Associate Clinical Data Manager - FSP

• 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.

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