Director, Medical Information Technology

Opportunities like this definitely do not come along everyday, so don't miss out on this rare opportunity!

We currently have an incredible opportunity at Parexel for a Director, Medical Information Technology! This innovative leader will propel our technology to the next level and truly make their mark on our Business!

A Director, Medical Information Technology will:

Provide management, general oversight and direction for global Medical Information Technology Specialist.

Guide the performance of the Medical Information Technology Specialist team in ongoing projects in terms of quality and compliance.

Provide technology support and guidance for Safety Operations - assist in the set up and maintenance of the all safety databases.

Develop, validate, install, implement, and train on all technical aspects within Safety Operations.

Serve in a Leadership role for the in-house Safety Operations, safety database (currently Argus Safety), extending to installation, implementation, training, maintenance, ongoing support, further development and replacement with future technologies.

Provide technical support and training for the safety database used by Safety Operations.

Ensure system performance and reliability of the safety database to meet the needs of Safety Operations.

Assist with the identification and co-ordination of standardized applications and methodologies relating to the safety database.

Monitor, understand and implement the changing regulatory requirements.

Act as a point of contact both internally and with external clients to develop programs and processes to meet requirements of both contracts and regulatory agencies.

Work with Data Management Group to improve procedures for database reconciliation between safety and clinical databases.

Manage the handover of the safety database from Client to Parexel where contracted to take over the pharmacovigilance tasks for client projects.

Ensure safety database setup and administration, application and users support, training, documentation, validation and user acceptance per individual client project.

Serve as the central contact and escalation point to troubleshoot, track and monitor safety database performance and reported issues. Work closely with Safety Operations staff or vendor support to ensure proper analysis, resolution and closure of issues.

Coordinate software updates change requests and application support for the safety database.

Employ continuous improvement methodologies to ensure best service to the business, minimize waste and optimize the safety database support process.

Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, Information Systems Procedures and Quality standards (such as SDLC and dual environment).

Interface with other Information Technology groups (such as TQM,GTS) to ensure that database, hardware, network, security, quality, integration, support and project services associated with maintained systems are adequate and sufficiently managed.QualificationsSkills:

· Excellent interpersonal, verbal and written communication skills

· Client focused approach to work

· A flexible attitude with respect to work assignments and new learning

· Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

· Willingness to work in a matrix environment and to value the importance of teamwork.

· Excellent problem-solving skills.

· Strong understanding of E2B and Regulatory processes

Knowledge and Experience:

· Experience in the maintenance and support of databases that support a worldwide-distributed user base within a regulated industry environment

· Specific experience in Argus Safety and ORACLE is required while experience in one or more of the following areas: SAS, SQL, Arisg, PL/SQL, VB and any other I.T. discipline that would be of value for safety databases will also be helpful

· Understanding of the Clinical Research and development process including Post-market, in particular with respect to patient safety and regulatory reporting requirements

· Previous experience managing a global team is strongly preferred

· Previous CRO experience is strongly preferred

Education:

· University/College degree in Life Science with strong technology background.EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.