Sr. Clinical Database Programmer
Company: Cognitive Research Corporation
Location: Saint Petersburg
Posted on: January 12, 2022
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
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
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
- 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
- Monitors applications proactively for workflow alerts, system
errors, performance issues and troubleshoot programming deliverable
- 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
- 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
- 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
- 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
- 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
- Working with SAS outputs is preferred but not required.
- Able to communicate effectively through both written and verbal
- 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 team.by Jobble
Keywords: Cognitive Research Corporation, St. Petersburg , Sr. Clinical Database Programmer, IT / Software / Systems , Saint Petersburg, Florida
Didn't find what you're looking for? Search again!