Associate Clinical Data Manager - FSP

Fortrea Development India Private Limited; United States; Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

Pension contributions

Health insurance plans

Remote working allowances

Permanent contract

Work-life balance

Job summary

Fortrea Drug Development seeks an Associate Clinical Data Manager to lead data management activities on sponsor-dedicated projects, with remote or office-based work options. You will collaborate with Senior CDM, Data Coordinators, and statisticians to manage data capture, validation and study timelines, ensuring on-time deliverables.

The role requires a life sciences background with experience in early-phase trials, strong written and verbal communication, and a solid grasp of CDASH/SDTM

Qualifications

• Lead DM or Senior CDA experience in early phase trials at CRO/pharma.
• Excellent oral and written communication and presentation skills.
• Knowledge of clinical trial process, data management, biometrics and quality management.

Responsibilities

• Assist and lead operations alongside Senior CDM and junior staff.
• Develop study documentation, system setups and data validation processes.
• Lead internal and external Data Management meetings.
• Proactively manage risks and resolve issues related to CDM improvements or technology.
• Ensure CDASH/SDTM standards alignment and program-level consistency.

Skills

Lead DM experience

Excellent communication

Regulatory knowledge

Education

Life science degree or related field

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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