Senior Manager, Global Clinical Affairs Data (only w2 candidates, No c2c, no 1099)

Title: Senior Manager, Global Clinical Affairs Data (only w2 candidates, No c2c, no 1099)

Job ID: 403

Duration: 6+ Months

Location: Remote

Description:

The Senior Manager, Global Clinical Affairs Data is responsible for the management of data for all global studies. This includes identifying sources of data, data collection, data processing, data flows, data privacy, data integrity, and data distribution. The Senior Manager, Global Clinical Affairs Data is also responsible for summarizing the data analysis and collaborating in writing a formal report for regulatory agencies.

Responsibilities:

• Identify and manage sources of data, identify efficient data collection pathways, manage data processing, identify and manage data flows, collaborate cross-functionally to ensure data privacy, manage data integrity by implementing quality control checks to ensure accuracy, troubleshoot data issues, and data distribution for all global studies
• Performing User Acceptance Testing of clinical databases
• Liaise with the biostatistician to ensure alignment on data collection and analysis
• Collaborate on study close-out activities and manage the database lock
• Ensure all adverse event documentation is sufficiently detailed to facilitate adjudication
• Collaborate cross-functionally to obtain all study data related to an adverse event
• Manage communication of all adverse event reporting to the Medical Monitor or Data Safety Monitoring Board when applicable
• Manage the finalization of the report shell in collaboration with Medical Affairs
• Summarize the data analysis and collaborate to write a formal report for regulatory agencies
• Manage the distribution of data to clinical sites after the completion of a study
• Manage data retention for each study according to internal processes and regulations
• Define and manage internal data management processes for all global studies
• Develop data management plans for all global studies

Education and Experience:

• Bachelor s degree and/or an equivalent combination of education or experience.
• Minimum of 10 years of relevant experience in the field.
• Must have analytical skills, be detail-oriented, and have good interpersonal skills.
• Knowledge of agency guidelines and requirements.

Skills/Competencies:

• Excellent written and effective verbal communication skills.
• Ability to communicate cross-functionally across the organization.
• PC skills; word processing, spreadsheet, database, Internet search and utilization.
• Flexible and able to work in a fast-paced environment.
• Team player.
• Ability to organize and judge priorities.
• Excellent ability to generate and maintain accurate records