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Associate Regulatory & Start-Up Manager (Qcare) (Based in Raleigh-Durham, NC) - (1804020) in United States at IQVIA™

Date Posted: 2/13/2018

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description

PURPOSE 

Manage the delivery of all required start-up, maintenance and regulatory activities for sites in the Qcare network.  Develop strong understanding of processes and associated costs at assigned sites.  Proven experience creating budgets, negotiating contracts, and managing regulatory documents for a site(s) is preferred.  Any experience with Medicare Coverage Analysis desired but not required.  Primary focus will be budget creation for Qcare sites clinical studies.

RESPONSIBILITIES



  • Oversee the execution of Start Up () and/or Maintenance for assigned sites. Develop, implement and maintain the start up activities (regulatory documents, budget creation, contract negotiation) according to the needs of the site and the study. Primary focus will be budget creation. Develop study budgets based on the needs of the study and the site.  Ensure medicare coverage analysis is conducted when required through internal or external vendor. 
  • Ensure collaboration with internal RSU colleagues, including communication with regions and countries, to successfully deliver the agreed project scope.
  • Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
  • Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional projects during initial start-up and maintenance phase as an integral member of the Qcare team.
  • Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies, as required.
  • Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics as required.
  • Work according to Quality plan to ensure appropriate quality standards for the duration Start Up (or Maintenance, as applicable).
  • Mentor colleagues as required.
  • Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
  • May take a proactive role in developing long standing relationships with preferred IQVIA customers.
  • Deliver presentations/training to clients, colleagues and professional bodies, as required 


Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Good negation and communication skills with ability to challenge
  • Good interpersonal skills and strong team player;
  • Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
  • Demonstrated proficiency in using systems and technology to achieve work objectives
  • Thorough understanding of regulated clinical trial environment and knowledge of drug development process
  • Good regulatory and/or technical writing skills
  • Good knowledge and ability to apply GCP/ICH and applicable regulatory guidelines Good leadership skills, with ability to motivate, coach and mentor
  • Good organizational and planning skills
  • Proven ability to exercise independent judgment taking calculated risks when making decisions
  • Good presentation skills
  • Good understanding of site and study financial management
  • Ability to establish and maintain effective working relationships with co-workers, managers and sponsors
  • Proven ability to work on multiple projects balancing competing priorities


MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor's degree in life sciences or related field, with 5 years’ relevant experience in a scientific or clinical environment including demonstrable experience in acting as the main start-up lead in studies or equivalent combination of education, training and experience


PHYSICAL REQUIREMENTS
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • Occasional travel may be required


EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.


Whatever your career goals, we are here to ensure you get there!


We invite you to join IQVIA™.


Job ID: 1804020