Posted 3 days ago
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Description
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 to help 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
- Flexible PTO
- Volunteer Time Off to benefit the community
- Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement
Expected annual base salary range: $18.65 to $26.92
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
TRAVEL REQUIREMENTS:
? 0% - 5%
? 5% - 10%
? 10% - 20%
? 20% - 50%
? >50%
Physical and Sensory Requirements: The physical and sensory requirements 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 offered to individuals with disabilities to assist in performing the essential functions of the position. Work activities involve light to moderate physical effort (for example, sitting in one place for extended periods of time, standing, walking, bending, lifting lightweight objects, intermittent to sustained periods of keyboarding). Majority of time is spent in a seated position with frequent opportunity to move about at will. Activities require a variety of easy muscle movements. Work activities involve a frequent need to concentrate on a variety of sensory inputs for moderate to lengthy durations at a time requiring diligence and attention to interpret effectively. There will be a need to attend to single or simultaneous tasks where accuracy of details is important. The need for detailed and precise work is high.
