Biostatistics Team Associate 2 - office based Reading
Closing Date: 19 Feb 17
Type: Full Time
Salary (£): Negotiable
PURPOSEProvide project related assistance for assigned project(s) and project teams with guidance. Will ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.RESPONSIBILITIES
Assist in the administrative maintenance and tracking of project documentation including all files, records and reports according to the scope of work and SOPs (e.g. ...
Provide project related assistance for assigned project(s) and project teams with guidance. Will ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Assist in the administrative maintenance and tracking of project documentation including all files, records and reports according to the scope of work and SOPs (e.g. set up and collect signatures for tracking docs, RFFs, CAFs, uploading materials to eTMF).
- Set up meetings and record meeting minutes, notes and actions at assigned meetings and distribute accordingly (including key customer meetings and Lessons Learned meetings and setting up LL spreadsheet).
- Support the Biostatistics Team Leads (BTLs) with updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information (including internal metrics reports).
- Assist the BTL(s) with setting up project plan (translate budget to FTEs and provide top level timeline plan), allocation of team members to tasks (tracking document).
- Perform monthly finance activities, where appropriate (e.g. Timesheet verification, provision of revenue and backlog information to PLs/PMAs, and support BTL(s) performing PM role with invoicing activities).
- Support the preparation of presentation materials for meetings (internal/external) and project summary data.
- Support the coordination of project team and/or customer meetings including logistics and materials required.
- Create project areas
- Use DPI Tool and Delegation Management Tool to support management of Project Creation, Access Granting and Email Groups management, when applicable.
- Maintain the list of project unblinded personnel.
- Create delivery archive folder and include all relevant materials (SAS main and QC programs, all log/lst files, all raw/SDTM/ADaM datasets used for the delivery and the outputs delivered to the customer).
- Set up transfer method between Q and customer (e.g. sFTP).
- Coordinate the transfer of Biostats materials for archiving.
- At the appropriate timepoint, provide information required to issue Biostatistics customer survey.
- Submit project related expense reports for project team members.
- Perform any other tasks, as requested by Biostatistics JENA Owner or Line Manager.
MINIMUM REQUIRED EDUCATION AND EXPERIENCEHigh school Diploma with at least 2 years of related experience in a clinical research environment and a high ability to reason and to apply numerical concepts; or equivalent combination of education, training and experience.
- Strong planning, team work and organizational skills
- Very good communication and interpersonal skills
- Strong software and computer skills, including MS Office applications
- Extensive knowledge of MS Excel
- Good knowledge of Financial Systems used at Quintiles
- Ability to handle conflicting priorities and effectively manage multiple tasks and projects
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Results and detail-oriented approach to work delivery and output
- Excellent customer service skills