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Clinical Data Manager - Early Phase

Role overview

Qualifications

  • University/college degree (life science, pharmacy or related subject) or certification in a related allied health profession
  • 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, data management, biometrics, quality management, and systems applications to support operations

Responsibilities

  • Lead early-phase DM studies (healthy volunteers and patients) across multiple sites with client management while prioritizing workload and timelines
  • Ensure all DM deliverables meet established timelines; supervise DM study teams and review outputs to ensure high quality while adjusting resources as needed
  • Track scope changes, secure Sponsor approval, and coordinate with the Project Manager to process the scope change
  • Provide leadership, mentorship, and coaching in DM processes; stay current with new DM technologies and process improvements

About the company

Fortrea logo

Fortrea

Contract Research Organizations (CRO)

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.

Company details

Company typeXLarge
IndustryContract Research Organizations (CRO)
Company size10001

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Job description

Clinical Data Manager - Early Phase – full remote or hybrid

Do you have experience leading data management activities across early phase studies? Are you looking for a new challenge in an environment where youwill be closely supported by your Manager, peers and Senior Leaders in your team? Perhaps you are seeking to gain further experience in new therapeutic areas.

Join our growing team and discover your extraordinary potential by working as a Clinical Data Manager within our Early Phase team. 

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

  • Lead studies including (but not limited to) a combination of healthy volunteer and patient
  • populations, multi-site, client management required or reduced timelines. Ability to
  • organize and effectively prioritize workload and deliverables.
  • Be accountable for all DM deliverables as assigned per the established timeline; providing
  • instruction to their DM study team(s) and review of their study team’s output to ensure the
  • highest quality, while adjusting resource allocations accordingly.
  • Develop and maintain client relationships and review client satisfaction surveys.
  • Track scope changes and work with the Project Manager to ensure that Sponsor approval is
  • received, and the scope change processed.
  • Provides leadership, mentorship, and coaching in DM related clinical trial processes to the
  • internal study team.
  • Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Fortrea.

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.

#LI-MA1 #LI-Remote #LI-Hybrid

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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