Records Management Specialist

Cencora • Boston, MA

22h • Hybrid

About The Position

This is a hybrid role with on-site working required up to 3 days per week at the customer office. The purpose of the role is to support the administration of Clinical Records Management, ensuring compliance with all appropriate Records Management policies and procedures as well as the Records Retention schedule. The role is intended to maintain the operations of the physical records room(s) regarding archiving, indexing, and retrieval of critical and non-critical physical records, requiring on-site work at the client site. This also includes the management of off-site records storage activities. The position supports the administration of Clinical Records Management Programs, ensuring records are managed and maintained according to company policies and procedures, departmental policies/procedures, and in accordance with defined retention times and legal holds. It provides guidance to maintain the integrity of the archived records, including working with staff to determine the best options for their needs, developing and maintaining tracking sheets that fit each document collection, and determining the most appropriate location for the physical records (on-site or off-site) and the appropriate system for the archiving of scanned/electronic imported records.

Requirements

• 2+ years of Trial Master File (TMF Management) experience is required
• High level of understanding of the use of Microsoft Excel and other Office products
• Demonstrated ability to work with reasonable independence, take initiative, complete tasks to deadlines
• Strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines
• Good communication skills and customer focus
• Good organizational, interpersonal and problem solving skills
• Proven ability to communicate effectively and responding to inquiries and concerns
• Demonstrated ability to be flexible and to adapt quickly to change
• Good teamwork, organizational, interpersonal, and problem solving skills
• Fluent business English (oral and written)
• Able to lift and move boxes of documents

Nice To Haves

• 4+ years' experience in pharmaceutical industry, clinical research organization, or records management related role preferred.
• Awareness of regulatory requirements for clinical trials (ICH/GCP) pertaining to records management preferred
• Experience with use of electronic Records Management Systems preferred

Responsibilities

• Supports the administration of the Clinical Records Management Programs ensuring records are managed and maintained according to company policies and procedures, departmental policies/procedures and in accordance with defined retention times and legal holds.
• Provides guidance to maintain the integrity of the archived records. This includes working with staff to determine the best options for their needs—including but not limited to developing and maintaining tracking sheets that fit each document collection and determining the most appropriate location for the physical records (on site or offsite) and the appropriate system for the archiving of scanned/electronic imported records.
• Archival and indexing of critical and non-critical physical records including processing, maintaining, and tracking document collections.
• Provides guidance on assisting staff with record searches and retrieval requests.
• Archives the Clinical Research physical records stored at external vendors and is the primary contact for offsite storage and retrieval of records.
• Oversees management of the on-site clinical records room and is the primary contact for on-site and timely access of records.
• May support and facilitate records access requirements during regulatory inspection in collaboration with Clinical Document Management and Trial Support and applicable functions.
• Actively manages and maintains the electronic archive database including working with vendor on implementing or updating system.
• Execution of inventories of physical records according to requirements outlined in Clinical Records procedures.
• Satisfactorily completes all required training in conformance with departmental requirements.
• Performs other duties as assigned associated with records management initiatives.

Benefits

• Compensation
• Benefits
• Resources that enable a highly inclusive culture
• Support for team members’ ability to live with purpose every day
• Medical care
• Dental care
• Vision care
• Comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
• Support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave
• Variety of training programs
• Professional development resources
• Opportunities to participate in mentorship programs
• Employee resource groups
• Volunteer activities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed