The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with one single client and to manage clinical research projects in different therapeutic areas.
We currently offer the exciting opportunity to join the team as Local Trial Manager (m/w/d) in full-time and work home-based throughout Germany.
Your responsibilities will include:
- Services rendered will adhere to applicable company’s standard operating procedures (SOPs), work instructions, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
- Prepare or contribute to high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensure overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensure services are delivered per contract.
- Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
- Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection.
- Contribute to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates.
- Ensure trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.
- Ensure Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
- With focus on quality, work closely with Global Trial Lead, Clinical Project Lead to ensure CAPA is implemented for audits/inspections or any quality related issues or concerns.
- Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.
- Keep the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
- May contribute as a mentor, champion, or representative of functional area in process initiatives, as required and if applicable.
Qualifications:
- Master’s or higher-level degree in life science.
- Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO plus 1-3 years of local clinical trial management experience.
- Therapeutic area expertise in the field of Oncology is a must.
- Strong working knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Fluent languages skills in German on at least C1 level and good command of English.
- Strong IT skills in appropriate software and company systems.
- Excellent decision-making and string financial management skills.
- Flexibility and ability to manage study teams in a virtual environment.
- Willingness to travel occasionally for business meetings.
We invite you to join IQVIA.
Why join us?
Ongoing development is vital to us enabling you to have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set.
Our benefits package is competitive, our scope is international, and we genuinely care about our people and their success.
Whatever your career goals, we are here to ensure you get there!
Please apply with your English CV, motivation letter and your certificates and reference letters.
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.