Program Manager (Reporting, Archiving and Mapping) Hybrid

Job Description

Primary activities include but are not limited to:

• Serves as a Subject Matter Expert in Clinical Programming supporting study build reporting and analytics. Leads efforts to standardize simplify and optimize processes through best practices and continuous improvement initiatives.

• Provides technical leadership and oversight for Clinical Programming (including reporting and analytics) deliverables across programs including review of eCRFs required specification understanding of Protocol In-Life Report specifications and library development. Ensures compliance with established standards SOPs and process guidelines while proactively managing timelines and escalating risks related to reporting assets and data flow.

• Partners closely with study teams Leadership and external vendors to translate study requirements into high-quality solutions and aligned technical approaches. Provides clear technical direction and ensures consistency across deliverables supporting business needs along with proper facilitation.

• Supports the development of team members through technical mentoring training and participation in hiring and performance feedback. Ensures adherence to standards in the development documentation and maintenance of libraries.

Qualifications Skills & Experience

• Bachelors degree in computer science or equivalent educational exposure to software design procedure language development theory and techniques testing methodologies and software documentation along with Pharma skills.

• Minimum of 7 years experience in technology acquisition and implementation focused on data transformations data flow data loading and reporting writing (e.g SQL PL-SQL Java /DMWVeevaDatabricks Python Legacy SAS etc) along with AI related Claude Code tools).

• 4 years of project management experience. (Either one project for a year or multiple projects.)

• Demonstrates a high level of understanding with the design and development of electronic Case Report Forms (eCRFs) clinical databases and other methods of capturing and transferring data clinical database development tools ETL tools reporting tools standards and the development process in support of clinical research.

• Knowledge of Electronic Data Capture Systems or Data Management Systems

• Solid knowledge of MS Windows/Office software and exposure to web-based applications.

• Ability to establish and maintain good working relationships with different functional areas.

• Strong sense of urgency and customer focus.

• Possesses excellent communication skills and interacts effectively with Study Team.

• Strong organizational time management and multi-project coordination skills.

• Broad knowledge of Clinical Development and Regulatory Affairs requirements.

• Ability to multi-task work independently and good communication skills.

• Understanding of drug discovery process FDA regulations GxP guidelines ICH guidelines clinical database cleaning process and 21 CFR Part 11.

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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