Job Description

Senior Clinical Data Manager – FSP / oncology experience

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 be responsible for the full cycle of Clinical Data Management queries, from being in full leadership of your own studies and being the main point of contact with the client, to the most hands-on tasks such as creating eCRFs, cleaning data and performing independently set-up to close-outs duties. You will cooperate in a highly collaborative environment with other Clinical Data Managers, Data Coordinators, Statistical Programmers and others.

What you can expect from us

• Office based or home based anywhere in the listed countries
• Exposure to high profile global studies with
• 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

What you will do

• Provides CDM leadership for one or more assigned projects or indications dependent on size and scale of the project.
• 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.
• 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)
• 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
• Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.

Your profile

• University/college degree (life science, pharmacy or related subject preferred)

• 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.
• Extensive experience in clinical data management and experience leading studies in a CRO/Pharma setting.
• 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, and systems applications to support operations.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.

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