Job Description

Senior Clinical Data Manager – Medical Device

The Senior Clinical Data Manager role is a great opportunity to work within our Medical Device Team 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)

• Multiyear experience of 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/Medical Device 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.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.

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