Clinical Research Manager
vor 4 Wochen
The Clinical Functional Service Partnerships (Clinical FSP) department at IQVIA is seeking a highly skilled Local Trial Manager to support our client's project team in the execution of clinical trials. As a key member of the team, you will have the opportunity to work with a single client and manage clinical research projects in various therapeutic areas.
Responsibilities:- Ensure compliance with company standard operating procedures (SOPs), work instructions, policies, Good Clinical Practice (GCP), and local regulatory requirements.
- Prepare or contribute to high-level budget estimates and detailed budget proposals, ensuring overall contract management, including review and approval of external service provider (ESP) contracts and change orders.
- Act as the primary company contact for assigned trials at the country level, ensuring local/country teams track project progress against planned timelines and monitor patient recruitment rates to meet target enrollment.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports to analyze trial progress, and participating in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
- Contribute to site-level recruitment strategies and contingency planning, implementing solutions in partnership with other functional areas to achieve clinical research targets.
- Deliver competent vendor management at the country level, supporting the study and submitting requests for vendor services and supporting vendor selection.
- Contribute to patient understanding of protocol and patient safety by reviewing country-specific informed consent in accordance with procedural documents/templates.
- Ensure trial subject safety by reporting all Adverse Events (AEs), Serious Adverse Events (SAEs), and Protocol Violations (PQCs) within required reporting timelines and documenting them 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 and archiving retention requirements where applicable.
- Work closely with the Global Trial Lead (GTL) and Clinical Project Lead (CPL) to implement Corrective Action Preventive Action (CAPA) for audits/inspections or quality-related issues/concerns.
- Ensure accurate finance reporting and trial delivery within budget by adhering to finance reporting deliverables and timelines, including forecasting and proactive management of country/local trial budgets.
- Organize and ensure IEC/HA approvals, if applicable, to maintain trial compliance with local regulatory requirements.
- May contribute as a mentor, champion, or representative of the functional area in process initiatives, as required and if applicable.
- Bachelor's or higher-level degree in a life science field.
- Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO, plus preferable 2-3 years of clinical trial management experience.
- Strong working knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Fluent language skills in German on at least C1 level and good command of English, with proficiency in speaking and writing in both languages.
- Strong IT skills in appropriate software and company systems, with willingness to travel occasionally with overnight stays away from home according to business needs.
- Excellent decision-making and strong financial management skills.
- Flexibility and ability to manage study teams in a virtual environment.
- Flexibility to business travel (client meetings and occasional site visits).
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