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București, România
Remote only
Senior Clinical Data Manager – fully home-based
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.
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
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
Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables
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
Communicates and negotiates effectively with all other Program level team members. 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; give 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
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).
8 years of combined early or late-stage DM experience with minimum 2 years of direct sponsor management and at least 2 years technical mentoring experience. Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets.
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.
#LI-MA1 #LI-Remote #LI-Hybrid
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