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Job Title: SENIOR PROJECT DATA MANAGER
Job Location: NJ: Nutley
Pay Rate: Open
Job Length: full time
Start Date: 2008-09-19

Company Name: Roche
Contact: Recruiter
Phone: email only please
Fax: email only please

Description: Job ID: 00012062 SENIOR PROJECT DATA MANAGER Job facts: Job function Development Location United States - New Jersey Nutley Company/ Division Pharmaceuticals Schedule Full-time Job type StandardJump to contact information Who we are: At Roche, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves. The Position: As a core member of the Clinical Team, the Project Data Manager is accountable for the leadership, planning and delivery of all Data Management activities within a project(s) to ensure the effective and efficient delivery of standardised quality data for clinical evaluation and statistical analysis.

Principle Accountabilities and Responsibilities:

Provides global leadership to one of more Project Data Management teams

Builds effective, high performing Data Management teams through influence, integration, motivation and optimizing team performance. Embeds the Roche values into the team culture and promotes team spirit.

Develops and maintains effective working relationships with, and is the primary data management contact at the Project Level for Clinical Team members, key stakeholders, co-development partners and CROs.

Maintains awareness of internal and external clinical Data Management practices.

Ensures the Project Data Management teams are aware of the risks, priorities, value and impact of their work and contributions.

Provides support for each Study Data Manager on the project and ensures they are aware of and perform their area of responsibility, contribution and participation in their SMTs and to their Study Data Management teams(s).

Provides training to Project Data Management Team, on project specific standards and procedures and the therapeutic area.

In collaboration with Line Management, coaches and supports Project Data Management team members to ensure performance is optimized on the project.

Communicates regularly on project status and escalates unresolved issues appropriately to Operations Project Leader and Line Manager.

Provide support and maintains awareness of Data Management processes to the Clinical Team as appropriate.

* Establishes Data Management resource, timelines, risk management and quality plans in line with overall project plan

Contributes to the Clinical Development Plan strategy and Clinical Team goals.

In accordance with the overall project plan, plans, prioritizes and organizes the Data Management Plan in collaboration with the Operations Project Leader (OPM for pharmacology studies).

Plans, prioritizes and organizes Data Management needs to deliver the studies on time, with the most efficient use of budget and resource.

Supports the Study Data Managers in review of Data Management timelines and resources in the study plans and monitors the Study Data Managers' input to the plans over the course of the studies.

Calculates and defines project resource estimates for the OPL for entry into the project plan.

Works with PDOC Resource Planners to agree a Resourcing Strategy across studies, then, with Line Managers ensures that the project is adequately and optimally resourced. Follows up pro-actively when issues occur and elevates to the relevant Line Manager.

Develops and implements standard project data quality, risk management, audit (if appropriate), and contingency plans for the Data Management deliverables and ensures use of standard project dataflow reports and tracking of planned versus actual of the Data Management activity reports.

Assesses impact of outsourcing, EDC and initiatives on the Data Management process, data quality, Data Management resources and timelines and amends the plans accordingly.

Manages the delivery of Data Management activities in order to meet project plan(s)

Monitors Data Management metrics, data quality and dataflow against SMT goals, project Data Quality Plans and Clinical Development Plan.

Reviews and becomes familiar with the protocol synopsis, protocol and protocol amendments to ensure compliance with project standards.

Reviews CRF and appropriate study related documentation to ensure compliance with global and project standards

Evaluates Data Management progress with each Study Data Management team, identifies issues and decides on corrective actions.

Ensures the delivery of any Data Management corrective action plan.

Chairs Project Data Management team meetings, ensuring their preparation, conduct, documentation and follow-up on action points.

Oversees the delivery of data to Statistics for analyses.

Point of contact for Study Data Management of relevant strategic partners to ensure Data Management practices are consistent and the delivery of data is in line with agreed standards.

· Representation of Project Data Management team at the Clinical Team

Develops the Data Management strategy for the project ensuring coordination and delivery across all Project Data Management team.

Ensures needs and contributions of the Project Data Management team are incorporated into the project timelines and resources.

Ensures updates/issues from these functions are properly addressed and communicated within the Clinical Team.

Communicates relevant decisions made at the Clinical Team back to the Project Data Management team.

* Defines scope of work, provides direction and oversight of outsourced Data Management activities to ensure CRO and vendor delivery against contract

Primary Data Management point of contact with Business Manager (PDOR).

Participates in CRO and vendor selection, evaluation and management and involves relevant Project Data Management team expert as appropriate.

Ensures project standards are provided to the CRO Data Management to ensure consistency across the project. Understands, coordinates and provides oversight to the process with vendors.

Leads the development, review and finalization of the Data Management scope of work providing main assumptions and information on key drivers.

Maintains oversight of Data Management performance and deliverables to ensure delivery is in line with scope of work.

Addresses issues identified relating to Data Management performance to CRO counterpart and escalates in line with Outsourcing Issue Escalation Process.

Ensures safe data exchange systems are set up with external business partner to facilitate access to each others systems.

* Identifies areas of best practice and process improvements, drives implementation and evaluation of standards across one or more Project Data Management teams.

Proactively incorporates Data Management learnings and recommendations from study debriefs into best practices.

Contributes to activities to improve and maintain the quality and effectiveness of Data Management processes within the function.

Promotes Data Management best practice across SMTs (internal and at CROs), within the Clinical Team.

Works with Data Management Community globally to share experience and propose recommendations for change to improve the Data Management process and implements agreed changes across the project thoroughly and consistently.

Maintains oversight and optimizes Data Management consistency and application of standards across studies within a project.

Provides input for safety and therapeutic area data standards and discusses potential deviations from project and global standards with relevant Standards group or personnel eg. Operations Standards Manager.

Updates the Clinical Team and Project Data Management team on changes in Data Management technologies and processes and adapts the Data Management strategy and plans where appropriate to reflect these changes in compliance with relevant regulations, guidance documents, and SOPs.

Provides input into the creation and review of Data Management related SOPs, best practices, working guidelines and other quality template documents.

Ensures that the Data Management teams comply with ICH/GCP regulations, guidance documents and SOPs. Who you are: You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

· University degree or equivalent.

· Strong leaderships skills developed through leading global data management teams through all stages of clinical studies and high-lighted by a consistent achievement of team delivery against commitments and goals.

· Experienced project manager, having led the development and implementation of risk management plans and resourcing plans for the data management activities of studies.

· Proven experience of all aspects of data management including study start up: coordinating case report form design, database set up, validation programming and creating data quality plans, through to database lock, clinical evaluation and statistical analysis.

· Understanding of thesaurus management, serious adverse event reporting, full query management and status reporting.

· Knowledge of relational databases and experience using Clinical Data Management systems and tools - preferably Oracle Clinical.

· Knowledge of global regulatory requirements such as ICH GCP and CFR 21 part 11.

· Proven experience of vendor/CRO management and/or EDC preferable.

· Experience of influencing and negotiating at all levels to achieve team delivery.

· Self-motivated and achievement driven.

· Excellent written and verbal English communication skills demonstrated by ability to present clear messages from complex information/data to all levels in the organisation.

The next step is yours. To apply online today and to learn about other exciting positions, please visithttp://careers.roche.com Roche is an Equal Opportunity Employer

Please refer to Job code offmanroche-00012062 when responding to this ad.

For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/1691491.html?source=ng to apply online.

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