Janesville, WI - Mercyhealth Hospital and Trauma Center - Ortho/Neuro Unit Days (6:30A-7P)

Generis Tek Inc.

🇺🇸 United States
On-site
Manager or above
14 hours ago

Regulatory Compliance
Oracle
GCP

14 hours ago

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Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition SpecialistPriyanka Mahantat email address Priyanka.mahant@generistek.com can be reached on #(630) 576-1940.

We haveContractrole Clinical Data Manager for client atMaple Grove, MN.Please let me know if you or any of your friends would be interested in this position.

Position Details:
Clinical Data Manager- Maple Grove, MN
Location                       : 6820 Wedgewood Road N., Maple Grove, MN – 55311 (100% Onsite)
Project Duration      : 6 Months of contract (Potential to Extend)
Shift Timing              : 8:00 AM to 4:00 PM (Mon to Fri)

Job Description:
Our location in Maple Grove, MN currently has an on-site opportunity for a Study Database Manager –Data Management professional. The Study Database Manager is responsible for clinical database development and maintenance; validation of deliverables; adherence to processes, systems, standards, and best practices with attention to quality and regulatory compliance. Through cross-functional collaboration, the Study Database Manager will review Case Report Form (CRF) design, study protocol review and provide input. They will review database specification functional requirements and Edit Check specifications and provide feedback. They will lead and/or participate in set-up of clinical study databases in a clinical data management system including programming of edit checks. Ensure that standards and conventions are followed and data structure is fit for purpose for downstream reporting.

What You’ll Work On:

Follow company software development lifecycle to design, code, configure, test, debug, and document clinical study databases using a clinical data management system.
Collaborate with other development staff to achieve quality and consistency.
Problem solver and decision maker with the ability to handle multiple tasks simultaneously.
Actively participates in the escalation of live errors and service problems to limit downtime and resolve problems.
Team player that develops high level design for solutions.
Debugs, troubleshoots, and isolates clinical data management systems as well as offers strategic solutions, analysis, and advice regarding identified issues for future development.
Ability to work creatively and productively with minimal supervision.
Participate in the review of clinical research protocols, reports, and statistical analysis plans.

Required Qualifications:

Minimum 5 years’ experience working for a Medical Device, Pharmaceutical or Biopharmaceutical Company.
Minimum 2 years’ experience using a clinical data management system performing clinical study database setup including edit check programming.

Preferred Qualifications:

Prior experience in study specific database configuration utilizing Oracle Clinical, Oracle Clinical Inform, or Oracle Life Sciences Cloud or other data management systems.
Experience in adherence to FDA 21 CFR Part 11 and Guidance for Good Clinical Practices (GCP) data-handling procedures and guidelines.

Top Skills Needed:

Analytical and critical thinking skills along with related prior data management experience.
Great communication skills with a focus on collaboration.
Confident in leading discussions and managing complex regulated studies.
Experience in effectively influencing a team decision to the desired outcome.

To discuss this amazing opportunity, reach out to our Talent Acquisition SpecialistPriyanka Mahantat email address Priyanka.mahant@generistek.com can be reached on #(630) 576-1940.

About generis Tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.

Janesville, WI - Mercyhealth Hospital and Trauma Center - Ortho/Neuro Unit Days (6:30A-7P) · Generis Tek Inc.

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