Lead Central Monitor

Key Responsibilities:

• The Lead CM may also have trial’s role: During trial start-up, this role will be involved for the protocol development process to support risk identification, risk assessment, risk oversight (ex: Key Risks Indicators -KRIs-) in partnership with the Risk Surveillance Lead (RSL). This role may also contribute to the establishment of trial-specific KRIs, as needed. During trial execution, the Lead CM will also be responsible for overseeing the CMs’ ongoing risk review, checking of the study data, and detection of risks utilizing technology (the CM platform) to monitor data quality, patient safety, and relevant risks. The lead CM will oversee the process whereby data are translated into signals and insights and communicated to the Clinical Trial Teams (CTTs) for review and decision making to investigate and act appropriately.
• This role is critical for the oversight of CM’s detection of study-related risk/issue(s) within the scope of study RBM strategy. CM Establishment o Support the establishment and implementation of a CM function at Novartis, including processes, tools, and governance frameworks to support RBQM.  Contribute to the CM resourcing strategy, including hiring, onboarding, development, and retention of CM Team. Contribute to the Establishment and actively monitoring of CM objectives.
• Team Leadership and Oversight: Manage and mentor a team of CMs, fostering professional development, ensuring alignment with CM processes, and maintaining high performance across the team. Serve as the primary escalation point for CMs, providing guidance on complex risk signals and ensuring timely resolution of critical study-related risks.  Partner with the CM Head to set, refine and implement the CM strategy, contributing to the continuous improvement of Risk-Based Monitoring (RBM) processes across the organization. Lead efforts to harmonize CM practices across studies, ensuring consistency in risk detection, assessment, and escalation protocols.  Set, refine and implement CM strategy tailored to the associated risks within the assigned DU. Oversee the analysis and interpretation of CM dashboards and data visualization tools to identify and contextualize risk signals and ensure accurate root cause analysis and mitigation actions. Collaborate with cross-functional study teams, including RSL, Study Leaders, Data Managers, and Clinical Scientific Leaders, to ensure robust risk mitigation plans and issue resolutions are in place and effectively executed.
• Provide strategic input during protocol development and study setup to ensure comprehensive risk identification and alignment with RBQM objectives and processes.  Advise on the design and optimization of KRIs and thresholds to enhance the efficacy of CM efforts.
• Ensure appropriate trial data surveillance to deliver quality and integrity of the trials’ clinical data. Act as the primary liaison between the CM team and CTTs and to RSL for Critical to Quality (CtQ) risk management, ensuring clear communication and alignment on risk management priorities. Ensure that CTT risk review meetings are performed in a timely and quality manner within the assigned DU, and ensure stakeholders are informed of key risks, actions, and resolutions. Participate in the periodic CtQ risk review meeting led by the RSLs. Partner closely with the Data Analysts to ensure the CM technology is appropriately configured on trial level.
• The Lead CM is accountable for the Trial Monitoring Plan, ensuring the plan addresses standard as well as trial-specific risks. Performance Tracking and Continuous Improvement: Monitor and report on the effectiveness of CM activities, identifying opportunities for process improvements and driving implementation of enhancements and lessons learned to improve the RBQM (QbD and CM) mitigation strategy. Meaning at the IQRMP development using the lessons learned to improve and suggest additional or more effective mitigation strategy linked to CM. Share insights and lessons learned across teams to build organizational capability in RBQM.
• Ensure comprehensive documentation of CM activities, including risk identification, escalation, and resolution, to meet regulatory and internal quality requirements.  Oversee audit readiness of CM processes and outputs, supporting inspections and ensuring compliance with regulatory standards. Contribute to the improvement of RBQM (both QbD and CM) mitigation strategy. Contribute to IQRMP development using the lessons learned to improve mitigation strategy linked to CM. Act as a key stakeholder in the evaluation, adoption, and improvements of the CM tools and technologies, ensuring effective integration into workflows. Drive innovation in the use of analytics, visualization, and data-driven techniques to enhance risk identification and monitoring capabilities.
• Strong communicator and presenter (oral and written), ability to communicate with Leaders, and influence without authority.  Demonstrated transformational and servant leadership capabilities with ability to role model agile leadership, to experiment and embrace change. Aptitude for data analytics and critical thinking skills to determine the signs of risk. High degree of accuracy and attention to detail. Self-driven and ability to work with limited supervision; delivering results with high quality and on time. Effective management of direct reports, conducting performance reviews and creating plans for talent retention and development (when applicable). Proven ability to coach, mentor, and motivate others. Excellent problem-solving, negotiation and conflict resolution skills.  Demonstrated planning and project management skills (success in planning and executing cross functional projects). Demonstrated leadership in innovation for processes, technologies and way of working, with a focus on sustainable and scalable solutions. Digital Savviness. Lead and inspire diverse work teams across global locations, ensuring alignment with organizational goals and driving program excellence.

Essential Requirements

• 5-8 direct reports (Central Monitors)
• University degree in life science, business or operations; Advance degree preferred Fluent in both written and spoken English
• ≥ 7 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs.
• Strong clinical experience with excellent understanding of clinical trial development and risk management processes and the management of clinical trials (including trial design, protocol development, study start-up, patient recruitment and study close-out).
• Specific Central monitoring / monitoring experience (hands-on experience with Key Risk Indicators -KRIs- review, centralized monitoring and quality tolerance limits -QTLs-) are strongly preferred,
• Experience in implementing or working within Risk-Based Quality Management (RBQM) and adaptive monitoring frameworks • ≥ 3 years of recent experience in people management and/or team leadership
• ≥ 5 years comprehensive experience in monitoring (central, site), clinical data analytics, data management activities or equivalent., and accuracy.
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities, and Novartis standards.

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message