Senior Clinical Data Manager

4 weeks ago

Maidenhead Berkshire, United Kingdom Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. Senior Clinical Data Manager (oncology trials) - FSP - fully home-based anywhere in EMEA
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.
Our unique opportunity will allow you to bring your specialized discipline to a core team outsourced to a world class leading global healthcare company. Dedicated to our Client 100% of the time, you will play a key role in the drug development cycle and see a product through to launch with the support of both a dedicated Fortrea line manager and our client project teams.
The Senior 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 also be able to manage the oversight of activities in data management on large scale projects.
Office based or home based anywhere in Europe
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
A permanent employment contract with Fortrea Drug Development and a rewarding career progression

Provides CDM leadership for one or more assigned projects or indications dependent on size and scale of the project. Takes global accountability and serves as the second line of contact at the project level
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
Primary point of contact for Clinical Data Management (CDM)
Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned programs, (i.e. ensuring consistency across data quality plans.)
Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology
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

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 actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does 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. For more information about how we collect and store your personal data, please see our Privacy Statement . #

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