Records Management Assistant....PAREXEL....h4

http://jobs.parexel.com/in/hyderabad/data-management/jobid5624437-records-management-assistant


Job Description : Essential Function
The role of the Records Management Assistant (RMA) is to maintain the paper and electronic Central
Files for Global Research Operations, ensuring efficiency, accuracy and quality.
Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case
Report Forms to clients for assigned projects, upload and naming of documents to the electronic
document management system, EDC User Management activities and activities associated with Impact
Harmony, as appropriate.
Key Accountabilities
• Create Central Files for new studies and maintain Central Files for ongoing studies according to
PAREXEL SOP’s or contractual obligation to sponsor
• Track and scan paper Case Report Forms, as required
• Upload, apply naming convention and file Central Files documents in electronic document
management system as required for project team members
• Support retrieval of documents
• Enter clinical trials data into the appropriate database, if required
• Photocopy, print and distribute documents, as needed
• Ensure up to date study documents in tracking systems / document repositories
• Maintain quality control procedures to ensure accurate maintenance of files
• Perform archive procedures upon study termination: prepare copies of Central Files as required by
Sponsor and PAREXEL Internal Records
• Support EDC User Management activities, as required
• Support Impact Harmony activities, as required
• Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local
regulatory requirements and PAREXEL SOPs and WSOPs and study specific procedure
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense
claims
Skills
• Good computer skills including but not limited to the knowledge of Clinical Trial/Data
Management Systems, PMED and MS-Office products such as Excel, Word
• Good oral and written communication skills
• Ability to successfully work in a (“virtual”) team environment
• Ability to prioritize multiple tasks and achieve project timeline
• Effective time management in order to meet daily metrics or team objectives
• Shows commitment to and performs consistently high quality work
• Able to work independently but seek guidance when necessary, escalating issues as required
• Commitment to consistent high quality work
• Sense of urgency in completing assigned tasks
Education
• Relevant qualification or equivalent experience required
• High school diploma – ideally degree in life science or other related background - preferred

Qualifications : 
Minimum Work Experience
• Experience in handling clinical documents (Trail Master File) in an international environment would be advisable.