Kelly Services Job - 31530919 | CareerArc
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Company: Kelly Services
Location: Cambridge, MA
Career Level: Entry Level
Industries: Recruitment Agency, Staffing, Job Board

Description

Seeking a Clinical Data Management Technology Contractor V for a 12 month assignment in Cambridge, MA.

• CRO oversight experience & either oncology or neuroscience – need one or the other, both is a plus.

Position Title: Senior Manager-Clinical Data Solutions


OBJECTIVES:

  • Responsible for timely and high quality data management deliverables supporting the portfolio.
  • Establish asset and study level strategies and services, including excellence in the application of standards.
  • Conduct oversight using, predictive data monitoring practices from database activation through database release and submission.
  • Contributes to the management of vendor partnerships to maximize effectiveness and maintain budgets.
  • Provides and enables solutions for complex problem solving that align with the Takeda values.
  • Serves as a clinical data management expert and provides guidance on CDISC standards.


ACCOUNTABILITIES:

• Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and copmany for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Contributes influential leadership in collaboration with other Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
• Provides input to functional governance with strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
• Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
• Oversees the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
• Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of the company.
• Participates and represents function in formal inspections and audits as requested.
• Other duties as assigned

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• BS/BA required preferably in a health-related, life science area and with a minimum of 10 years data management and/or drug development experience.
• Proven track record of strong project management skills and experience managing data management activities for large drug development programs
• Experience with all phases of development and at least 2 therapeutic areas.
• Ability to handle multiple development programs simultaneously.
• NDA/CTD Experience.
• Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
• Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.
• Good understanding of CDISC standards, and experience implementing standards.
• Strong knowledge of clinical study reporting requirements including SAS programming.
• Advanced knowledge of office software (Microsoft Office).
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles.
• Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools.
• Good working knowledge of general statistical programming processes and practices.
Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.

TRAVEL REQUIREMENTS:
• Access to transportation to attend various meetings held in proximity to the offices.
• Able to fly to various meetings at investigator, vendor or regulatory agency sites.
• Some international travel may be required.

APPLY NOW!

For immediate consideration, please send your resume to gaut985@kellyservices.com



Why Kelly®

With Kelly, you'll have access to some of the world's highest regarded scientific organizations—providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

]] About Kelly Services

Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.

Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.

Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.


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