Senior Clinical Trial Manager

Basic purpose of the job

The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the Japan level.

CTMs contribute to delivery of BI's pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites.

The CTM provides leadership and direction to the trial team in Japan and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators (e.g. Medicine Excellence KPIs -MedEx). They are responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders (e.g. investigative sites) and trial team members at a Japan and global level.

The CTM is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation.

The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader ("CTL") on all study-related issues.

As leader of the Trial Team in Japan, the CTM communicates trial status to stakeholders, escalating issues as appropriate.

Senior CTM's Job Grade is G5 : Be an expert in clinical operation who leads Clinical Operation Excellence and guides and mentors junior CTMs and trial team members in Japan to facilitate their growth as a team to achieve operational excellence ; Acts as a delegate of Head of Experimental Medicine Clinical Operation Japan ; Co-leads non-trial work with Head of Experimental Medicine Clinical Operation Japan.

Accountabilities

Trial Preparation

Accountable for the trial activities for Japan, including but not limited to:

Ensure the trial is conducted in compliance with ICH-GCP, local/global regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities
Creation, management and review of the Japan trial budget to ensure appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes
Appropriate trial-specific training of Japan internal and external partners is performed in line with Trial Training Plan
Accurate planning and co-ordination of operational feasibility of trial timelines for Japan; and oversight of trial preparation to ensure trial team members are aligned and on track
Verifies and provides input into the country and site level feasibility and commitment in Japan (site and patient commitment). Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions (i.e. Medical Affairs, vendors if applicable)
Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value
Frontloading of activities where possible at Japan level to facilitate efficiencies as well as to ensure and leverage speed.
Oversees outsourcing of vendor services in Japan in accordance to operating models and governance
Ensure timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders

Trial Conduct

Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.

In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, and safety reporting
Monitor progress of patient recruitment endpoints and proactively update and action contingencies throughout trial conduct.
Support CTL during investigator meetings, if required
Establish and maintain relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst Exp Med, CD&O and appropriate functions (i.e Medical Affairs, Market Access, PAR) on Japan level
Active participation in the Exp Med community with a special focus on participating in the CTM network, to actively contribute to functional excellence

Trial Closeout and Reporting

Ensures timely cleaning and delivery of clinical trial data
Responsible for timely, complete and compliant archiving of all relevant Japan level documents in the TMF, including all required documents from vendors
Ensures timely submission of the CTR to Regulatory Authority/Ethics Committee and other external stakeholders as required by local regulations
Shares information on trial results with Investigational sites and, if applicable, Patients (e.g. lay summaries)

General accountabilities

Build and maintain engagement with Investigators, other site staff and Patient Organizations (POs), in collaboration with other functions, to ensure trial speed and effective start up, conduct and close out
Establish and maintain relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst Exp Med, CD&O and appropriate functions (i.e Medical Affairs, Market Access, PAR) on Japan level
Supports CTL to ensure issues are raised to Evidence team for timely action or mitigation

Supports regional CDP input from Japan where CTM is assigned as a Exp Med Japan representative in Japan clinical development team (JCDT).

Works with related working groups, Exp Med, CD&O Japan management team and actively contributes and supports early input to CDP and/or Trial Design Outline (TDO), if applicable, from Exp Med Japan perspective
Aligns with relevant medicine functions in Japan to ensure proper communication on CDP-related topics from Exp Med and CD&O aspects, including but not limited to, Japan integration strategy, trial design/timeline/budget for Japan, engagement of potential investigators in Japan
Leads/overseas initiatives within Exp Med; Participates in the Medicine-wide/cross-function initiatives to achieve Medicine Excellence; Represents Exp Med in the industry association activities
Act as a delegate of Country Trial Management Lead to support oversight of CTM activities, to resolve complex issues that impact the quality, timeline and cost of trial management deliverables and to share lessons learned to continuously improve performance of Exp Med Japan delivery

Leadership Competencies

Creates an environment that inspires, motivates, and empowers colleagues and promotes one common Exp Med identity, contributing to acceleration of clinical development timelines and value creation for patient
Fosters a learning culture in Exp Med Japan by encouraging continuous learning, sharing best practices, and learning from failures
Embraces innovative approaches and technologies, as well as creates and maintains a culture that drives empowerment, smart risk taking and one common Exp Med identity

G5:
Co-leads with Head of Experimental Medicine Clinical Operation Japan , promotes, role model and embeds the culture of empowerment within Exp Med Japan to achieve Exp Med Goal

Regulatory And / Or Organisational Requirements

Ensures all tasks are carried out in accordance with respective applicable BI SOPs, BI Business Practices, HTGs 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, in accordance with BI Values and a focus on speed and patient value.

Job Complexity

Functionally leads trial team in Japan to ensure integrity of trial conduct, assurance of patient safety, and that Japan component of trial is planned, conducted and reported in line with regulatory requirements.

Requires orchestration of trial team in Japan, setting priorities, and integration with other functions as necessary throughout planning, conduct and closeout of trial.

This requires co-ordination of/with diverse and international trial team members, and collaboration with other external stakeholders.

The complexity of the role is driven by the strict regulatory and ethical requirements.

Works on global clinical trials with multidisciplinary, international teams and with internal and external stakeholders including suppliers and investigational sites.

Represents the company at internal and external meetings, e.g. with investigational sites, patient organizations and/or regulatory agencies/inspectors.

Critical contribution to speed and value of our clinical trials by providing input in strategic feasibility, maintaining relationship with sites and by implementing new innovative methods including digital innovations related to trial delivery.

G5:
Increased job complexity depending on the tasks and/or roles delegated by Country Trial Management Lead.

Interfaces

Functional lead and/or project manager of trial team members in Japan and colleagues including but not limited to:

Exp Med
CD&O
Other medical functions
HP functions in Japan (including patient advocacy)
CRO and other suppliers
Investigator and site staff
Research networks
Patient organizations (PO)

Job Expertise

Strong clinical trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-performance teams
Experience in Therapeutic Areas relevant in BI pipeline is desirable
Understanding of major regulations in Japan
Familiarity with guidelines and standard of care is desirable
Experienced in working with CROs and POs is desirable
Ability to build and maintain strong relationships of mutual value
Excellent influencing and communication skills

Job Impact

Accelerates the delivery of innovative new therapies while bringing the best trial experience to sites and patients;
Clinical development of a substance occurs within Medicine Excellence KPIs, quality and budget given by IU and HPBU;
BI sponsored trials conducted according to applicable regulations and BI SOPs/procedures safeguard patient safety / well-being, and data quality and integrity;
Risk management at Japan level allowing development of a substance in line with BI strategy
Strong accountability to support trial oversight in Japan

Minimum Education/Degree Requirements

Degree /education:
university degree (e.g. Masters degree or comparable degree) with several years relevant experience in required area.


Major focus:
Biomedical Life Sciences is desirable.

Required Capabilities (Skills, Experience, Competencies)

Strong Communication Skills:
Demonstrates 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 aspects of 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 setting direction for teams.

Demonstrates leadership behaviours of supporting, connecting and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to achieve a common goal.

Executes activities with a clear aim to deliver value to patients

Strategic Mindset:
Strategic and visionary thinker who is future focused, creative, courageous and able to navigate through ambiguity. Integrates study strategy with overall TA portfolio. Embraces cross functional initiatives, applying innovative learnings. Is results-oriented with a global mindset using analytical thinking to provide risk-balanced solutions

Coordination and Oversight:
Collaborative leader who demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources

Project Management:
Plans effectively, setting priorities, and defining actions. Makes effective use of resources, and proactively strives for transparency and clarity to accomplish the business deliverables. Translates complex situations to actionable parts. Anticipates and resolves challenges and translates learnings to new projects. Takes smart risks

G5:
be able to manage highly complex tasks including large-scale, high priority trials and initiatives to innovate clinical trials; organization skills and capabilities that enable to manage several clinical trials in parallel
Required English speaking CEFR level : B2

Our Company

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority.

Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare.

By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-
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