Clinical Process Compliance Manager I
Clinical Process Compliance Manager I
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Salary Not Disclosed
1 Vacancy
Job Description
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 compliancerelated questions and issues leading the clinical trial issue escalation process to mitigate serious issues crossfunctionally across R&D. Manages capture and closure of issues risk assessments potential nonconformities and nonconformities 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.
Manager responsible for the overall assessment of compliance quality control and/or standards defined for the execution of clinical trial(s); including managing CAPA supporting process improvement initiatives and preparing/analyzing metrics. May have direct reports and will matrix manage with assigned therapeutic area or functional partners to ensure proper documentation of AbbVie procedures implementation of process changes ensure compliance and/or execution on timelines and quality deliverables. Is aware of both internal and external business environments assesses impact on the processes for clinical study execution and assists in making modification as necessary. Develops initial interpretation of relevant regulations and guidelines and act as a SME for Clinical Operations. Assist clinical teams with inspections audit responses and consult on root cause analysis as required. Takes initiative to resolve problems and mitigate risk.
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 exUS 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 problemsolving and decisionmaking.
- 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 GCPrelated regulations.
- Demonstrates good communication skills in effectively navigating complex and sensitive situations through tactful and strategic communication with crossfunctional 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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
