Global Process Control Manager, Trial Monitoring (Remote)

Job Description

Leading global quality process improvement and providing oversight and control of quality and compliance activities for 3,000+ global Trial Monitoring associates.

The Process Control Manager is responsible for process control and improvement in TMO, focused on Good Clinical Practices (GCP). The role works collaboratively across the Monitoring Organization and with CQA to ensure improvement of quality and completion of risk management activities. The PCM conducts reviews of GCP audit and inspection findings to identify trends and systematic gaps in the monitoring processes. Tracks progress to Key Performance Indicators (KPIs) that impact quality, Quality Plan and overall compliance to applicable monitoring processes, regulations and training requirements. Facilitates the development and implementation of quality improvement initiatives within the Monitoring Organization; ensures process changes are adequately communicated and managed; inputs into the development of new processes and SOPs that contribute to sustainable quality.

Your responsibilities include, but not limited to:

• Metrics and Quality Key Performance Indicators – Supports the implementation and tracking of compliance to the established clinical trial processes. Responsible to analyze, track, report and reinforce adherence to applicable performance measures. Recommends corrective actions based upon report outputs; implement training as applicable to redirect teams to better KQI scores.
• Tracks audit and inspection findings, reports on results, tracks trends, generates lessons learned. Drives Risk Mitigation Assessment process to improve the rate of compliance of countries to TMO quality standards.
• Process Expertise – serves as subject matter expert and input into new SOPs on behalf of TMO, ensures compliance to and adequate training opportunities for new SOPs and Business Guidance. Tracks deviations from Monitoring SOPs and ensures appropriate documentation is filed and corrective actions are taken. Identifies procedural gaps and drives correction with process improvements where applicable.
• Conducts and supports vendor qualifications as needed; documents and files qualification evidence appropriately.
• Process Compliance – Ensures CAPA commitments are adequate, submitted and completed in a timely manner. Ensures audits and inspections are supported, tracked and outcomes requiring corrective action are managed. Reviews CAPAs and makes appropriate recommendations to keep consistent actions across TMO. Initiates and documents root cause investigations of critical issues in collaboration with Quality Assurance and Clinical Operations. Supports the generation and dissemination of Tactical Memos and Lessons Learned communication in collaboration with monitoring training. Leads the conduct of Trial Master File quality control checks.
• Ensures TMO compliance with required training by tracking and reporting compliance status for the Global, Regional and Country level organizations. Identifies gaps and assign action where needed to promptly gain compliance.
• Inspection Readiness – Supports inspection preparation and execution as well as inspection readiness. Supports registration trial readiness by leading the conduct of an annual self-assessment and spot checks for TMO in conjunction with that being done at the study level by the clinical team. Escalates issues to TMO management and CQA in a timely manner. Ensures that actions required of TMO are appropriately taken. Ensures procedural deficiencies within TMO are corrected and prevented. Liaises with Regional Process Control Managers as well as Trial Monitoring Quality Managers to ensure local TMO quality is acceptable.

EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum requirements

What you’ll bring to the role:
o College or University degree is required with significant life science experience; Advanced degree in life sciences is preferred
o A minimum of 5 years in a R&D regulated environment in a relevant pharmaceutical or health care company is required
o Clinical operations experience is preferred
o Experience in ICH-GCP Process Control or ICH-GCP Quality Assurance systems and Health Authority regulations; Clinical Operations experience in these areas is preferred
o Demonstrated ability for leading initiatives with cross-functional teams and implementation of recommendations
o Experience working in matrix environment and in global teams

** This position can be based remotely anywhere in the U.S. (there may be some exceptions based on legal entity registration). Please note that this role would not provide relocation as a result. The preference is for the candidate to work eastern time zone hours
*** The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 25% travel.


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We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

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