Interested to start your career as a Consultant at XPE Pharma & Science or you're Freelance and available full time until December 2019? We are looking for a LOCAL TRIAL MANAGER!
YOUR DUTIES & RESPONSIBILITIES:
• Serve as a Clinical Trials Leader within the Clinical 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 Operations group
• Serves as a member of the clinical trial/study core team and may serve as the liaison with the Clinical Franchise and Clinical Biostats & Data Management (BSDM) for projects under his/her responsibility
• May serve as the primary contact for clinical trial sites
• Solves problems with support from Clinical Management 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 Operations and Clinical Franchise as needed
• Track 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
• Provide 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 deliverable.
AND also: Business Leadership Responsibilities:
• Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials.
• May support and/or lead several small/medium clinical trials (regulated and non-regulated) and/or a small number of large non-regulated projects that may involve other clinical operations staff
• May assist with the management of large regulated or complex trials/program under supervision of CTM or Senior CTM.
• Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical trials under his/her responsibilities.
• Reviews and provides feedback on clinical operation section of protocols with supervision.
Functional and Technical Competencies:
• Requires understanding of Good Clinical Practices
• Understanding and application of regulations and standards applied in clinical areas/regions is required.
• Good presentation skills and effectively influencing of others
• Written and oral communication skills
• Demonstrated competencies in the following areas are required:
• Behaving in a professional and ethical manner
• Leadership skills
• Technical writing skills
Leadership required in alignment with Imperatives:
• Connect - Develop collaborative relationships with key internal and external stakeholders, principally within allocated study teams and department as well as the resources providers and vendors to create a strong and productive partnership
• Shape - Actively participate in departmental process improvement activities.
• Lead - Take ownership for development of self and engage in transparent and constructive conversations.
• Deliver - Strive to ensure all deliverable on allocated studies are met on time, within budget and in compliance to SOPs and regulations.
• Minimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, or Biological Science.
• 2-4 years of relevant experience required.
• Previous experience in clinical trial management or equivalent is required.
• Clinical/medical background a plus.
• Medical device experience a plus.
Why work as a consultant for XPE Pharma & Science?
XPE is a part of Adecco, one of the Top 5 companies within the 'Great Place to Work' ranking
At XPE Pharma & Science you're not just a consultant, you are one of a kind.
Our HR Talent Managers value Talent and build client-focused solutions with that in mind. They are dedicated to help you boost your career. This by coaching sessions, development centers and performance reviews.
Respect and professionalism are at the basis of our job. We are willing to go the extra mile for and with you.
This job is made for you? Don't delay and apply by sending me your CV and cover letter in word: email@example.com
You are not ready to apply or have questions? Don't hesitate to contact me and we will discuss in total confidence:
Thank you. Carine