Clinical Project Research Manager – EDS, RWE, NIS

🔥 il y a 23 heures

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

🗣️🇺🇸🇬🇧 Anglais requis

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UBC

1001 - 5000 employés

Fondée en 2003

🏥 Santé

💼 Conseil

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

UBC est une entreprise dédiée à l'amélioration des résultats pour les patients en reliant les thérapies spécialisées aux patients dans le besoin. Elle offre des solutions modernes et personnalisées axées sur l'accès, la sécurité, et la génération de preuves pour les produits biopharmaceutiques. UBC se spécialise dans le développement de preuves, la gestion des risques, et l'accès des patients, en utilisant des données du monde réel et des technologies innovantes pour optimiser le parcours de soins et assurer l'utilisation efficace des médicaments.

Description

• Plan, organize, and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope • Oversee all aspects of project conduct from start-up through close-out • Execute operational aspects of assigned project activities and special projects • Manage projects according to scope of work and contracted budget • Manage project revenue and invoicing • Ensure projects follow UBC and applicable client SOPs • Develop project plans and processes to achieve contracted milestones • Monitor project progress and compliance against established plans • Prepare project timelines and coordinate deliverables • Prepare meeting agendas, minutes, and action logs • Track project budgets against contract milestones • Serve as UBC’s primary sponsor contact • Coordinate project meetings with internal and external stakeholders • Resolve project team member questions • Supervise functional areas supporting projects • Lead cross-functional projects • Ensure and assist with project training • Develop and lead internal and external kick-off meetings • Negotiate budgets and assist with contract remediation • Present project information at bid defenses, client meetings, and monthly project reviews • Maintain audit-ready project documentation • Participate in sponsor/regulatory audits • Coordinate investigator meetings • Assist with protocol development and patient/subject consent forms or REMS documents as required • Lead process improvement activities • Establish, implement, and track key project metrics • Coordinate maintenance of the Trial Master File • Perform CSS and CRA duties as needed • Perform other duties assigned by management • Supervise the project team

🎯 Exigences

• Bachelor’s Degree or equivalent experience • Previous managerial, or relevant experience, required • Excellent written verbal and non-verbal communication skills • Excellent supervisory, interpersonal, and presentation skills • Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution • Solution driven • Knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.) • 10% travel as required

🏖️ Avantages

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match • Tuition reimbursement • Flexible work environment • Discretionary Time Off • Paid Holidays • Employee assistance programs • Medical, Dental, and vision coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short term disability • Long term disability • Life insurance • Discount programs

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