Product Owner, Services Application SCRI
IT SCRI - Nashville, TN

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GENERAL SUMMARY OF DUTIES

– Supervises the development, implementation, and management of solutions for pharmaceutical sponsors to streamline clinical research. The Product Owner of SCRI Services Applications will serve as the primary lead for clinical research solutions including the Siebel CTMS ultimately accountable for the business planning, implementation, integration with SCRI clinical and administrative systems, and vendor management of the solutions.

REPORTS TO:
Director, Application Services

SUPERVISES:
Business Analysts

DUTIES INCLUDE BUT ARE NOT LIMITED TO:
  • Collaborates with Services Leadership to determine which technology addresses their needs and translates those needs into system requirements and design specifications.
  • Develop and implement data integration strategy between selected SCRI’s clinical systems (e.g. Siebel Clinical, Argus, Omnicomm Systems)
  • Manages the use rollout of clinical trial portal solutions and clinical trial management solutions for SCRI’s Pharmaceutical Partners
  • Manage the design and implementation of SCRI Services’ reporting strategy within a portal environment
  • Serve as an expert in Business Process Management (BPM) in the IT area and support or lead product development efforts by providing resource and schedule estimations, and status update on product builds
  • Analyze current state clinical, administrative, and financial processes and recommend automated, streamlined business process solutions related to SCRI Services Division
  • Lead the preparation of system development artifacts such as requirements, analysis, design and test documentation and system documentation including user guides and system administration procedures for portal and workflow applications
  • Assist CIO in the development of IT&S strategies using strategic planning concepts.
  • Improve productivity and efficiency; promote continuous improvement
  • Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”
  • Performs other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES

  • Knowledge of architecting, deploying, and maintaining a Siebel Clinical infrastructure preferred
  • Knowledge of Electronic Data Capture systems (EDC) such as Medidata, Phase Forward, or Omnicomm preferred
  • Knowledge of pharmacovigilance systems such as Argus preferred
  • Knowledge of business process improvement, workflows, evaluation of processes, business process modeling and data modeling preferred
  • Knowledge of BPM tools (preferably Metastorm Business Process Management Suite software) used to model, build, test and implement BPM solutions preferred
  • Ability to accomplish IT project assignments, analyzing a number of alternative approaches in the process of advising management on aspects of IT system development, operations and solutions.
  • Proven ability to multi-task in fast paced environment is essential.
  • Strong interpersonal, communication, and organizational skills.
  • Ability to communicate policies to users and tasks to direct reports.
  • Ability to manage, organize, and make decisions.
  • Ability to manage, organize, and make decisions.
Qualifications

EDUCATION

  • A degree in computer science, mathematics or a related field / M.S. degree is preferred.
EXPERIENCE

  • 3-5 years of Clinical Product Management industry experience in clinical research
  • Experience in the pharmaceutical industry handling Electronic Data Capturing (EDC), Clinical Data Management (CDMS), Clinical Trial Management (CTMS) and Clinical Programming Management (CPM) for at least 2 years with an overall experience in IT for 4 - 8 years.
  • Experience with Contract Research Organizations (CROs) preferred
  • 3+ years supervisory experience preferred
  • Knowledge of regulatory guidelines (i.e. HIPAA, 21 CRF Part 11, GCP)
CERTIFICATE/LICENSE

  • None
PHYSICAL DEMANDS/WORKING CONDITIONS

– The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requires prolonged sitting and some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare, and communicate appropriate reports. Requires lifting papers or boxes up to 50 pounds occasionally. Requires dexterity to type 60 wpm. Work is performed in an office environment and involves frequent contact with staff and the public.

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