Associate Clinical Data Manager - FSP

Fortrea; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Fortrea is seeking an Associate Clinical Data Manager for sponsor-dedicated work, offering remote options. You will manage full cycle of CDM queries and collaborate with a global team of CDMs, data coordinators, and statisticians to ensure study delivery.

The role emphasizes mentorship, onboarding, and a permanent contract with Fortrea Drug Development, with opportunities for career progression and a flexible work schedule.

Qualifications

• University/college degree in life science, pharmacy or related subject preferred, or certification in allied health profession.
• 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.

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

Skills

Communication

Clinical data management

Team collaboration

Education

Bachelor's degree in life science / related field

Certification in allied health profession

Job description

Associate Clinical Data Manager – sponsor-dedicated - remote

Joining Fortrea’s Clinical Data Management sponsor dedicated team will offer a rewarding career, a chance to work in an energetic & team-oriented workplace and exposure within a world-leading team. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

The Associate Clinical Data Manager role is a great opportunity to work within our sponsor dedicated department and have this unique relationship with a sponsor. You will be responsible for the full cycle of Clinical Data Management queries. You will cooperate in a highly collaborative environment with other Clinical Data Managers, Data Coordinators, Statistical Programmers and others.

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

• 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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