The Clinical Data Manager will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies. Provides Data Management leadership and expertise to project and study teams. Will have a good knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidances (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval. Responsible for managing data management components of project and study budgets and vendor performance. May mentor team members and more junior staff and may direct activities of contract Data Manager staff.
Delivering Excellence: Takes leadership role in project implementation
• As a member of the clinical study or project team, ensures oversight of the Data Management external service providers; provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the external service provider
• Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization
• Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of data deliverables according to internal and regulatory standards
• Works with team members via matrix relationships (internally or at external service providers) by directing work, resolving problems and/or providing guidance
Accountability and Ownership: Drives accountability at every possible level
• Ensures Data Management external service providers are delivering quality data and documentation on time, on budget and to Shire's quality standards and SOPs
• Reviews Data Management external service provider performance measures and evaluates cost/benefit of actions taken to remedy or improve performance
• Collaborates with external service provider and study team members to identify and resolve issues impacting goal attainment.
Judgment and Decision Making: Evaluates immediate business impact and takes decisive action
• Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve
• Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results
Courage to challenge: Takes risks and challenges norms to support tomorrow's needs
• Supports consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to Data Management
Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer's decision making
• Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines
• As Data Management lead to the clinical study, becomes involved in decision making processes to ensure maximum performance of the team. Provides Data Management expertise to the teams in customer oriented point of view
• Leads development of Data Review and Oversight Plans; contributes to other key study level documents (e.g. protocols, SAPs)
Building Authentic Relationships: Building trusting relationships that will enhance current and future needs
• Leads in developing trust through transparency in communication and individual actions; ensures outcomes are team driven rather than individually driven; promotes collaborative team and organizational success
Education & Experience Requirements:
• B.S. degree in Scientific or related field is preferred
• Minimum of 5-7 years as a Sr. Data Manager within a Data Management organization
• Experience with leading teams and/or organizations
• CCDM certification preferred
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.