Senior Clinical Data Manager – Sponsor Dedicated

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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