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.
Requirements
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.
Benefits
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