Position Summary:
The Sr. Data Management Project Manager is responsible for developing and implementing project plans for outsourced studies, ensuring that the activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the flawless execution of a clinical trial, by acting as the primary Data Management (DM) representative to the study management team.

Primary contact between DM and clinical study management teams. Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and other external vendors to organize and coordinate all aspects of data management for assigned studies.

Directs DM activities in conjunction with the study team, Data Management functional Subject Matter Experts (SMEs) and FSPs. Ensures projects are appropriately resourced and proposes solutions for data management issues that arise during the course of a study.

Accountable for the development and execution of Data Management project plans including timelines/milestones, quality control, database set-up, study conduct and closeout in coordination with other functional groups (i.e., Coding, CRF design, Clinical Data Processing, etc.). Accountable for overall quality of deliverables from DM vendors.

Communicates priority tasks, project needs and changes in project plans or scope with DM study teams (Data Entry, Clinical Systems, CRF Scanning, and contractors) assigned to studies. Manages performance and quality issues with vendors and escalates to vendor managers and Senior Management as appropriate.

Communicates project status, vendor status and vendor performance in relation to both quality and timelines to Vendor Managers and Senior Management. Develops risk mitigation or action plans where appropriate.

Participate in the review of protocols and other study related documents as required.

Assures that data management standards and processes are followed for the studies in charge.

Qualifications:
- 6-8 years in the Data Management field, previous work with CROs and Data Management vendors is required,
working in a global/cross cultural setting is preferred.
- In-depth knowledge and understanding of the drug development process and data management process. Aware
of related Pharma Industry SOPs, guidelines and Best Practices
- Knowledge of GCP and other regulations. Aware of current global regulatory guidelines relevant to Clinical Data
Management.
- Technical/Software Skills: Familiarity with clinical data management system software; General software skills:
Lotus - Notes, MS Access, MS Word, MS Excel, MS Project
- Strong understanding of database programming concepts
- Excellent multi-level, oral and written communication skills and presentation skills.
- Ability to manage multiple programs and processes simultaneously.
- Proven ability to build relationships and manage expectations with CROs and key Data Management service
providers who represent single or multiple functions.
- Internal customer management, influence of peers, team effectiveness and enhancement, timeline
management, proactive problem solving ability, resource planning, ability to develop trust, shared goals and
values.
- Exhibits collaborative, conceptual thinking, systems process thinking, accountability to deliverables milestones,
conflict resolution (internal and external).
- Demonstrates leadership, negotiation and problem-solving skills
- The candidate should be detail oriented, identify issues and assist in problem solving in a timely manner.
- Ability to handle multiple (changing) priorities under tight timelines
- Ability to work independantly with minimal supervision in a fast-paced environment.

About Biogen Idec: Transforming Discovery into Care

With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ:BIIB) is one of the world's leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology. Every day, employees of Biogen Idec make a difference in people's lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.

Learn more at www.biogenidec.com/careers.

Biogen Idec is proud to be an equal opportunity employer

HOW TO APPLY:
Please email resume and requirements to: jay.dietz@biogenidec.com