Local Trial Manager - Senior

Région
Beerse
Publication
jeudi 18 mai 2017
Date limite
dimanche 18 juin 2017
Réf
6D09EXPE-BE
Contact
Andreea Ardelean
Fonction
Autre
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Local Trial Manager - Senior Organisation description:

XPE Pharma & Science is looking for a Local Trial Manager, for one of its clients, a well-known company in the pharmaceutical industry. This individual will be responsible for leading one or several clinical trials within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization. In addition, he/she serves as the trial leader for clinical study execution. 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.

Job 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 deliverable while maintaining optimal efficiency. Functional and Technical Competencies:  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. 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.

Profile:

 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.

Offer:

Open end contract on XPE payroll; Highly professional working environment.



Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713