Senior Local Trial Manager
- Contract Type
SENIOR LOCAL TRIAL MANAGER
Location: Diegem, Belgium
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a SENIOR LOCAL TRIAL MANAGER for one of our clients, a medical devices company, that is part of a TOP pharmaceutical company in Belgium.
The candidate will serve as a trial leader for clinical study execution and will be responsible for leading one or several clinical trials within the Clinical R&D Operations, as well as fostering strong, productive relationships with colleagues across the organization. This is a very exciting and challenging position, where you will have the opportunity to be engaged with process improvement, but will also have the flexibility to organise your work individually. The position also demands some travelling.
- Serves as a Clinical Trials Leader within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device Franchises
- Manages all operational activities of assigned clinical studies within the Clinical R&D Operations group
- Serves as a member of the clinical trial/study/program core team and may serve as the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under his/her responsibility
- May serve as the primary contact for clinical trial sites
- Independently solves problems arising during clinical study execution, and will seek guidance for more complex problems, as needed
- Provides 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
- Plans, tracks, and manages assigned clinical trials/programs budgets to ensure adherence to business plans
- Supports the implementation of new clinical systems/processes, and provide support for publications, as needed.
- Interfaces and collaborates with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
- Ensures personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
- Manages resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
- Knowledge of Good Clinical Practices
- Knowledge and understanding of application of regulations and standards applied in clinical areas/regions
- Effective leadership skills in a professional and ethical manner
- Strong written and oral communication skills
- Presentation skills and influencing of others
- Advanced technical writing skills
- Advanced project management skills with ability to handle multiple projects
- Knowledge of all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
- Provide strong 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 study/program to provide high quality deliverables
- Manage and mentor Clinical Trial Leaders/Senior Clinical Trial Leaders, as applicable
- 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 studies and/or programs that may involve multiple study managers/leaders and CROs
- Act as an operational expert rotating to new projects to provide technical expertise and training in starting new studies
- May support Senior CTM or CTM within a large or complex regulated clinical study/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 done by CROs under CTM/Senior CTM guidance
- Identify and ensure 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
- Independent decisions for most situations, but may require guidance for to complex situations. Minimal supervision needed
- Reviews and provides feedback on clinical operation section of protocols with minimal supervision
- Understand business value and balance overall business objectives and functional needs
EDUCATION & EXPERIENCE REQUIREMENTS
- Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
- BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred
- Previous experience in clinical trial management or equivalent is required
- Experience working well with cross-functional teams is required
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)
- Experience managing others, clinical/medical experience and medical device experience are considered a plus
If you have any questions please contact Vanessa Verdickt, Consultant TalentSource Life Sciences, or apply directly at https://www.talentsourcelifesciences.com/find-a-job/
Our benefits when working via TalentSource Life Sciences
- Dedicated local Line Manager - 1-2-1 support
- Face to face coaching meetings/Monthly Calls - we care for your wellbeing
- Employee satisfaction survey - your feedback is important for continuous improvement
- End year appraisals and development planning
- Ability to attend our annual team event and local New Year's diner
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services.
TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them.
With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Medical Devices, Clinical Project Manager, Clinical Trial Manager