Lead Clinical Project Associate (m/f/d)
Frankfurt am Main
Our leading position in the global market in the areas of Aesthetics, Therapeutics, and Consumer Care is the result of our innovative spirit and the commitment of our staff. Our highly attractive portfolio, a strong strategic focus, and dynamic characterize us as a company that is heading towards long-term growth and success. Do you share our enthusiasm for customer oriented work and are willing to take up the task of continuing to write our success story? Then join Merz Aesthetics as Lead Clinical Project Associate (m/f/d) Clinical Projects Aesthetics You support the operational conduct of clinical trials in the area of aesthetic medicine by supporting with the selection, qualification and training of external providers and clinical trial sites, submission to regulatory authorities and the Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provide investigational product and trial-specific material You are responsible for the preparation and review of clinical documents and support the preparation and review of trial-specific documents (Informed Consent Form (ICF), submission document to IEC/IRB and regulatory authorities, training documents, manuals, Monitoring Plan, Clinical Study Report (CSR) appendices, Clinical Study Protocol (CSP), Project Plan, Monitoring Plan, Data Management Plan) You maintain the Trial Master File (TMF)/eTMF and ensure the readiness for audit/inspection and prepare the TMF/eTMF for long-term archiving You coordinate internal and external operational tasks and team meetings You support the planning and controlling of the budget and payment of external providers and trial sites You support internal status reporting and maintain the trial database (METIS) You perform in-process control checks on an operational level (QC check of CSP, monitoring report, ICF, CSR) and co-monitoring visits You support audits and the management of CAPAs in collaboration with involved functions University degree in life sciences or medical health (Bachelor) or other professional qualifications equivalent to university degree At least 3 years of experience in coordinating and conducting clinical trials tasks Experience as a clinical research associate and experience in other areas in clinical research and respective processes Advanced knowledge in relevant regulations (ICH GCP, DIN EN ISO, EU CTR, MDR, FDA, etc.) and medical or scientific terminology Advanced verbal, written communication and presentation skills in German and English You are a team player, flexible and able to support various projects simultaneously Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point, Outlook) applications to prepare charts, tables, forms, reports, and presentations Your skills also include analytical thinking and a highly structured way of working Meaningful work and exciting projects from day one Collaboration in multi-functional and global teams Flexible work hours Attractive conditions and extensive social benefits Personal & professional development An open & international work environment in a global family-owned business Participation in the company programme "We care for your beauty"