Job Information
WCG Clinical Clinical Systems Associate Data Manager (Remote) in Indianapolis, Indiana
Clinical Systems Associate Data Manager (Remote)
General Information
Location: Indianapolis, IN, Remote
Organization: Trifecta Clinical
Job Type: Full Time - Regular
Description and Requirements
ABOUT WCG: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.
WHY WE LOVE WCG: At WCG, our employees are our most valuable asset and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health and to help them make the most of their future.
Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
Employee Assistance Programs and additional work/life resources
Referral Bonuses and Tuition Reimbursement
Paid time off including holidays, vacation, and sick time
Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement
Expected hourly range: $18.65 to $26.92 (range is expected, specific compensation offered may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience)
GPS Level: B3
JOB SUMMARY: The Clinical Systems Associate Data Manager ensures the timely upload of adverse events and performs user management requests in the company’s InvestigatorSpace (IS) system as well as ensuring our clients are always in a state of inspection readiness. Conducts thorough QC checks of all adverse event uploads and is responsible for navigating the IS.
ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The accountabilities listed below are representative of the knowledge, skills, and/or ability required.
Provides rapid data entry support for global user access to the IS product as needed
Enters and uploads for distribution customer and account data from source documents within a timely manner
Ensures global users are uploaded efficiently, to the correct studies and sites as well as ensures events are distributed to sites via the company’s IS product
Reviews data for deficiencies or errors and provides feedback to co-workers as part of the QC process for adverse event uploads. Follows-up and updates customer status and information
Provides comprehensive support to teams and sites in relation to global user’s access.
Processes global user’s system access to the clinical safety notification distribution portal
Ensures the company continuously meets the required safety reporting requirement timelines set forth by the FDA for INDs
Works within deadlines, ensuring timely, cost-effective delivery and client satisfaction
Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
EDUCATION REQUIREMENTS:
- Bachelor’s degree in related field and/or equivalent experience to perform the job
QUALIFICATIONS/EXPERIENCE:
Minimum of 1-2 years data entry experience
Minimum of 1-2 years customer service experience
Excellent professional communication (written and oral), interpersonal, and organizational skills
Effective problem-solving skills
Customer-oriented and patient with ability to deal with difficult customers.
Ability to view problems holistically and communicate solutions to management
Experience with excel and manipulation of spreadsheets preferred
Strong analytical abilities
Self-starter who works as well independently as they do as part of a team
Experience with a Pharmacovigilance system such as Aris or Argus is a plus
Serve as first escalation point for business administration questions and QA if required
SUPERVISORY RESPONSIBILITIES: None
TRAVEL REQUIREMENTS: 0% - 5%
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WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender identity, age, marital status, disability, genetic information, citizenship, veteran status, reprisal or any other legally recognized basis or status protected by federal, state or local law.