Manager, Database Programming

🕒 il y a 5 jours

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

💵 $100 000 - $115 000 / an

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

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Veristat

Site WebLinkedInTous les Emplois

501 - 1000 employés

💊 Pharmaceutique

🧬 Biotechnologie

🤝 B2B

💰 Private equity en 2021-05

Pharmaceuticals • Biotechnology • B2B

Veristat est une société de services de développement clinique qui offre un soutien complet et axé sur la réglementation pour les promoteurs de produits biopharmaceutiques et de dispositifs médicaux. L'entreprise propose des services complets de planification et de conduite d'essais cliniques, des affaires réglementaires et un soutien aux soumissions (y compris NDA/MAA et les interactions avec des agences comme la PMDA), des services statistiques et de biométrie, de rédaction médicale, de pharmacovigilance, et de gestion de projet pour des domaines thérapeutiques complexes tels que l'oncologie, les maladies rares, la neurologie, les produits biologiques, et les thérapies cellulaires et géniques. Veristat opère en tant que partenaire B2B pour les organisations biotechnologiques et pharmaceutiques afin de réduire le risque de développement et d'accélérer l'approbation réglementaire.

Description

• Responsible for the operational leadership of Veristat’s Clinical Database Programming (CDP) team(s). • Support of study level strategy. • Development of Clinical Data Management Systems (CDMS) in compliance with statutory regulations and Veristat Standard Operating Procedures.

🎯 Exigences

• Bachelor’s (or equivalent) degree in related field preferred or 8 years of relevant experience as a database programmer required. • 8 years of clinical data management and/or clinical database programming experience (including leading projects) required. • 3 + years of supervisory experience or 5+ years of lead experience required. • Extensive experience working for a pharma/biotech sponsor or clinical CRO with specific focus on developing and implementing EDC and web reporting tools. • Demonstrated ability to lead by example and demonstrated skill for technical and supervisory leadership of staff. • Excellent written and oral communication skills including grammatical/technical writing skills and presentation skills. • Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical/biotech companies. • Excellent interpersonal, communication, and organizational skills with the ability to work independently as well as in a team environment. • Experience in, and awareness of, current and emerging EDC systems. • Proven track record at delivering projects on time and within budget. • Extensive knowledge of software validation within a clinical research environment. • Experience of data management principles as applied in an EDC environment. • Ability to develop the best project management tools and use of software appropriate to delivery of such a project. • Knowledge and experience of industry regulations and guidelines as pertaining to EDC system deployment and support specifically 21 CFR Part 11. • Knowledge of and experience with implementing CDISC standards. • Knowledge of and experience programming SAS preferred.

🏖️ Avantages

• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans