Data Manager

Description

KEY SKILLS & BEHAVIORS

Exemplify, deliver and expect professionalism using strong interpersonal and organizational skills

Facilitates high quality work ensuring appropriate use of SOPs, guidelines and technical standards. Has high degree of accuracy and attention to detail

Anticipates changing priorities and demands and addresses them proactively

Keeps an internal and external client informed of project and/or technical issues by pro-actively communicating across teams/functions Communicates effectively through both written and verbal methods

TRAINING AND EXPERIENCE

1. Medical/Nursing, Life Science/Mathematical Degree or relevant experience
2. 7+ yrs. experience as Data Manager (or proven managerial experience).
3. Some Travel


LOCATION

Remote from anywhere in the US or Canada

JOB SUMMARY

Supervise all project data processing tasks. Work to departmental SOPs, guidelines and global standards to ensure data integrity.

JOB RESPONSIBILITIES

Thorough understanding of Clinical Data Management tasks and assigned protocol(s) with ability to critically evaluate the information in relation to other key project documents and processes.

Monitor tasks vs. contractual obligations for CDM and report any out of scope items to the Project Data Manager. Provide oversight to external suppliers such as EDC vendors.

Coordinate, create and maintain the Data Management Plan, eCRF Completion Guidelines and training materials. Work with KickStart and Sponsor on start-up activities. Sign off on documentation as required by SOPs and WPGs. Attend & present CDM materials at Investigator & CRA meetings.

Attend internal and external project meetings providing input from a CDM perspective. Ensure assigned actions are completed within the required timeframe.

Assist with tracking of project status, task completion, and staff productivity. Determine status of incoming data, site responsiveness, need for escalation for backlog to various functions within Theorem or sponsor. Report and discuss findings with Project Data Manager

Review and approve post production change control study documentation.

Ensure filing of study specific documentation as required by SOPs and WPGs and study needs. Maintain all data management study documents in the designated TrialShare area and PMF as required.

Provide reports to Sponsor and internal team as dictated by project need.

Be a resource to CDM team for questions and guidance as related to clinical data.

Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.

Gather and consolidate feedback, metrics and status reports from CDM Team Leads to assess CDA performance and quality of deliverables. Escalate any performance and quality issues to PDM.

Ensure company and departmental SOPs and standards are adhered to.

Provide feedback for performance evaluation and competency of Data Managers and assist with skill/career development for direct reports.

Be responsible for effective management of projects/sponsor groups, and assigned Data Managers (max. 4).

Present CDM function at conferences and external non-study meetings.