Senior Clinical Data Manager
6 days ago
Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
About the Role
- As a Senior Clinical Data Manager, you will be responsible for the full cycle of Clinical Data Management queries, from leadership of your own studies to hands-on tasks such as creating eCRFs, cleaning data, and performing set-up to close-out duties.
- You will cooperate in a highly collaborative environment with other Clinical Data Managers, Data Coordinators, Statistical Programmers, and others.
What You'll Get
- Office based or home based anywhere in Europe
- 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
- Provides CDM leadership for one or more assigned projects or indications dependent on size and scale of the project.
- Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level.
- Management and oversight of vendor contracts, resourcing, and budget management and oversight of vendor performance for assigned programs and projects.
- 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 leader 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).
- Experience in leading complex oncology clinical trials.
- Extensive experience in clinical data management and experience leading studies in a CRO/Pharma setting.
- 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.
- Ability to lead teams by example on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
Fortrea is an Equal Opportunity Employer
We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
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