Global Clinical Operations- CRA Manager

Key responsibilities:

• In collaboration with SSO Clinical Project Manager (CPM), supports recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities

• Is accountable for monitoring quality, timely data entry and issue resolution

• Ensures CRA monitoring competency gaps are identified and resolved through targeted training curricula in collaboration with training group as well as by performing co-monitoring visits with training purposes
• Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
• Actively manage CRA team performance including implementation of development and performance improvement plans
• Supports implementation of Risk Based Monitoring in GCO clinical trials by coaching and training CRAs on process thinking, risk-based monitoring concept and related systems
• Is responsible for execution of annual CRA oversight visit plan to assess ongoing CRA monitoring competency, identifying issues, and developing resolution strategies
• Collaborates with CPM for monitoring trends that require targeted training and/or development of CRAs to deliver to trial and quality KPIs
• Collaborates with MSOM for country resource strategy
• Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Supports Clinical Development Audits, site audits and inspection and ensures CAPA follow-up and implementation for CRA and site identified issues
• Manages CRA adherence/compliance to SOPs and required training curricula
• Is responsible for the hiring, training, development, and retention of a team of CRAs executing Phase I-IV Global Drug Development (GDD) trials
• Performs ongoing assessment and allocation of monitoring resources within countries to ensure balanced CRA workload for quality monitoring
• Ensures CRAs have the required level of monitoring and disease area knowledge and skills to successfully deliver to protocol requirements
• Monitors, tracks and approves CRA travel and expense to ensure compliance to T&E policy and budget

Band

Level 4

Job Description Summary

To lead Patient Safety operational processes at the Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of Novartis group approved, marketed and investigational products (incl. drugs, food supplements and medical devices).

Job Description

Key responsibilities:

• Manage a team of PS Associates (such as PS Specialists, PS Senior Specialists and/or PS Managers) in line with the country PS organizational structure and PS strategy in place.
• Act as qualified delegate of the Local Qualified Person for Pharmacovigilance/ Local PV Responsible Person in Novartis Country Organization, as defined by local regulation and applicable legislation, in terms of ensuring compliance of adverse drug reactions monitoring and submission.
• Act as qualified delegate of the Country Patient Safety Head in terms of operational vigilance processes.
• Ensure robust oversight and compliance in terms of reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN, SUSAR, PSUR, DSUR, changes in risk-benefit profile) to Local Health Authorities (LHA) according to regulatory requirements and Novartis procedures.
• Work in close collaboration with other local and global medical safety functions to ensure accurate evaluation of safety data.
• Interact and exchange relevant safety information with Health Authorities, other functional groups, third-party contractors, and PS associates, as applicable.
• Monitor national pharmacovigilance regulations and provide update to global PS organization.
• Set up, update, and implement local procedures to ensure compliance with PS global procedures and national requirements.
• Ensure local PS-related RMP commitments are executed and properly documented
• Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.
• Act as a key partner who provides input, during the process of establishing local programs (ex. POPs, DEAs; SM/SML, etc.): comments on proposals for vigilance language, content, and establishment of necessary controls on collection and reporting of adverse event information.
• Ensure that relevant local literature articles are screened, as appropriate.
• Supervision of management and maintenance of all relevant PS databases.
• Ensure timely preparation and submission of KPI reports on AE reporting and AE follow-up attempts including identification of root cause(s) e.g., for late reporting to HA, missed or delayed follow-up attempt, development and implementation of corrective and preventative action(s) as needed.
• Support in developing and updating training materials for pharmacovigilance and ensure training of Country Organization associates on relevant PS procedures for AE reporting, including field force and third-party contractor, if applicable.
• Ensure support for and close-out of audits, corrective action plan, investigation, and Health Authority inspections.
• Ensure selection, and recruitment of qualified PS team members and their further professional development.
• Ensure training and oversight of commissioned staff, as applicable.
• Contribute to the preparation and update of the local Pharmacovigilance System Master File as per regulation and related procedures.
• Other agreed tasks assigned by manager.

Essential requirements:

• A degree in scientific or health discipline required and advanced degree preferable (or, for United States: 4-year degree plus relevant, related healthcare experience)
• Fluent in both written and spoken English
• Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials
• Experience in project management and evidence of team leadership capabilities
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution

Desirable requirements:

• Decision making capability
• Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.
• Excellent coaching capability to best support CRA in driving right mindset and behavior
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations, risk-based monitoring and Novartis standards
• Demonstrated negotiation and conflict resolution skills
• Fast change adaptability to best partner & influencing with sites on fast changing landscape
• Trust and rapport building is a very important skill needed
• Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
• Good communication skills, ability to influence others & Relationship management
• Excellent communicator and presenter (oral and written)
• Ability to manage sites independently; Proven ability to work independently with minimal supervision
• Good analytical thinking
• Ability to anticipate potential issues and take appropriate actions with or without supervision
• Digital & tech capabilities