Assisting in maintaining the corporate Electronic Document Management System (\"EDMS\") by:
* Creating, deleting and updating user accounts to reflect personnel changes including role assignments.
* Assisting global end-user support both remotely and in-person for basic EDMS trouble-shooting such as lockouts and user credential verifications.
* Providing basic EDMS training and guidance to staff regarding the use of the system.
* Assisting in EDMS integration activity by revising documentation, courses, users, roles, grandfathering and basic EDMS activity as necessary.
* Updating and maintaining document tracking such as Table of Contents and SharePoint sites based on relevant documentation.
* Revising and creating controlled documentation and placing into appropriate templates according to the SOP on Controlled documents.
* Collaborating with authors on documents, attachments, forms and templates that are out-of-compliance or in need of revision.
* Identifying opportunities for document Retirement, preparing the Document Retirement Form and obtain signatures. Archiving document in the EDMS and other tracking mechanisms.
* Preparing and assisting in audits by providing requested information, producing and interpreting reports as required, and providing administrative support.
* Identifying opportunities to improve the end-user experience for EDMS and Document Management procedures.
Maintains Quality Service and Departmental Standards by:
* Reading, understanding and adhering to organizational Standard Operating Procedures (\"SOP\").
* Assisting in establishing and enforcing departmental standards.
Contributes to team effort by:
* Working with internal staff to resolve issues.
* Exploring new opportunities to add value to organization and departmental processes.
* Helping others to achieve results.
* Performing other duties as assigned.
Maintains Technical and Industry Knowledge by:
* Attending and participating in applicable company-sponsored training.
Bachelor's Degree Preferred
1+ years of relevant experience in a Pharmaceutical or CRO environment preferred.
Working knowledge of GCP, ICH guidelines and FDA regulations.
Intermediate to advanced knowledge of Microsoft Office and SharePoint preferred.
Ability to prioritize requirements and delegate tasks to meet goals.
Excellent organization and time management skills are required to manage multiple projects simultaneously.
Able to work independently and provide support to others.
Self-motivated, flexible and adaptable to business needs.
Additional skill set:
Advance Word skills.
Ability to work in group setting and independently; ability to adjust to changing priorities.
Excellent attention to detail and orientation toward meticulous work.
Strong interpersonal and communication skills, both verbal and written.
Strong documentation and organizational skills.
Other: Computer work for long periods of time
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.