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Sr. Clinical Database Programmer

Company: Cognitive Research Corporation
Location: Saint Petersburg
Posted on: January 12, 2022

Job Description:

About Us:
Cognitive Research Corporation (CRC) is a privately held clinical research organization specializing in CNS research. CRC was incorporated in 2006 and has grown to a team of 100. We are a full-service CRO providing comprehensive clinical operations, data management and statistical analysis services. CRC brings to our clients, industry recognized expertise in cognitive assessment, driving assessment, evaluation of movement disorders, and application of neurological and psychiatric rating scales. We have a truly exceptional Biostatistics team and a robust network of Clinical Investigators who support Phase 1 through Phase 4 clinical trials.CRC has contributed to the program design, drug development and registration of numerous FDA and globally approved medicines.
We are committed to our employees and proactively support the professional growth of individuals. We are a diverse group of professionals that proactively foster a positive workplace culture to work, learn and contribute to bringing medicines to patients.
Position Summary:The Sr. Clinical Database Programmer manages and supports all functional tasks and project deliverables from single study assignments to large portfolio of studies. Manages multiple project timelines and deliverable whilst leading and mentoring less experienced programmers. Designs, writes, validates, and maintains databases to meet industry and CRC standard specifications. Serves as the senior technical subject matter expert by supporting staff in Electronic Data Capture (EDC), reporting, and processing tools. May work with IT to monitor internal and external hosted applications for performance and/or system errors. May have supervisory responsibility and/or oversight for a team of lead clinical programmers within a program.Key Responsibilities:

  • Provides application administration and technical support as the subject matter expert on all core Electronic Data Capture systems, including but not limited to: Medrio, Medidata, rED Cap, ClinPlus, Oracle OC/RDC, SAS, and supplemental packages such as migration mentoring/review, reporting tools, custom functions, etc. Utilizes primary development tools and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
  • Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRF)s, database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.
  • Monitors applications proactively for workflow alerts, system errors, performance issues and troubleshoot programming deliverable defects.
  • Performs system integrations activities, application updates, and user acceptance testing.
  • Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
  • Participates in and provides input at project review and departmental review meetings. Participates in bid defenses, as appropriate.
  • Ensures high quality deliverables by providing senior review of program level/multi-study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits.
  • Reviews and provides input on study budgets, manages project level metrics, progress, and status, for large programs of studies from key sponsors. Monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Assists with the creation of change orders.
  • Provides leadership, mentorship, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications and uses expanded technical skills to meet evolving project needs.
  • Provides leadership/oversight of concurrent studies depending upon scope, similarity, program, and resourcing requirements. This may include the oversight of other lead programmers and their associated studies.
  • Manages project resources, proactively alerting management of delivery and resourcing needs.
  • Assists with management of application vendors and serves as an initial escalation contact. Monitors vendor service level agreements (SLAs) and reports metrics to upper management.
  • Assists with the implementations of upgrades and new modules of remotely hosted vendors, acquiring all documentation and storing in the relevant areas.
  • Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.
  • Contributes towards the update of standard operating procedures and work instructions in line with department and company process and policy.
  • As required, oversees program level clinical programming operations by providing supervision for a team of clinical programmers. Responsibilities may include professional development performance appraisals, and employee advising for junior staff. Assigns project work and reviews workload for all direct reports. Manages staff development by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level. Resolves conflicts/priorities at the program level prior to making any recommendations to management. Advises on administrative policies and procedures, technical problems, priorities, and methods.Minimum Qualifications:
    • Bachelors degree in scientific, biological, statistical, computer science related field; Associate Degree with previous proven experience is acceptable.
    • Minimum of 5 years hands on experience in the clinical research industry serving in a Clinical Database Programmer capacity. Preference will be given to previous CRO/Pharma experience and direct experience programming in Medrio, Redcap, CLinPlus and substantial familiarity with RAVE
    • SAS programming capability highly preferred
    • Knowledge of CDASH standards is highly desired.
    • Proficient in understanding GCP, ICH and FDA guidelines
    • Proficient working knowledge of clinical database build, maintenance and close-out processes from study start up through database lock.
    • Working with SAS outputs is preferred but not required.
    • Able to communicate effectively through both written and verbal methods.
    • Must be able to work independently following a brief period of specific technical training and onboarding.
    • Understands how to prioritize deliverables and proactively address any challenges with meeting the deadline of said deliverables to the project Jobble

Keywords: Cognitive Research Corporation, St. Petersburg , Sr. Clinical Database Programmer, IT / Software / Systems , Saint Petersburg, Florida

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