Hi,
Please review the following requirement and let me know if you have any consultants.
THE CONSULTANT MUST BE GC OR CITIZEN LOCAL TO CT.
Location: Groton,CT
Duration: 6+ months
Description:
Business analyst working with clinical, Safety and BT to ensure appropriate documentation of business (functional and non functional) requirements
Document , track activities relative to the integration solution
Author and manage SDLC documentation
Communicate issues, risks, decisions and status of BA activities and deliverables.
Facilitate workshops, requirements gathering and review sessions. Some workshops will be in conjunction with the interface Vendor.
POSITION RESPONSIBILITIES
In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.
Business analyst working with clinical, Safety and BT to ensure appropriate documentation of business (functional and non functional) requirements
Document , track activities relative to the integration solution
Author and manage SDLC documentation
Communicate issues, risks, decisions and status of BA activities and deliverables.
Facilitate workshops, requirements gathering and review sessions. Some workshops will be in conjunction with the interface Vendor.
ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
Clinical Business
Clinical BT
Safety Business
Safety BT
Information management
Oracle
TECHNICAL SKILLS REQUIREMENTS
Indicate the technical skills required and/or preferred, as applicable.
• Outstanding verbal and written communication skills; strong listening skills with the ability to proactively define and manage required communication channels internal and external to the organization.
• Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally.
• Demonstrated knowledge of clinical development and the pharmacovigilance Serious Adverse Event processes and requirements.
• Knowledge of clinical development and pharmacovigilance process including in-depth knowledge of the principles of GCP, the Serious Adverse Event process, understanding of the concepts of Phase I-IV and principles of study design.
EDUCATION AND EXPERIENCE
• Pharmacovigilance, Serious Adverse Event (SAE) processes or Clinical Trial/Study Operations Experience
• Knowledge of INFORM/ARGUS
• Familiarity with EDC or Pharmacovigilance systems a plus
• 4 year degree with at least 5 years working experience as a BA
Thanks & Regards
Madhukar Reddy
Resource Manager
Benali Business Solutions
7111 Harwin Dr #272, Houston, TX 77036
email: sreddy@benn-ali.com
Phone: 470-298-7333
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