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.
Key Responsibilities Include:
- 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.
- Provides leadership for the development, implementation and maintenance of global process expectations and global Quality Documents
- Provides consulting support in development of training, tools and templates, provide technical interpretative guidance of clinical regulations to the clinical research community.
- Strategically prioritizes projects and align resources to the goals and activities within Development.
- Assesses risk of issues raised by management and staff and understands the potential impact on operational and quality requirements and project timelines. Elevates issues to appropriate personnel and works to develop a resolution.
- Supports and represents Development Operations during audits and inspections conducted by regulatory authorities.
- Effectively communicates with senior and multiple other levels of management and business staff.
- Development and maintenance of QUEST
- Presenting at various training forums; sending organizational broadcasts of process/ procedural changes and Clinical Standards webpages.
- Remain current in clinical regulations, AbbVie policies, and new regulations affecting clinical research to ensure the Development systems, processes, and procedures appropriately reflect current global standards. Maintain awareness of industry practices.
- Works broadly and collaboratively across other functional areas and AbbVie divisions on initiatives related to quality, clinical activities, SOP development, audit and inspection commitments, etc.
- Creates a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.
- Supports a global clinical quality control program to assess real-world application of global procedures and policies in the conduct of global clinical studies.