IQVIA
IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we are in is cutting edge for therapies with un-met medical need.
IQVIA Biotech has an exciting position within its EU Clinical Monitoring team. The Clinical Monitoring department is the largest team within IQVIA Biotech, providing CRA, Clinical Leads, Management and oversight to global clinical studies.
Please note, for this role you must be based in the Netherlands.
Basic Functions:
Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.
Responsibilities
Participates in the investigator recruitment process, performing site evaluation visits of potential investigators to evaluate the capability of the site to successfully manage and conduct the clinical study.
Coordinate activities with the site and internal departments in preparation for the initiation of the study. Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF and EDC system; monitoring activities and study close-out activities.
Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs.
Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory.
Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification and works with sites to resolve data queries and produce robust data.
May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
Assists with, and attends, Investigator Meetings for assigned studies.
Attends study-related, company, departmental, and external meetings, as required.
Ensures all study deliverables are completed per IQVIA Biotech and study timelines
Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
Serves as mentor for junior CRAs and those new to the company and/or study.
KNOWLEDGE, SKILLS AND ABILITIES:
Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
Minimum of 1-2 years of onsite monitoring experience is a must.
Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
Able to handle several priorities within multiple, complex trials.
Able to reason independently and recommend specific solutions in clinical settings.
Able to work independently, prioritize, and work within a matrix team environment.
Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
Candidates must have strong communication levels of Dutch and English.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.