Senior Manager, Research Compliance

The Research Compliance Senior Manager will be responsible for ensuring that all research activities within the organization comply with applicable regulations and guidelines. This role requires you to bring a strong knowledge of research regulations and guidelines, including those related to human subjects- research, research privacy, data management, Institutional Review Board (IRB) practices, and export controls. The manager will oversee compliance with regulatory requirements and liaise with regulatory agencies and bodies such as the Office for Human Research Protections (OHRP), Office of Research Integrity (ORI), and Food and Drug Administration (FDA).

They will develop and implement compliance policies and procedures, monitor and ensure adherence to programmatic research regulations and guidelines.

This senior manager level position is primarily responsible for managing company compliance activities in partnership with internal and external stakeholders and managing strategic compliance initiatives. Responsibilities include managing compliance reporting efforts, compliance investigation, and activities associated with continued regulatory compliance across one or more business functions. Additional key responsibilities include managing the implementation of compliance efforts through monitoring, interpreting, and designing strategy around regulatory changes. This managing level employee also manages projects or compliance components of larger cross-functional projects including identifying and managing stakeholders.

• Pursues professional growth and provides developmental opportunities for others by soliciting and acting on performance feedback; building collaborative, cross-functional relationships; hiring, training, and developing talent for growth opportunities; delegating tasks and decisions; fostering open dialogue amongst departments; strategically evaluating talent for succession planning; setting performance management guidelines and expectations across units; and working closely with employees to set goals and provide open feedback and coaching to drive performance improvement.
• Manages designated units by translating business plans into tactical action items; communicating goals and objectives; ensuring all policies and procedures are followed; overseeing the completion of work assignments; assuming responsibility for decision making; aligning team efforts; building accountability for and measuring progress in achieving results; incorporating resources, costs, and forecasts into unit plans; removing obstacles that impact performance; guiding performance and developing contingency plans accordingly; partnering with key stakeholders and business leaders to ensure products and/or services meet requirements and expectations while aligning with departmental strategies; and influencing units to operate in alignment with business objectives.
• Manages company compliance activities by partnering with internal and external stakeholders; applying established regulations and standards to compliance efforts; managing the design, development, and execution of strategic compliance initiatives; overseeing the analysis of regulations and regulatory changes, and their application to operations; and overseeing the documentation of compliance activities.
• Manages compliance reporting efforts across one or more business functions by managing the evaluation and summary of compliance data, audit information, and potential risks and remedies; identifying and reporting key compliance drivers, liabilities, and performance indicators (for example, adherence to standards, incorporation of new regulations) to senior management; and developing complex presentations to convey key findings to leadership and external business stakeholders.
• Manages compliance investigations across one or more business functions by managing the collection and analysis of quantitative and qualitative data; leading interviews as appropriate; researching key business issues; and evaluating and recommending corrective action plans for substantiated allegations.
• Manages projects or compliance components of larger cross-functional projects by identifying and managing stakeholder contacts; assembling teams based on project needs and team member strengths; developing, analyzing, and managing project plans; negotiating and managing project schedules and resource forecasts; and managing project financials and deliverables.
• Manages activities associated with continued regulatory compliance for one or more business functions by monitoring, interpreting, and designing strategy around regulatory changes; determining the impact of changes to the business; providing direction on implementation of changes throughout the organization; and providing regulatory input before and during inspections to minimize the risks of future non-compliance.
• Manages the implementation of compliance efforts by approving compliance requirements; ensuring the assessment of current state compliance to identify gaps and corrective actions; managing the analysis and development of complex compliance standards, policies and procedures, and training; and ensuring and monitoring ongoing compliance adherence.

Qualifications:

• Ambiguity/Uncertainty Management
• Attention to Detail
• Business Knowledge
• Communication
• Constructive Feedback
• Critical Thinking
• Cross-Group Collaboration
• Decision Making
• Dependability
• Diversity, Equity, and Inclusion Support
• Drives Results
• Facilitation Skills
• Health Care Industry
• Influencing Others
• Integrity
• Leadership
• Learning Agility
• Organizational Savvy
• Problem Solving
• Short- and Long-term Learning & Recall
• Strategic Thinking
• Team Building
• Teamwork
• Topic-Specific Communication

• Analytical Skills
• Compliance Management
• Cross Department Coordination
• Getting Work Done Through Others
• Negotiation
• Project Management
• Technical Communication
• Written Communication

• Minimum three (3) years experience in a leadership role with or without direct reports.
• Bachelors degree in Health Care Administration, Clinical, Law, Public Health, Business or related field and Minimum eight (8) years experience in compliance, health care operations (quality, risk, etc.), audit, finance, regulatory or public policy development, investigations, information security, or insurance/health plan governance or a directly related field. Additional equivalent work experience in a directly related field may be substituted for the degree requirement.

• Five (5) years experience in privacy and security compliance.
• Two (2) years supervisory experience.

Salary : $147,600 - $190,960