Job Description

Lets do this. Lets change the world. In this vital role you will be a Data Manager within Biosimilars Data Management within Global Development. The Biosimilars Development uses a fully outsourced business model, partnering with CROs. The Data Manager taking this role will partner with cross functional study teams as well as the CRO partner to ensure product delivery of the Biosimilars portfolio.
Biosimilars Data Management designs, plans and implements the capture, cleaning and storage of all clinical study and trial management data and maintains the CRO partnership Sharepoint sites.
Specific responsibilities include but are not limited to: • Project level coordination and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines.
• Ensure that quality control checks are occurring such that quality databases are delivered and batch cleaning SLAs are conducted as per contract.
• Review and approve study specific training and lead vendor results and relationship at the study level.
• Communication of project level issues including processes, timelines, resourcing, performance, etc.
• Review of all study level non-DM documents for awareness and project level consistency.
• Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level.
• Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.
Basic Qualifications:
Doctorate Degree
Or
Master's Degree and 2 years of clinical experience
Or
Bachelor's Degree and 4 years of clinical experience
Or
Associate's degree and 8 years of clinical experience
Or
High school diploma/GED and 10 years of clinical experience
Preferred Qualifications: • Degree in life science, computer science, business administration or related field.
• Clinical Data, Project and Planning Management experience in the Pharmaceutical or Biotech industry.
• Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.).
Knowledge

• Knowledge of relevant therapeutic or product area
• Clinical research experience obtained working on industry-sponsored global clinical trials
• Excellent oral and written communication skills
• Proven ability to lead, manage, and motivate others in a complex, multi-functional environment
• Experience working in a global, matrix organization on global clinical development programs
• Knowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert advice
• Broad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines
• Solid understanding of Biopharmaceutical/Healthcare Compliance
• Proven ability to anticipate and resolve problems
• Excellent interpersonal and organizational skills
• Professional collaboration and leadership skills
• Experience anticipating and resolving problems
• Experience writing and presenting clearly on scientific and clinical issues
• Experience collaborating and leading cross-functional teams

• Team leadership
• Strong written and oral communication
• Flexibility
• Initiative
• Problem solving
• Project management
• People management
• Decision making
• Scientific/technical excellence

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