Associate Clinical Data Manager – FSP
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Job Description
Associate Clinical Data Manager supporting sponsor-dedicated clinical trials at Fortrea. Managing clinical data queries, study timelines, validation processes, and data management standards.
Responsibilities:
- Responsible for the full cycle of Clinical Data Management queries
- Cooperate with Clinical Data Managers, Data Coordinators, Statistical Programmers and others
- Assist and lead operations 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 follow study timelines for on-time deliverables
- Assist or lead internal and external DM meetings
- Manage proactively risks and resolve or escalate issues connected to Clinical Data Management improvement or technology
- Develop understanding of CDASH and SDTM or other recognized industry standards and their impact on programming teams
- Specialize in TA-specific data capture and standards, conduct lessons learned and disseminate them across the organization
- May act as a team leader or mentor Clinical Data Management colleagues and stakeholders on operational processes
- Lead project-level activities consistent with current or previous experience in support of study delivery
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:
- Various local benefits such as pension contributions
- Complimentary health insurance plans
- Remote working allowances
- Genuine work life balance
- Flexibility in working hours
- Thorough onboarding with support from a personal mentor
- Permanent employment contract with Fortrea Drug Development
- Rewarding career progression
- Mentoring, training and personalized development planning
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