Senior Clinical Data Manager

Senior Clinical Data Manager (Contractor)

 

ABOUT THE POSITION:

The Senior Clinical Data Manager is responsible for Clinical Data Management (CDM) support for clinical studies following Standard Operating Procedures (SOP) and Guidelines. The person in this position should work as the lead clinical data manager for clinical trials and works closely with the lead clinician and biostatistician to develop the data management plan and electronic Case Report Forms (eCRF), build the Electronic Data Caption (EDC) system, author and program the Edit Check specifications, lead and guide the UAT of the EDC system, cooperate with lead EDC validation personal, lead data review, generate and solve data queries, create operational data sets, reconcile external data sets and safety data sets, perform database lock activities.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

  • Participate in planning and support of clinical studies.
  • Implement CDISC/CDASH standards in CDM.
  • Prepare eCRFs and lead the team review of the forms ensuring compliance with company standards
  • Build or participate in the EDC building.
  • Develops programs and manages the edit check specifications and its implementation.
  • Program EDC custom functions in SAS.
  • Perform, oversee, and document EDC user acceptance testing.
  • Perform and document EDC validation using GAMP5.
  • Facilitate and document review of clinical data by other functional groups.
  • Reconcile external data sets and safety database with clinical database using SAS
  • Raise manual queries that result for data review and reconciliation activities.
  • Resolve system and manual queries and perform database lock.
  • Oversee CRO data managers and their data management activities for outsourced studies.
  • Perform other duties as necessary as assigned by management.

QUALIFICATIONS:

Core competencies, education, and experience.

  • A minimum of 5+ in a pharmaceutical and/or a biotech company as a clinical data manager..
  • BS Degree or above
  • Expertise in building electronic data capture systems such as Medidata RAVE, and in programming system edit checks.
  • Expertise in electronic case report forms,, and data management plan development.
  • Understanding of the MedDRA and WHODRUG coding processes.
  • Strong project management, and written and verbal communication skills.
  • Ability to mentor junior clinical data managers..
  • SAS Certification preferred.
  • FDA/EMA inspection experience preferred

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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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