Associate Clinical Data Manager – FSP

This is a fully remote position, open to applicants in Romania, +5 more countries.

📋 Description

• Accountable for the complete cycle of Clinical Data Management inquiries.

• Collaborate with Clinical Data Managers, Data Coordinators, Statistical Programmers, and others.

• Support and lead operations in conjunction with the Senior CDM.

• Create project documentation, system setup, and data validation processes, while guiding junior staff.

• Partner with the Senior CDM to establish study milestone timelines and ensure timely delivery of study objectives.

• Facilitate or lead both internal and external DM meetings.

• Proactively manage risks and address or escalate issues related to enhancements in Clinical Data Management or technology.

• Cultivate an understanding of CDASH and SDTM or other acknowledged industry standards and their influence on programming teams.

• Focus on TA-specific data capture and standards, conduct lessons learned, and share insights across the organization.

• May serve as a team leader or mentor for Clinical Data Management colleagues and stakeholders regarding operational processes.

• Direct project-level activities in alignment with current or prior experience to support study delivery.

⛳️ Requirements

• University or college degree (preferably in life sciences, pharmacy, or a related field), or certification in a relevant allied health profession from a recognized institution (e.g., nursing certification, medical or laboratory technology).

• Additional pertinent work experience may be considered as a substitute for formal qualifications.

• Proven experience in clinical data management as a Lead DM, Senior CDA, or similar roles within early phase trials at CRO or pharmaceutical levels.

• Exceptional oral and written communication and presentation abilities.

• Comprehensive knowledge of the clinical trial process, data management, clinical operations, biometrics, quality management, and systems applications that support operations.

• Familiarity with the relationship and regulatory obligations of the CRO industry in relation to pharmaceutical and biotechnological companies.

🏝️ Benefits

• A variety of local benefits, including pension contributions.

• Complimentary health insurance plans.

• Remote working allowances.

• A genuine work-life balance.

• Flexible working hours.

• Comprehensive onboarding with support from a personal mentor.

• Permanent employment contract with Fortrea Drug Development.

• Opportunities for rewarding career progression.

• Mentoring, training, and tailored development planning.