Senior Clinical Data Manager
4 weeks ago
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. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
About the RoleWe are seeking a highly skilled and experienced Senior Clinical Data Manager to join our team. As a key member of our Clinical Data Management department, you will be responsible for leading complex oncology clinical trials and ensuring the delivery of high-quality data to our clients.
Key Responsibilities- Provide CDM leadership for one or more assigned projects or indications, taking global accountability and serving as the second line of contact at the project level.
- Demonstrate leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level, including management and oversight of vendor contracts, resourcing and budget management, and oversight of vendor performance.
- Communicate and negotiate effectively with all other Program level team members, serving as the primary point of contact for Clinical Data Management (CDM).
- Demonstrate a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned programs.
- Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards, giving guidance on company standards, processes, systems, and expectations to external partners, internal partners, and third-party vendors.
- Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology.
- Develop 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.
- Demonstrate 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.
- 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.
- 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.
- Demonstrated managerial and interpersonal skills.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.
Please use the below Lifelancer link for job application and quicker response.
https://lifelancer.com/jobs/view/ded216cb82bbacd014463be6cff17a03
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