Boehringer Ingelheim Jobs

Basic purpose of the job

As part of Clinical Development & Operations (CD&O) team the Site Monitoring Lead (SML) is a key member of global Clinical Trial Team nominated to a specific trial within the Evidence Network. SMLs are accountable for authoring the monitoring risk assessments and plans, ensuring sponsor oversight, trend analysis, signal detection and delivery of their assigned trial(s) in close collaboration with the CRO partner to ensure delivery of BI’s pipeline through accurate planning and efficient execution of Site Monitoring in trials that bring speed & value to participating subjects and sites.

The SML provides Site Monitoring expertise to and consults the Trial Team, leads and oversees the implementation of the Site Monitoring & Oversight approach and activities as part of overall clinical trial quality management. SML contributes to the overall success and delivery of their assigned clinical trial(s)in all R/OPUs according to defined milestones and key performance indicators (e.g. Medicine Excellence KPIs -MedEx).

The SML is accountable for managing the trial level planning, implementation, issue management, and oversight of the Site Monitoring activities of a trial as assigned, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, BI sponsor obligations, ICH-GCP and applicable regulations and ensure inspection readiness at all times.

Accountabilities

・Trial Preparation:

• Plan trial quality and risk monitoring/ mitigation as part of the Trial Team.

• Deliver Risk-based Site Monitoring approach and training for the trial. Accountable for the development of the operational Site Monitoring & Oversight plans.

• Develop and provide appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA).

• Participate in development of trial level documents.

• Behave as expert and consultant on Site management and monitoring topics.

• Integrate patient/site level feedback to the documents ensuring design with a focus on the patient.

• Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings.

• Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee)

• Facilitate communication and direction with CT Managers and CRO CRAs.

Related performance indicators

Delivery of clinical trial according to defined milestones and Med-Ex key performance indicators.

Critical data, processes are defined. Site Monitoring approach is proportionate to the risks inherent in the trial and importance of the information collected, adheres to the trial quality and risk management plan and incorporates patient and site centricity.

Timely performance of trial specific trainings to CT Managers and CRAs as per Trial Training Plan.

Site Monitoring plan, including oversight plan, available prior to the first Site Initiation Visit in a trial.

Regular communication maintained with trial team, internal and external partners as reflected in Trial Communication Plan.

Clear communication and direction for Site Monitoring activities provided regularly to CT

Managers/CRAs.

・Trial Conduct:

Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans.

Including but not limited to:

• Issue management / oversight on trial level.

• Pre-identification of important protocol deviations from site issues/deviations

• Continuous review, risk identification, evaluation/ analysis and communication on a trial level as applicable.

• Maintain Risk-based Site Monitoring approach for the trial and update Site Monitoring plan and trial level documents.

• Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) according to plan, implement follow-up actions and escalation, as required.

• Contribute to preparation and implementation of amendments to the trial level documents including training material updates/retraining as needed.

• Facilitate communication and training related to site monitoring in the trial:

Communication with CT Managers, CRAs, perform re- training etc.

• Participate, prepare input and (co-)lead Trial Oversight Meetings (country and trial level) and contribute to the timely responses to questions from external and internal stakeholders (including Regulatory Authority/ Ethics Committee).

Related performance indicators

Delivery of clinical trial according to defined milestones and Med-Ex key performance indicators.

Timely review, decision making, consultation, escalation, actions and follow-up of Site Monitoring/site quality issues.

Information that is essential to decision making (covering areas of responsibility) is collected, interpreted and timely communicated to the trial team including follow-up of assigned actions.

Timely update of the Site Monitoring & Oversight Plans and other core documents according to the protocol and quality and risk management plan.

・Trial Close-out:

• Coordinate timely cleaning and delivery of clinical trial data with Trial Team and countries

• Support compilation and review of the quality section for the clinical trial report for site monitoring activities

Related performance indicators

Timelines achieved as per commitments and defined

Med-Ex KPI targets for Data Base Lock.

Site Monitoring approach, including summary of important deviations and remedial actions taken are described in Clinical Trial Report.

・As a SML-l (if already assigned for ongoing trials in the transition period):

• Provides oversight of site monitoring activities for Japan and works with CTM to ensure the　outsourced monitoring services meeting quality

• Ensure study site monitoring activities according to GCP, BI-SOP/WI, protocol and monitoring manual

• Ensure inspection readiness activities on study site level

As a CRA (if assigned):

• Performs site selection and site monitoring activities per BI SOPs, applicable international and Japanese regulations / guidelines and ensure protection of trial subject's safety, data integrity and inspection readiness.

• Ensure completion of required training to trial staffs and adequate documentation

• Escalate non-compliance and implement CAPA

complete the responsible tasks of CRA independently without any support from others. In addition to this, the person can instruct and/or advise appropriately for less experienced staff.

Related performance indicators

Site related study KPIs effective management of site issue Monitoring visit report compliance

・Management and Relationship Responsibilities:

Adhere to international, local and internal requirements in the planning, conduct and reporting of

clinical trials.

Support the development of company relationships with opinion leaders and set up good working relationship with investigational site staff, internal staff, Vendors.

Participate in working groups related to site monitoring.

As a member of CD&O Japan, participate and contribute to different initiatives within CD&O Japan to achieve its vision, and priorities

Related performance indicators

Conducts work in a professional manner as evidenced by feedback from internal and external stakeholders.

・Leadership Competencies

• Creates an environment that inspires, motivates, and empowers colleagues and promotes one common CD&O identity, contributing to acceleration of clinical development timelines and value creation for patients.

• Can act as an established Subject Matter Expert A (SME) in the “SME network” globally

• Can act as a mentor supervising developing Site Monitoring Lead(s)in other R/OPUs

• Participate in working groups related to site monitoring within the global functional team.

Related performance indicators

Proactive and problem solving behavior

Demonstration of clear, concise, and effective communication taking into account the cross-organizational aspects.

In the area of responsibility, delivery of operational aspects and CD&O Regions Target Operational Model aligned to HPBU Intent, One Medicine vision, and CD&O Vision and Missions.

Efficient teamwork, leadership, and operational delivery.

・Foster a learning culture in CD&O regions by encouraging continues learning, sharing best practices, learn from failures.

Embraces innovative technologies, as well as creates and maintains a culture that drives empowerment, smart risk taking and one common CD&O identity

Regulatory and / or Organisational Requirements

Ensures all tasks are carried out in accordance with respective applicable BI Standard Operating Procedures (SOPs), Business Practices, How to Guides and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BI values and focus on speed and patient value.

Job Complexity

High complexity due to multiple interdisciplinary interfaces between all R/OPUs and Corporate CD&O functions and the magnitude and specificity of clinical trial protocol related issue. The complexity of the function is driven by the strict regulatory and ethical requirements during clinical development and differences in the conduct of clinical trials across the regions.

Works within a complex Good Clinical Practice (GCP) and regulatory environment and on global clinical trials with multi-disciplinary, international teams and with various internal and external stakeholders including vendors and investigational sites.

Represents the company for the function at internal and external meetings, e.g. with investigational sites or regulatory agencies/inspectors. Failure can have impact on the reputation of BI with stakeholders and regulatory agencies. More than one assignment in parallel requires balancing conflicting priorities. Is involved in design and implementation of new innovative methods including digital innovations related to trial delivery as working group member.

Interfaces

Functional leadership role within a clinical trial with no direct report. Liaises and partners with multi-disciplinary, international teams and both internal (i.e. functions inside and outside of Medicine) and external stakeholders (including vendors, regulatory authorities/inspectors) in the context of clinical trials.

Job Expertise

Proven track-record of multiple years of site monitoring and management experience covering sufficient & significant experience and knowledge in all stages of clinical trials (i.e. site selection, initiation, conduct and close-out) in different therapeutic areas from early to late phases of clinical development.

In-depth knowledge of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP) and understanding of legal/regulatory environment as it pertains to major regulatory authorities and relevant directives/regulations.

Understanding of major regulations (US FDA, EMA and PMDA).

Cross geographical experience. Working in multi-cultural environment; strong understanding of corporate culture and cross-cultural dynamics.

Demonstrated competencies in Agility, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking.

Solid project management and internal/external communication skills.

Job Impact

BI sponsored trials conducted according to applicable regulations and SOPs/procedures to safeguard patient safety / well-being, and data integrity. Participation in clinical trial brings value to patient and site. Site monitoring oversight has a significant impact on the budget and regulatory assessment of a clinical trial.

Functionally responsible for the site monitoring approach, processes and oversight for global clinical trials to ensure timely delivery, trial participant’s safety and quality and data integrity for Proof of Clinical Principle (PoCP), for marketing authorizations and label enhancement.

Minimum Education/Degree Requirements

University or comparable degree in life sciences or related field OR several years of equivalent professional education may be acceptable if complemented by solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities

Required Capabilities (Skills, Experience, Competencies)

Language: Fluent in English (written and spoken)

Strong Communication Skills: Demonstrates Accountability Agility Intrapreneurship (AAI) approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness.

Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors.

Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently coordinating and overseeing teams. Demonstrates leadership behaviors of supporting, connecting and empowering teams, setting priorities.

Language: Fluent in English (written and spoken)

Strong Communication Skills: Demonstrates Accountability Agility Intrapreneurship (AAI) approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness.

Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors.

Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently coordinating and overseeing teams. Demonstrates leadership behaviors of supporting, connecting and empowering teams, setting priorities.

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.