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Clinical Data Manager, Medical Affairs

BioMarin Pharmaceutical Inc.

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Location: San Rafael, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: 13-0009 Required Education: High school or equivalent

Description

BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 13-0009  

RESPONSIBILITIES:
• Define and direct the data management workflow for assigned projects in collaboration with statistician ensuring all necessary data quality control and integrity measures are in place
• Work with statistician on the prioritization of projects and establish plans for meeting timelines agreed with study management teams
• Serve as the data management subject matter expert on multidisciplinary project teams providing specific expertise on timeline development, identification of data management deliverables and resource requirements
• Participate in the creation, review, and maintenance of project timelines and monitor progress of data management activities
• Assist in the preparation and review of specifications for designing, monitoring and transferring of electronic databases
• Assist in the development and implementation of the design and programming of clinical databases
• Perform user acceptance testing on database applications and data transfers
• Create, review, approve and maintain edit specification, CRF design, CRF Completion Guidelines, data cleaning procedures and other data management supportive tools with study team members according to protocol specific requirements and available guidance documents
• Review, analyze, and validate clinical trial data throughout the study lifecycle to ensure data consistency,completeness, integrity and accuracy based on project specific guidelines
• Query data inconsistencies and revise CRFs when necessary to comply with company and/or regulatory guidance and standard operating procedures.
• Generate and review reports and listings as required to maintain data integrity and reporting
• Communicate study status, timeline updates, scope changes with internal study team members and departmental leadership
• Lead the data cleaning process, track and resolve queries for the study lifecycle, close out and database lock procedures in collaboration with the study team leads
• Manage and/or liaise with 3rd party vendors specifically related to data collection, analysis and project timelines
• Develop strong working relationships and maintain effective communication with MAF SM study team member including lead team member, statistician, statistical programmer and other cross functional contributors
• Assist in developing data management process and procedure improvements, and standard operating procedures
• Generate data retrievals and summaries.

To apply: Visit www.BMRN.com Job Code 13-0009

Requirements

EDUCATION:
• Bachelor’s Degree and/or equivalent experience in Life Science, Nursing, Computer Science or related disciplines or equivalent combination experience and education
• Expertise in EDC and Medidata Rave, preferred, database development
• Extensive clinical data management experience in Pharmaceutical and/or CRO setting

EXPERIENCE:
• 4+ years of experience in data management, of which 2+ years in a leadership role as a Team Leader for a significant clinical program, Proficiency in Microsoft Office tools
• Comprehension of medical terminology
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
• Proficient experience using commercial clinical data management systems and/or EDC products (e.g. RAVE, Inform, Oracle Clinical/RDC, etc.)
• Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle)


To apply: Visit www.BMRN.com Job Code 13-0009
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