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R and D Senior Local Trial Manager - Belgium   This individual will be responsible for leading one or several clinical trials within the Clinical R&D Operations CoE, as well

BrightOwl (company)


Functional titles : Clinical Trial Manager (CTM) ,  Clinical Project Manager (CPM) ,  Clinical Project Leader ,  Senior Clinical Project Manager (CPM)
FTE : 100 %
Min.Experience : Senior
Start Date : 01 Jun 2017
End Date : 01 Jun 2018
Posted on : 23 May 2017

Project is currently here

Step 1
Application
Step 2
BrightOwl Screening
Step 3
BrightOwl Interview
Step 4
Company Screening
Step 5
Company Interview
Step 6
Budgets & Contracts
Step 7
Position filled

Project Description

  • Serve 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
  • Manage 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
  • 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 clinical trials/programs 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
  • Requires 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
  • Demonstrated competencies in the following areas are required:
  • Behave and lead in a professional and ethical manner
  • Presentation skills and influencing of others
  • Advanced technical writing skills
  • Advanced 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.

Others

Project FTE 100%
Work from home:   Not Allowed
No. of Positions:   1

Personality

Communicative Collaboration Problem solving Responsibility

Knowledge

R&D Clinical trial budgeting Clinical trial management Clinical Trial Management System (CTMS) Clinical Data Management (CDM) Clinical trials Communication Skills Good Clinical Practice (GCP) management

Skills and Expertise

Write papers Collaborate with project team Coordinate projects Interact with CROs Manage Clinical Trial Management System (CTMS) R&D Solve problems Write clinical evaluation reports Write documents Write medical reports

Degree

Bachelor Master Ph.D.

Field of study

Pharmaceutical Sciences (Optional)

Languages

English
Full Proficiency
Mandatory
Dutch
Elementary Proficiency
Good to have

Desired Skills & Experience

People Leadership:

  • 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. 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 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. Experience
  • 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, a plus.
  • Clinical/medical background a plus.
  • Medical device experience a plus.

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