Senior Manager/Associate Director, Clinical Data Management
Job Description Lexicon Pharmaceuticals is currently recruiting for an experienced and highly motivated Senior Manager/Associate Director, Clinical Data Management to join our team. This role can be based in our Woodlands, Texas or Basking Ridge, New Jersey locations or can be worked remotely The Senior Manager/Associate Director, Clinical Data Management will be responsible for planning, project management, and task coordination services for our Biostatistics and Data Management functions. The position will effectively work within the department as well as with the broader matrix organization to ensure the tracking and timely routing of all assigned project deliverables for Biostatistics and Data Managements. Key Responsibilities include but will not be limited to:
Maintain and manage all Biostatistical and Data Management deliverable timelines across all projects. Partner with Senior Management to establish timelines for required deliverables and intermediate milestones for all projects. Partner with senior Biostatistics leadership in determining resource needs and capacity planning. Maintain all tracking of work in progress against milestones and escalate resource constraints and risks regarding quality or timeliness. Support Biostatistics and Data Management vendor contracting, tracking of vendor work product, and review of invoices against expected work. Review Scopes of Work and Assumptions documents related to Biostatistics (including SAS Programming), and Data Management deliverables to ensure they are accurate and complete. Participate in program planning and management meetings as the representative for Biostatistics and Data Management. Ensure ongoing communication with internal/vendor Program Managers to ensure integration with wider project timelines and goals. Oversee organization and maintenance of Biostatistics and Data Management work products and associated documentation and ensure that records are appropriately filed in Trial Master File (TMF) or other validated systems agreed upon and specified in the TMF plan. Required Experience
Qualifications:
A Bachelors' Degree in a Scientific or Healthcare related field is required. A minimum of 10 years' experience in Clinical Data Management in the pharmaceutical or contract research organization industries. A minimum of 5-8 years' experience in program management. A strong understanding of Biostatistics and Data Management process, deliverables and activities. Excellent organization and communications skills. Ability and desire to work in a team-oriented environment. Hands on experience with the Microsoft Office products, including software used for project planning activities.
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Maintain and manage all Biostatistical and Data Management deliverable timelines across all projects. Partner with Senior Management to establish timelines for required deliverables and intermediate milestones for all projects. Partner with senior Biostatistics leadership in determining resource needs and capacity planning. Maintain all tracking of work in progress against milestones and escalate resource constraints and risks regarding quality or timeliness. Support Biostatistics and Data Management vendor contracting, tracking of vendor work product, and review of invoices against expected work. Review Scopes of Work and Assumptions documents related to Biostatistics (including SAS Programming), and Data Management deliverables to ensure they are accurate and complete. Participate in program planning and management meetings as the representative for Biostatistics and Data Management. Ensure ongoing communication with internal/vendor Program Managers to ensure integration with wider project timelines and goals. Oversee organization and maintenance of Biostatistics and Data Management work products and associated documentation and ensure that records are appropriately filed in Trial Master File (TMF) or other validated systems agreed upon and specified in the TMF plan. Required Experience
Qualifications:
A Bachelors' Degree in a Scientific or Healthcare related field is required. A minimum of 10 years' experience in Clinical Data Management in the pharmaceutical or contract research organization industries. A minimum of 5-8 years' experience in program management. A strong understanding of Biostatistics and Data Management process, deliverables and activities. Excellent organization and communications skills. Ability and desire to work in a team-oriented environment. Hands on experience with the Microsoft Office products, including software used for project planning activities.
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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