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Senior Clinical Programmer Analyst

Cambridge, MA

Posted: 04/10/2019 Employment Type: Direct Hire Job Category: Clinical: Data Management Job Number: 2273

Our client is looking for a Senior Clinical Programmer Analyst to join its team on a permanent basis. The person in this role is responsible for leading multiple large and complex Clinical Programming projects in support of Electronic Data Capture (EDC), external data handling, and data visualization.  Performs and delegates tasks according to the standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. Effectively manages vendors.  Mentors junior personnel.  Develops SOPs and application-specific procedures.

Job Responsibilities:
  • Successfully solves unique and complex problems that have a critical impact on the business and driving solutions based on best practices
  • Provide technical and business expertise in support of data deliverables
  • Ensure compliance with SOPs and Work Instructions
  • Ensure timeliness and quality of data report deliverables in collaboration with CDM team members and cross-functional colleagues
  • Enable use of consistent programming approaches across Therapeutic Areas through adoption of standards and best practices
  • Participate in initiatives around process development, standardization, and technology
  • Anticipate opportunities and problems, and offer solutions and best practices around database design, data standards, and programming methodology
  • Contributes to the development of the functional strategy, such as EDC system selection and implementation or enhancement of clinical data accessibility as a subject matter expert
  • Leads cross-functional technology initiatives and oversees external vendors, as appropriate

Requirements / Qualifications:
  • Bachelor’ s degree, preferably in health science or related field
  • In-depth and breadth of clinical expertise in database design, data standards, and data output programming using multiple technology solutions
  • Broad knowledge of Clinical Data Management and other Clinical Development functions
  • Demonstrates ability to anticipate internal business challenges and successfully drives towards the best solution for the organization
  • Recognized as an EDC, external data handling, and data visualization expert, and is an escalation pathway throughout Clinical Development organization
  • Must be able to work in a highly matrixed fast-paced environment with changing priorities and deadlines
  • Proven track record of designing, leading and executing initiatives such as EDC global library design or standard data visualization implementation, that have meaningful impact on critical goals
  • Highly organized and detail oriented
  • Able to manage time effectively and prioritize
  • GCP and Therapeutic Area knowledge
  • Demonstrated experience in writing professional correspondence and clinical study documentation
  • Strong EDC skills in various EDC systems, e.g., Medidata Rave and IBM Health
  • Experience with clinical trial data technologies a must, including: programming in SQL, utilizing data repositories (elluminate® experience preferred), and developing reports / visualizations using BI tools (Qlik a plus)
  • Strong understanding of clinical trial data
  • Strong communication skills

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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