Principal Clinical Data Manager

1 semana atrás

Lisboa, Lisboa, Portugal Fortrea Tempo inteiro
Principal Clinical Data Manager - Late Phase (EMEA - home or office based)


As an experienced Principal Clinical Data Manager in our Late Phase (IIb-III-IV) multi-sponsor business unit, you are central to the successful delivery of complex clinical trials for renowned, innovative and global top pharmaceutical and biotech companies.

you will work alongside the leadership team to provide guidance, mentoring and training to the DM team.

You will lead multiple studies and take responsibility for the development of project documentation, system set up, data entry & validation.


This is a great opportunity for someone who wants to advance their Data Management exposure, working alongside the leadership team in a technical and non-managerial DM role.

What you can expect from us

  • Office based or home based in Portugal.
  • 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 Fortrea

Your responsibilities:

  • Lead a variety of complexed studies, including healthy volunteer and patient populations, multisite, involving complex protocol design.
  • Be accountable for all DM deliverables, as assigned per timeline, providing instruction to their DM study team and reviewing completed work.
  • Ensure all projects are completed according to relevant protocols, SOPs and GCP standards.
  • Work with Project Managers to build timelines to meet contracted milestones via communication with other Data Managers and during study initiation meetings.
  • DM project leadership and accountability, lead DM internal meetings, meet frequently with study leads of EDC Design, SAS Programming, Stats & PK to ensure all deliverables are planned and coordinated.
  • Identify risks/mitigations, effectively communicates to ensure database lock dates are achieved.
  • Develop and maintain client relationships, drive process improvements and team training.
  • Support Managers with regards to performance evaluation of other team members, aid their career development.
  • Support budget development process for DM opportunities.

Profile:

  • Demonstrated history of working in lead clinical data management within clinical research
  • Must be fluent in English language (both verbal and written)
  • Extensive work experience in data management, including direct sponsor management and technical mentoring experience.
  • Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives to encourage team members to seek solutions.
  • Demonstrated skill for technical management of staff.
  • Experience representing DM in bid defense meetings, providing innovative solutions.
  • 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 and to encourage team members to seek solutions.
  • Demonstrated managerial and interpersonal skills.
Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply.

For more information about how we collect and store your personal data, please see our

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