Senior Clinical Data Manager – Oncology

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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. • Lead studies including healthy volunteer and patient populations • Demonstrates leadership and operational expertise in planning and delivery of CDM deliverables • Management and oversight of vendor contracts, resourcing and budget management • Communicates and negotiates effectively with Program level team members. • Primary point of contact for Clinical Data Management (CDM) • Provides oversight and expertise of external service providers or in-house teams • Responsible for proactive risk management and issue resolution/escalation • Develops an understanding of CDASH and SDTM or other recognized industry standards

🎯 Requirements

• University/college degree (life science, pharmacy or related subject preferred) • 8 years of combined early or late-stage DM experience • Minimum 2 years of direct sponsor management • At least 2 years technical mentoring experience • Extensive experience in clinical data management • Understanding of RECIST criteria • Excellent oral and written communication and presentation skills • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, systems applications to support operations. • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies

🏖️ Benefits

• Highly competitive compensation packages • Various local benefits such as pension contributions • Complimentary health insurance plans • Remote working allowances • Genuine work life balance • Flexibility in working hours • Thorough onboarding with support from personal mentor