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À propos de ce poste Associate Clinical Data Manager - FSP chez Fortrea

Fortrea · Sur site · Bucharest

Associate Clinical Data Manager – sponsor-dedicated - remote

 

Joining Fortrea’s Clinical Data Management sponsor dedicated team will offer a rewarding career, a chance to work in an energetic & team-oriented workplace and exposure within a world-leading team. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

 

The Associate Clinical Data Manager role is a great opportunity to work within our sponsor dedicated department and have this unique relationship with a sponsor. You will be responsible for the full cycle of Clinical Data Management queries. You will cooperate in a highly collaborative environment with other Clinical Data Managers, Data Coordinators, Statistical Programmers and others.

 

 

What you can expect from us

  • Office based or home based anywhere in the listed countries

·       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 Drug Development and a rewarding career progression

 

 

Your responsibilities

·       Assist and lead operations team alongside Senior CDM, develop project documentation, system setup, data validation processes and procedures assigned to junior staff. 

·       Work with Senior CDM to build study milestone timelines and be able to read and follow study timelines for on-time deliverables.

·       Assist or lead internal and external DM meetings.

·       Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology

·       Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.

·       Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate

·       May act as a team leaders or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.

·       Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery

 

Your profile

  • 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).
  • Additional relevant work experience will be considered in lieu of formal qualifications.
  • Experience in clinical data management as a Lead DM or Senior CDA or similar within early phase trials at CRO/pharma level.
  • 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.

Learn more about our EEO & Accommodations request here.

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À propos de Fortrea

At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

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