Clinical Trial Transparency & Disclosure Manager (On-site/Hybrid)
Description
The Clinical Trial Transparency and Disclosure Manager oversees Clinical Development Operations (CDO's) adherence to the US federal regulation, Physician Payments Sunshine Act (PPSA), specifically as related to clinical studies managed by CDO. This role is responsible for driving the quality, compliance, completeness and timeliness of CDO's reporting outputs to the US Compliance and Integrity function, through alignment with US CDO leadership and cross-functional stakeholders, to ensure CDO meets the PPSA US regulatory obligation. In addition, it ensures that reporting processes are conducted in compliance with company SOPs, local working instructions, and business ethics.
This role requires a strong, solid understanding of and experience with the subject matter, including ability to create and deliver related training to both internal and external business partners as well as it must be able to establish and maintain collaborative working relationships with internal stakeholders (including and especially Clinical study teams) as well as external third-party vendors.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
• Drive the organizational readiness, operational oversight and strategic direction of US Open Payments Reporting, as related to clinical studies managed by CDO.
• Expertise in subject matter, to comprehend and act upon the nuances of the PPSA and its requirements for a Sponsor involved in clinical trials. Able to identify the many and varied types of reportable transfers of value (TOVs) that may be incurred related to clinical trials, and/or aligns with Compliance & Integrity partners as needed on BI's determination of reportability.
• Coordinate with third parties to ensure external deliverables meet with internal expectations, providing training as needed.
• Effectively communicates to a broad spectrum of interfacing stakeholders and proactively communicates to Leadership and/or impacted stakeholders if risks to deliverables are identified.
• Drives efficiencies in processes and tools, pragmatically challenging where appropriate, with the aim of eliminating waste in effort and resources whilst still delivering on BI and federal requirements.
• Appropriate oversight and guidance of, and delegation to allocated resources supporting the US Open Payments Reporting process for CDO, within US CDO Business Operations.
• Thinks critically and analyzes data to influence decisions, identify risks and improvement opportunities, and distill complex issues into actions plans.
• Ability to build positive relationships across functions to meet a unified business objective. Navigates complex organizational structures with varying objectives and still meets the business needs.
Requirements
• Bachelor's degree with 5 years related working experience preferably in PPSA research reporting OR Master's degree with at least 3 years related working experience preferably in PPSA research reporting.
• Strong understanding of pharmaceutical industry transparency and disclosure requirements and regulations, and the ability to apply them to BI's internal processes.
• Proficient in Microsoft Office with advanced skills in Excel and strong understanding of Access databases preferred.
• Experience working in an aggregate spend/transparency reporting system (i.e. AGS360, ITR, TRACE, etc), preferably related to Research Payments reporting.
• Experience in obtaining, reviewing and analyzing documentation and data from various sources.
• Demonstrated data entry and record keeping skills (accuracy and completeness) in systems/databases.
• Familiarity with Anti-Bribery and Anti-Corruption (ABAC) and Fair Market Value (FMV) policies preferred.
• Experience in project management, preferably with the ability to manage multiple projects/assignments concurrently.
• Detail-oriented with demonstrated planning and organization skills preferred.
Eligibility Requirements:
• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.
Compensation
The base salary range for this position is $115,000 to $181,000. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here .
The Clinical Trial Transparency and Disclosure Manager oversees Clinical Development Operations (CDO's) adherence to the US federal regulation, Physician Payments Sunshine Act (PPSA), specifically as related to clinical studies managed by CDO. This role is responsible for driving the quality, compliance, completeness and timeliness of CDO's reporting outputs to the US Compliance and Integrity function, through alignment with US CDO leadership and cross-functional stakeholders, to ensure CDO meets the PPSA US regulatory obligation. In addition, it ensures that reporting processes are conducted in compliance with company SOPs, local working instructions, and business ethics.
This role requires a strong, solid understanding of and experience with the subject matter, including ability to create and deliver related training to both internal and external business partners as well as it must be able to establish and maintain collaborative working relationships with internal stakeholders (including and especially Clinical study teams) as well as external third-party vendors.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
• Drive the organizational readiness, operational oversight and strategic direction of US Open Payments Reporting, as related to clinical studies managed by CDO.
• Expertise in subject matter, to comprehend and act upon the nuances of the PPSA and its requirements for a Sponsor involved in clinical trials. Able to identify the many and varied types of reportable transfers of value (TOVs) that may be incurred related to clinical trials, and/or aligns with Compliance & Integrity partners as needed on BI's determination of reportability.
• Coordinate with third parties to ensure external deliverables meet with internal expectations, providing training as needed.
• Effectively communicates to a broad spectrum of interfacing stakeholders and proactively communicates to Leadership and/or impacted stakeholders if risks to deliverables are identified.
• Drives efficiencies in processes and tools, pragmatically challenging where appropriate, with the aim of eliminating waste in effort and resources whilst still delivering on BI and federal requirements.
• Appropriate oversight and guidance of, and delegation to allocated resources supporting the US Open Payments Reporting process for CDO, within US CDO Business Operations.
• Thinks critically and analyzes data to influence decisions, identify risks and improvement opportunities, and distill complex issues into actions plans.
• Ability to build positive relationships across functions to meet a unified business objective. Navigates complex organizational structures with varying objectives and still meets the business needs.
Requirements
• Bachelor's degree with 5 years related working experience preferably in PPSA research reporting OR Master's degree with at least 3 years related working experience preferably in PPSA research reporting.
• Strong understanding of pharmaceutical industry transparency and disclosure requirements and regulations, and the ability to apply them to BI's internal processes.
• Proficient in Microsoft Office with advanced skills in Excel and strong understanding of Access databases preferred.
• Experience working in an aggregate spend/transparency reporting system (i.e. AGS360, ITR, TRACE, etc), preferably related to Research Payments reporting.
• Experience in obtaining, reviewing and analyzing documentation and data from various sources.
• Demonstrated data entry and record keeping skills (accuracy and completeness) in systems/databases.
• Familiarity with Anti-Bribery and Anti-Corruption (ABAC) and Fair Market Value (FMV) policies preferred.
• Experience in project management, preferably with the ability to manage multiple projects/assignments concurrently.
• Detail-oriented with demonstrated planning and organization skills preferred.
Eligibility Requirements:
• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.
Compensation
The base salary range for this position is $115,000 to $181,000. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here .