Records Management Assistant

Job Purpose:

A Records Management Associate (RMA) has basic knowledge about Parexel’s specific paper and electronic Trial Master File (TMF) processes and procedures. The Records Management Associate contributes to the assigned tasks within the project from a basic to an intermediate level. Develops the knowledge on how Parexel delivers to our client’s TMF needs and achieves department’s overall business objectives. Works closely with other levels within Records Management and under Line Manager (LM) supervision to meet project requirements. Depending on the location and assignments, the role of an RMA may include tracking, scanning, filing, entry and return of electronic Case Report Forms to clients for assigned projects; checking and processing documents to the electronic document management system; activities associated with Impact Harmony, as appropriate. The RMA may be delegated other TMF related tasks under LM supervision.  These tasks may include a mixture of billable and non-billable work to support eTMF Controller service ticket closures.  Those assigned to support the eTMF Controller functional role must be proficient with our eTMF system/ processes, problem solving, taking initiative, and working independently. 

A Sr. Records Management Associate assumes the ability to meet the requirements of a RMA with a high degree of proficiency and consistent quality of work.  Offers leadership support and constructive feedback to project team members. Exhibits a sense of urgency about solving problems and completing assigned work.

Key Accountabilities:

Accountability

Supporting Activities

TMF Maintenance

- Maintain electronic and paper TMF for ongoing studies according to Parexel SOP’s or contractual obligation to sponsor.

- Upload, process, apply naming / metadata convention and file or process TMF documents in electronic document management system as required for project team members.

- Manage document reconciliation between systems, where a manual process is required

- Follow quality control procedures to ensure accurate maintenance of files.

TMF support

- Manage other TMF delegated tasks as assigned by LM

- Based on skill and experience, may support with system related tasks

Skills:

• Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management  Systems, eTMF systems 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

Knowledge and Experience:

• Experience in office management in an international environment would be advisable

Education:

• Relevant qualification or equivalent experience required

• Bachelor’s degree preferred (or relevant clinical or business equivalent)