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*Senior CRA and Local Trial Manager (f/m) - combined role, based in Denmark* - (1803903) in Denmark at IQVIA™

Date Posted: 2/12/2018

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.
 
This is the opportunity to join IQVIA™ in a combined position as Senior CRA and LTM (f/m), who would like to take over responsibilities within our GFR department in Denmark.
 
 
PURPOSE
Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
 
RESPONSIBILITIES
 
As a SrCRA:
 
  • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
  • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Act as a mentor for clinical staff including conducting co-monitoring and training visits.
  • May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes.
 
 
As a LTM:
  • Performs the role of Local Trial Manager (LTM) including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.
  • LTM is a person within Trial Co-ordination and Site Management responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries.
  • The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements.
  • LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants, Site Managers and LTMs. The LTM may have some site management responsibilities. An LTM I usually performs principal responsibilities under the direct supervision of an LTM II or III and/or Functional Manager.


Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • In depth therapeutic and protocol knowledge as provided in company training
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
  • Strong written and verbal communication skills including good command of English and Danish language
  • Excellent organizational and problem-solving skills
  • Effective time management skills
  • Ability to manage competing priorities
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor's degree in a health care or other scientific discipline or educational equivalent and a minimum of 3 years of on-site monitoring experience; or equivalent combination of education, training and experience
 
IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.

Job ID: 1803903