Project Manager – Sponsor Dedicated, Inflammation

🕒 vor 1 Monat

🌲 North Carolina – Remote

infoinfo

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👷‍♀️ Projektmanager

🗣️🇺🇸🇬🇧 Englisch erforderlich

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Syneos Health

10.000+ Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Syneos Health ist eine führende, vollständig integrierte biopharmazeutische Lösungsorganisation, die darauf ausgelegt ist, den Erfolg ihrer Kunden zu beschleunigen. Sie übersetzen einzigartige klinische, medizinische und kommerzielle Erkenntnisse in Ergebnisse, um den Anforderungen des modernen Marktes gerecht zu werden. Durch die Nutzung fortschrittlicher Technologien und Erkenntnisse arbeitet Syneos Health mit Kunden zusammen, um die Bereitstellung wichtiger Therapien für Patienten weltweit zu beschleunigen, und bietet Dienstleistungen, die das gesamte Spektrum von der klinischen Entwicklung bis zur Kommerzialisierung abdecken.

Beschreibung

• Provide guidance and daily oversight for successful management of all aspects of international clinical trials within designated budgets and timelines • Communicate with functional peers regarding project status and issues and ensure project team goals are met • Oversee operational aspects and conduct of assigned clinical trials, including study start-up, enrollment, maintenance, and close-out • Prepare and/or contribute to study-related documents, including clinical protocols, informed consent forms, pharmacy manuals, monitoring plans, CRFs, CRF completion guidelines, study plans, and clinical study reports • Coordinate data review supporting interim/final data analysis • Participate in study strategy development • Maintain study timelines • Contribute to study budget development • Contribute to RFP development and participate in CRO/vendor selection • Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements • Manage CRO interactions and sponsor oversight of operational functional activities • Proactively identify study issues/risks and recommend or implement solutions • Organize and manage internal team, investigator, and other trial-specific meetings • Participate in recruiting and hiring CPA/CTMAs and support their professional development • Coach work-team members and ensure adherence to established guidelines

🎯 Anforderungen

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology • Extensive Study Start-up Experience • Global clinical trial experience • Prior involvement in Inflammation studies • Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management • Highly developed leadership skills to successfully lead a clinical study team • Ability to deal with time demands, incomplete information or unexpected events • Must display strong analytical and problem solving skills • Attention to detail • Outstanding organizational skills with the ability to multi-task and prioritize • Excellent interpersonal, verbal and written communication skills are essential • Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities • Equivalent experience, skills, and/or education will also be considered

🏖️ Vorteile

• career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition and total rewards program • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • flexible paid time off (PTO) and sick time • company car or car allowance may be included

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