Clinical Trial Leader

Location: Belgium

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Medical Devices organisation, based in Brussels Hoofdstedelijk Gewest Belgium.

The Company

The company is a multinational healthcare leader with a diversified portfolio of prescription medicines, vaccines, innovative medicines and medical devices.

Role Description

The Clinical Trial Leader will be responsible for clinical trial management within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization. The CTL is a member of the clinical trial/study/program core team and serves as the (back-up) liaison to the Clinical R&D Franchises in Medical Devices and Clinical R&D Biostats and Data Management (BSDM) for projects/trials/programs under his/her responsibility.

Responsibilities

Clinical Trial Management:
- Manage all operational activities of assigned clinical trials/programs within the Clinical R&D Operations group and serve as the primary contact for clinical trial sites
- Independently solve problems arising during clinical trial execution (seek guidance for more complex problems if necessary)
- Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
- Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
- Plan, track and manage assigned projects budgets to ensure adherence to business plans
- Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
- Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
- Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
- Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency

People Leadership:
- Provide primary leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus.
- Ensure efficient use of resources within the clinical trial/program to provide high quality deliverables.
- Manage and mentor Clinical Trial Leaders/Sr. Clinical Trial Leaders/Staff Clinical Trial Leaders, as applicable.

Business Leadership:
- Accountable for quality, compliance with regulations and company procedures, resource requirement, timelines and budgets for assigned clinical projects, including those assigned to direct reports.
- May lead clinical trials and/or a program that may involve multiple trial managers/leaders and CROs (500k USD annual investment).
- Act as an operational expert rotating to new projects to provide technical expertise and training in starting new studies.
- May support Senior CTM within a large or complex regulated clinical trial/program.
- Exhibit proficiency and act as a Subject Matter Expert in clinical trials involving complex design issues. May provide solutions and guidance on complex situations.
- May manage work performed by CROs.
- Identify and ensure that strategies, resources, and accountabilities are in place to achieve rapid, cost-effective, and high quality execution of assigned clinical studies/programs, including those assigned to direct reports.
- May support clinical trial design and strategy.
- Reviews and provides feedback on protocols.
- Understand business value and balance overall business objectives and functional needs.

Requirements

Education and Experience requirements:
- Masters or equivalent required in Life Science, Nursing or Biological Science
- 8 -10 years of significant & relevant experience in clinical project leadership across multiple studies/programs required
- Minimum of 2 years' experience in people management.
- Experience with budget planning, tracking and control required.

Functional and Technical Competencies:
- Requires knowledge of Good Clinical Practices
- Knowledge and application of regulations and standards applied in clinical areas/regions is required.
- Strong project management skills with ability to handle multiple projects
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Alexander Wielemaker.