Senior Manager, Global Clinical Affairs Data (Hybrid)

Job Title:                        Senior Manager, Global Clinical Affairs Data

FLSA Status:                   Exempt

Position Overview:
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
• Performs other duties as required.

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.
• NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office; may work remotely other days). #LI-Hybrid 

Additional Information:

The US base salary range for this full-time position is $143,325.00 - $214,987.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

(Know Your Rights)