Manager, Clinical Data Management

🕒 il y a 2 mois

🇵🇱 Pologne – Télétravail

💵 $95 500 - $159 000 / an

⏰ Temps Plein

🟠 Senior

🔴 Expert

🧪 Chercheur Clinique

👻 Score fantôme 6%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Alimentiv

Alimentiv

201 - 500 employés

Fondée en 2020

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Alimentiv est une organisation de recherche sous contrat spécialisée dans les maladies gastro-intestinales (GI) et hépatiques. Avec plus de 30 ans d'expérience, Alimentiv offre une gamme complète de services de recherche clinique et d'imagerie, incluant la gestion d'essais cliniques, la gestion de sites, les affaires réglementaires et la médecine de précision. L'entreprise est à la pointe de la recherche et du développement médical, offrant des solutions d'imagerie de pointe et des analyses de biomarqueurs exploitables. Alimentiv soutient le développement de composés GI et est active dans plus de 60 pays, travaillant avec un réseau d'experts médicaux et opérationnels pour accélérer les essais cliniques et le recrutement de patients.

Description

• Ensure operational efficiency and excellence by leading and/or assisting in the creation and documentation of new or revised department procedures. • Recommend appropriate departmental objectives that support the company strategy and objectives and create solutions to address business and operational challenges. • Lead working groups and/or committees to set goals and execute on implementation to address process or procedural gaps. • Partner with internal and external stakeholders to optimize Data Management technology, processes, and standards. • Participate in project and department budget development and responsible for effective management of budgets for assigned projects and staff. • Participate in the evaluation and selection of data system vendors to enhance Data Management processes, e.g. EDC, IRT, ePRO, eConsent. • Contribute to the financial success of the department and company by effectively managing financial aspects of assigned programs, including but not limited to Work Orders, Change Orders, study forecasting and budgeting. • Identify and quantify resource requirements for ongoing and future projects; Interview, hire, onboard and train new staff as appropriate. • Supervise, mentor, provide leadership and maintain positive team morale; facilitates conflict resolution. • Oversee development of direct reports by setting and tracking individual objectives and key results to support department and company strategies and objectives. • Evaluate training needs and conduct performance reviews for assigned staff. • Set priorities and oversee activities for assigned staff. • Ensure Data Management deliverables for projects assigned meet/exceed project/study team expectations regarding quality, time, and cost. • Serve as the subject matter expert on data collection strategy and handling of study data for assigned programs and effectively liaise with programming to ensure clinical databases are designed in a standard, accurate, complete, and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission. • Proactively identify data management project issues, manage risks, and alert Senior Department Management with a view to remedial action. • Interact/liaise with other departments to ensure a high level of client satisfaction through successful issue resolution and execution of projects. • May work with other departments and analysts on special projects to ensure company end to end processes and technologies are efficient and effective, work seamlessly together and deliver improved customer value. • May represent Data Management at business development, sponsor, or other professional meetings. • Assist the business development team with RFIs, RFPs and project pricing.

🎯 Exigences

• Applicants should have a minimum of a college diploma/degree and 7-9 years of relevant experience. CCDM certification is considered an asset.

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