03 ott
|
Alira Health
|
Verona
03 ott
Alira Health
Verona
h3Job Description Summary Job Description /h3pAre you being referred to one of our roles by a connection in Alira Health? Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. /ph3ROLE /h3pThe Project Manager (PM) is an important member of the Alira Health Clinical team. The PM ensures the efficient implementation of one or more study protocols, works closely with all Clinical team members, and communicates directly with study sponsors and vendors. Salary range: € 50k - € 70k /ph3KEY RESPONSIBILITIES /h3ulliManages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines. /liliServes as study lead and primary contact for sponsors. /liliManages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory. /liliGenerates and presents frequent study status updates and reports to sponsor. /liliSupervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates. /liliSupervises and trains Associate PMs. /liliCreates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc. /liliDrives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones. /liliEnsures accuracy of reports and material work product.
/liliProvides monthly billing information to finance team. /liliPresents at project meetings such as investigator meetings and new client meetings. /liliUpdates management accurately and regularly through frequent communication. /liliIdentifies issues and develops problem-solving strategies to ensure study timelines are met. /liliManages subject accrual, retention, and compliance. /liliAssists in TMF management and manages TMF reviews as needed. /liliPrepares for and participates in third-party audits and FDA inspections. /liliComplies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs. /liliParticipates in internal, client/sponsor, scientific, and other meetings as required. /liliPerforms additional duties as assigned. /li /ulh3DESIRED QUALIFICATION EXPERIENCE /h3ulliBS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience. /lili3 years of experience in the pharmaceutical / biotechnology / CRO industry with 1 year of management experience. /li /ulh3TECHNICAL COMPETENCES SOFT SKILLS /h3ulliProven ability to be careful, thorough, and detail-oriented. /liliStrong organizational skills and the ability to multi-task and work effectively in a fast-paced environment. /liliStrong analytical, negotiation, meeting management, cross-functional team, and leadership skills. /liliSelf-starter who thrives in a collaborative, yet less structured team environment.
/liliAbility to problem-solve unstructured or ambiguous challenges. /liliStrong command of English, both written and verbal. /liliExcellent communication and interpersonal skills with customer service orientation. /liliProficient with MS Office Suite, particularly Word and Excel. /li /ulh3Languages /h3pEnglish /ph3Education /h3ulliBachelor of Science (BS): Biology, /liliBachelor of Science (BS): Life Sciences, /liliBachelor of Science (BS): Pharmacy /li /ulh3Contract Type Regular /h3pSalary Range The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope. /ppAlira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle. With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork. We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience. /ppLearn more /p #J-18808-Ljbffr
📌 Project Manager (Verona)
🏢 Alira Health
📍 Verona