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Clinical Data Manager

Systex, Inc. Rockville, MD, USA

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

Why Work Here?

“Great Benefits, wonderful team, and intriguing work”

Systex, Inc. is a growing Federal Government contractor providing Information Technology (IT) services for the National Institutes of Health for over 40 years. We are currently seeking qualified candidates to join our Clinical Data Management leadership team to help provide expertise and oversight of Clinical Data Management projects. The position will work solely on-site in Rockville, Maryland (currently working remotely due to COVID-19).

Duties include, but are not limited to:

  • Provide leadership support to our Data Management team.
  • Demonstrated subject matter expertise in all aspects of the Data Management (DM) discipline.
  • Responsible for the oversight of clinical data management study deliverables
  • Evaluates and mitigates data management-related risks across functional areas.
  • Provide technical oversight of core data management functions including CRF/edit check development, user acceptance testing, biostatistics, data cleaning, listings review, and database lock procedures.
  • Represent Data Management on clinical project teams.
  • Work with project teams (i.e., Customer, Project Management, Clinical, Data Management Operations, Biostatistics and Medical Writing as needed) in defining DM timelines/deliverables for projects.
  • Manage the production, review, and authorization of the database/system.
  • Code, test, and document databases as per programming standards and clinical validation policies.
  • Review Data Validation Plans and Case Report Forms as per area of expertise.
  • Oversee Validation Programming according to standards agreed to for each specific project.
  • Define processes for data integration across various platforms, and all external data sources such as ECG and lab within clinical database.
  • Responsible for documentation that complies with database design and validation.
  • Assist with development and implementation of new technology and initiatives.
  • Support development, revision and maintenance of core operating procedures and working instructions.
  • Interface with project team to organize responsibilities and deliverables.
  • Support data migration activities including data cleaning and adjudication processes.
  • Implement data standards within a function, or therapeutic area in accordance with industry standards.
  • Responsible for programming and QC across a trial/asset, including submission activities, adhering to relevant SOPs/policies.
  • Contribute subject matter expertise to support process improvement initiatives.
  • Understanding of US regulations and guidelines applicable to clinical trials, inspection readiness and system validation.
  • Domestic and international travel (no more than 25%) to resource-limited countries.

The right candidate will have the following qualifications:

  • Bachelor’s degree in statistics, mathematics, computer science, pharmacy, nursing, biology or related scientific field.
  • Minimum of eight (8) years Clinical Data Management experience within the clinical research industry.
  • Successfully lead and completed several DM operations projects.
  • Knowledge of ICH-GCP with a strong interest in clinical research as well as Clinical trials systems knowledge (e.g., REDCap, DFdiscover, OpenClinica, etc) required.
  • Knowledge of non-SAS programming packages/languages (e.g., Tableau, Spotfire, S-Plus, R) a plus.
  • Working knowledge of CDISC data standards, primarily the creation and use of CDASH, SDTM and ADaM datasets preferred.
  • Excellent analytical, organizational and time management skills required.
  • Strong verbal and written communication skills.

Company address: Fishers Lane, Rockville, Maryland

Posted date: 20 days ago

View all Jobs at Systex, Inc.