Manager, Standards & Compliance I

Compliance Manager Clinical Process Compliance is accountable for the interpretation and application of GCP compliance and quality principles as they relate to clinical trial execution. Responsible for facilitating impact assessments of regulatory intelligence working with business partners to translate regulations and requirements into execution of high quality clinical trial conduct.  Acts as Primary Point of Contact for all GCP compliance-related questions and issues leading the clinical trial issue escalation process to mitigate serious issues cross-functionally across R&D. Manages capture and closure of issues risk assessments potential non-conformities and non-conformities and effectivity checks. Provides GCP compliance support for site and sponsor inspections and process and system audits. Supports Clinical Trial Business Continuity (BCT) efforts across R&D during times of crisis.  Demonstrates excellence in collaboration communication and working in a matrixed environment.

Responsibilities:

• Responsible for compliance with applicable Corporate and Divisional policies and procedures.
• Provides management of clinical compliance quality and standards projects within Clinical Operations; prepares key performance indicators.
• Provides input on new/updates to SOPs guidelines work instructions as well as make initial gap assessment of impact of new regulations.
• Effectively communicates project progress/compliance concerns and actively identifies issues that potentially impact evaluable study data ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues.

Qualifications :

• Bachelors degree (or ex-US equivalent) is required; advanced degree preferred
• 6 years of pharmaceutical healthcare or clinical research related experience.
• Demonstrates exceptional analytical and critical thinking skills consistently employing a logical and systematic approach to problem-solving and decision-making.
• Demonstrates a comprehensive understanding of the organizational vision and mission and its direct relevance to the Clinical Process Compliance service model.
• Demonstrates a solid understanding and proficiency with AbbVies Quality Manual principles standard business procedures and GCP-related regulations.
• Demonstrates good communication skills in effectively navigating complex and sensitive situations through tactful and strategic communication with cross-functional partners.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

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