Experienced Clinical Research Associate - Sponsor dedicated - Istanbul

Contenido de trabajo

IQVIA clinical FSP business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our clients. We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study.

Leadership recognizes the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows. Our managers understand the sponsors priorities and the individual aspects of each model. Focus is given to career development from day one, including new hire orientation and onboarding, day to day problem solving and training and development.

Unique to the FSP model, our team contributes to the pipelines of the specific sponsor and therefore our CRAs are ‘indication and molecule experts’.
Responsibilities

• The role holder may be required to cover all responsibilities mentioned below but will be expected to focus on certain responsibilities for periods of time.
• Accountable for the oversight and execution of Start Up (from pre-award/bid defense activities up to Maintenance and Investigational Product (IP) release for all assigned projects in accordance with the agreed RSU strategy.
• Responsible for the development, maintenance and implementation of the RSU plan according to the Scope of Work and Project Plan within the agreed strategy, escalating issues where required.
• Ensure cross collaboration across RSU and communication with regions and countries to successfully implement the agreed RSU plan.
• Provide overall guidance and oversight of multi-site projects during maintenance phase as an integral member of the study management team.
• Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
• Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan.
• Create, publish and review core scientific, technical and administrative documentation necessary for enabling study initiation and maintenance.
• Assess and review regulatory landscape and contribute to collection, interpretation, analysis and dissemination of accurate regulatory intelligence.
• Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. Work with Quality Management to ensure appropriate quality standards for the duration of the start up.
• Mentor and coach colleagues as required and provide technical guidance both within and outside the project.
• Ensure accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role.
• May take a proactive role in developing long standing relationships with preferred IQVIA customers.
  
  

Required Knowledge, Skills And Abilities

• Good negotiating and communication skills with ability to challenge
• Excellent interpersonal skills and strong team player; ability to co-ordinate and collaborate above, across and within complex projects.
• Good regulatory and/or technical writing skills
• Good understanding of regulated clinical trial environment and in depth knowledge of drug development process
• Ability to exercise independent judgment taking calculated risks when making decisions
• Good leadership skills, with ability to motivate, coach and mentor
• Good organizational and planning skills
• Good presentation skills
• Understanding of study financial management
• Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
  
  

Minimum Required Education And Experience

• Bachelor’s degree in life sciences or equivalent combination of education, training and experience,
• min.6 years’ of relevant experience in clinical research including at least 2 years’ of demonstrable experience in an global role,
• Good negotiating and communication skills with ability to challenge.
  
  

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.